Trial Outcomes & Findings for Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia (NCT NCT00265382)
NCT ID: NCT00265382
Last Updated: 2021-03-03
Results Overview
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
26 weeks
Results posted on
2021-03-03
Participant Flow
This study enrolled adolescent subjects with schizophrenia, ages 13-17 years, who participated in the double-blind placebo controlled Study A1281134 (NCT00257192) who met qualification criteria and wished to receive treatment with open-label ziprasidone.
Participant milestones
| Measure |
Ziprasidone
Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kilograms (kg). For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day \[BID\]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Overall Study
STARTED
|
221
|
|
Overall Study
COMPLETED
|
76
|
|
Overall Study
NOT COMPLETED
|
145
|
Reasons for withdrawal
| Measure |
Ziprasidone
Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kilograms (kg). For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day \[BID\]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Overall Study
Adverse Event
|
21
|
|
Overall Study
Laboratory Abnormality
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Miscellaneous
|
6
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Study terminated by sponsor
|
94
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia
Baseline characteristics by cohort
| Measure |
Ziprasidone
n=221 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Age, Customized
>12 years and <13 years at start of treatment
|
3 Participants
n=39 Participants
|
|
Age, Customized
13 to 17 years
|
218 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Safety Analysis Set = all subjects who took at least one dose of study medication. In this table, the number of subjects with AEs is based on a 0% AE threshold whereas the number of subjects with AEs reported in the AE section are based on a 5% AE threshold.
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Outcome measures
| Measure |
Ziprasidone
n=221 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
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|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
137 participants
|
|
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26, Early Termination (ET)Population: Safety Analysis Set. N=number of subjects with analyzable data at baseline. Baseline data from Study A1281134 (NCT00257192) served as the baseline for A1281135.
Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Outcome measures
| Measure |
Ziprasidone
n=73 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
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|---|---|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, Week 26 (Stage 1)
|
1 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, Week 26 (Stage 2)
|
1 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, Week 26 (Stage 3)
|
11 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, Week 26 (Stage 4)
|
39 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, Week 26 (Stage 5)
|
21 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, ET (Stage 1)
|
0 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, ET (Stage 2)
|
10 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, ET (Stage 3)
|
22 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, ET (Stage 4)
|
59 participants
|
|
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Pubic Hair, ET (Stage 5)
|
30 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 6, 18, 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). Last Observation Carried Forward (LOCF) imputation used for Week 26 LOCF time point.
CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.
Outcome measures
| Measure |
Ziprasidone
n=208 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
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|---|---|
|
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Week 2 (n=178)
|
-0.3 scores on a scale
Standard Deviation 4.8
|
|
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Week 6 (n=153)
|
-0.8 scores on a scale
Standard Deviation 6.1
|
|
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Week 18 (n=93)
|
-0.5 scores on a scale
Standard Deviation 6.5
|
|
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Week 26 (n=68)
|
0.7 scores on a scale
Standard Deviation 7.7
|
|
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
ET (n=113)
|
0.5 scores on a scale
Standard Deviation 7.1
|
|
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Week 26 LOCF (n=177)
|
-0.5 scores on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.
Outcome measures
| Measure |
Ziprasidone
n=214 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 1 (n=198)
|
-1.4 scores on a scale
Standard Deviation 4.8
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 2 (n=188)
|
-2.2 scores on a scale
Standard Deviation 6.1
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 6 (n=160)
|
-3.5 scores on a scale
Standard Deviation 6.3
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 10 (n=129)
|
-4.6 scores on a scale
Standard Deviation 7.3
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 14 (n=105)
|
-5.0 scores on a scale
Standard Deviation 7.4
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 18 (n=94)
|
-4.9 scores on a scale
Standard Deviation 8.1
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 22 (n=78)
|
-5.1 scores on a scale
Standard Deviation 7.9
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 26 (n=72)
|
-5.3 scores on a scale
Standard Deviation 7.8
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
ET (n=122)
|
-2.7 scores on a scale
Standard Deviation 7.3
|
|
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Week 26 LOCF (n=197)
|
-4.5 scores on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6 and 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Outcome measures
| Measure |
Ziprasidone
n=212 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
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|---|---|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Sedation: Week 6 (n=149)
|
0.1 scores on a scale
Standard Deviation 1.7
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Sedation: Week 26 (n=70)
|
-0.2 scores on a scale
Standard Deviation 1.5
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Sedation: ET (n=102)
|
-0.1 scores on a scale
Standard Deviation 2.0
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Sedation: Week 26 LOCF (n=153)
|
-0.2 scores on a scale
Standard Deviation 1.7
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Verbal Memory: Week 6 (n=150)
|
-1.3 scores on a scale
Standard Deviation 13.7
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Verbal Memory: Week 26 (n=71)
|
0.6 scores on a scale
Standard Deviation 14.0
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Verbal Memory: ET (n=103)
|
-0.7 scores on a scale
Standard Deviation 14.6
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Verbal Memory: Week 26 LOCF (n=155)
|
0.3 scores on a scale
Standard Deviation 14.5
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Visual Memory: Week 6 (n=148)
|
-3.6 scores on a scale
Standard Deviation 13.7
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Visual Memory: Week 26 (n=71)
|
-2.1 scores on a scale
Standard Deviation 15.5
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Visual Memory: ET (n=103)
|
-1.9 scores on a scale
Standard Deviation 12.7
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Visual Memory: Week 26 LOCF (n=154)
|
-1.5 scores on a scale
Standard Deviation 14.4
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Processing Speed: Week 6 (n=148)
|
-1.2 scores on a scale
Standard Deviation 11.4
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Processing Speed: Week 26 (n=71)
|
2.1 scores on a scale
Standard Deviation 10.2
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Processing Speed: ET (n=103)
|
-1.4 scores on a scale
Standard Deviation 19.0
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Processing Speed: Week 26 LOCF (n=153)
|
0.5 scores on a scale
Standard Deviation 12.0
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Reasoning: Week 6 (n=145)
|
-0.3 scores on a scale
Standard Deviation 14.1
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Reasoning: Week 26 (n=71)
|
3.0 scores on a scale
Standard Deviation 11.3
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Reasoning: ET (n=100)
|
1.9 scores on a scale
Standard Deviation 14.9
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Reasoning: Week 26 LOCF (n=151)
|
1.5 scores on a scale
Standard Deviation 14.3
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Executive Functioning: Week 6 (n=145)
|
2.0 scores on a scale
Standard Deviation 16.7
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Executive Functioning: Week 26 (n=71)
|
2.0 scores on a scale
Standard Deviation 16.8
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Executive Functioning: ET (n=100)
|
2.4 scores on a scale
Standard Deviation 15.7
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Executive Functioning: Week 26 LOCF (n=151)
|
2.4 scores on a scale
Standard Deviation 16.9
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Working Memory: Week 6 (n=145)
|
-0.5 scores on a scale
Standard Deviation 12.6
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Working Memory: Week 26 (n=68)
|
0.8 scores on a scale
Standard Deviation 16.4
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Working Memory: ET (n=99)
|
0.3 scores on a scale
Standard Deviation 12.1
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Working Memory: Week 26 LOCF (n=150)
|
0.7 scores on a scale
Standard Deviation 14.2
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Sustained Attention: Week 6 (n=145)
|
0.2 scores on a scale
Standard Deviation 12.0
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Sustained Attention: Week 26 (n=68)
|
1.9 scores on a scale
Standard Deviation 14.0
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Sustained Attention: ET (n=99)
|
-0.6 scores on a scale
Standard Deviation 12.2
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Sustained Attention: Week 26 LOCF (n=150)
|
1.2 scores on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6 and 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Outcome measures
| Measure |
Ziprasidone
n=208 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Neurocognitive Index: Week 6 (n=144)
|
-0.6 scores on a scale
Standard Deviation 7.2
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Neurocognitive Index: Week 26 (n=68)
|
1.3 scores on a scale
Standard Deviation 7.3
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Neurocognitive Index: ET (n=99)
|
0.5 scores on a scale
Standard Deviation 6.3
|
|
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Neurocognitive Index: Week 26 LOCF (n=150)
|
0.7 scores on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.
Outcome measures
| Measure |
Ziprasidone
n=221 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 1 (n=206)
|
-0.05 scores on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 2 (n=197)
|
-0.11 scores on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 6 (n=168)
|
-0.04 scores on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 10 (n=135)
|
-0.10 scores on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 14 (n=110)
|
-0.02 scores on a scale
Standard Deviation 1.9
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 18 (n=99)
|
0.02 scores on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 22 (n=82)
|
-0.04 scores on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 26 (n=76)
|
-0.32 scores on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
ET (n=127)
|
-0.31 scores on a scale
Standard Deviation 2.0
|
|
Change From Baseline in Simpson-Angus Rating Scale (SARS)
Week 26 LOCF (n=206)
|
-0.15 scores on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.
Outcome measures
| Measure |
Ziprasidone
n=221 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 1 (n=206)
|
0.0 scores on a scale
Standard Deviation 0.4
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 2 (n=197)
|
0.0 scores on a scale
Standard Deviation 0.4
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 6 (n=168)
|
0.0 scores on a scale
Standard Deviation 0.4
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 10 (n=135)
|
0.0 scores on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 14 (n=110)
|
0.1 scores on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 18 (n=99)
|
0.0 scores on a scale
Standard Deviation 0.4
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 22 (n=82)
|
0.0 scores on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 26 (n=76)
|
0.0 scores on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
ET (n=127)
|
0.0 scores on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Week 26 LOCF (n=206)
|
0.1 scores on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.
Outcome measures
| Measure |
Ziprasidone
n=221 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 1 (n=206)
|
0.06 scores on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 2 (n=197)
|
-0.05 scores on a scale
Standard Deviation 0.7
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 6 (n=168)
|
-0.04 scores on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 10 (n=135)
|
0.02 scores on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 14 (n=110)
|
0.01 scores on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 18 (n=99)
|
0.01 scores on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 22 (n=82)
|
0.10 scores on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 26 (n=76)
|
0.08 scores on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
ET (n=127)
|
-0.12 scores on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Week 26 LOCF (n=206)
|
0.00 scores on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 6, 18, 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
Outcome measures
| Measure |
Ziprasidone
n=220 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
Week 26 LOCF (n=196)
|
-6.9 scores on a scale
Standard Deviation 8.9
|
|
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
Week 26 (n=75)
|
-8.5 scores on a scale
Standard Deviation 9.9
|
|
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
Week 2 (n=196)
|
-3.8 scores on a scale
Standard Deviation 7.8
|
|
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
ET (n=127)
|
-4.0 scores on a scale
Standard Deviation 9.1
|
|
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
Week 6 (n=167)
|
-6.1 scores on a scale
Standard Deviation 8.8
|
|
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
Week 18 (n=98)
|
-7.8 scores on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 6, 18, 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.
Outcome measures
| Measure |
Ziprasidone
n=221 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Change From Baseline in Children's Global Assessment Scale (CGAS)
Week 18 (n=99)
|
62.3 scores on a scale
Standard Deviation 11.4
|
|
Change From Baseline in Children's Global Assessment Scale (CGAS)
Week 2 (n=197)
|
55.5 scores on a scale
Standard Deviation 12.9
|
|
Change From Baseline in Children's Global Assessment Scale (CGAS)
Week 6 (n=168)
|
59.2 scores on a scale
Standard Deviation 12.5
|
|
Change From Baseline in Children's Global Assessment Scale (CGAS)
Week 26 (n=76)
|
65.6 scores on a scale
Standard Deviation 12.4
|
|
Change From Baseline in Children's Global Assessment Scale (CGAS)
ET (n=127)
|
56.6 scores on a scale
Standard Deviation 15.1
|
|
Change From Baseline in Children's Global Assessment Scale (CGAS)
Week 26 LOCF (n=197)
|
60.5 scores on a scale
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6 and 26, ETPopulation: Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
Outcome measures
| Measure |
Ziprasidone
n=220 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Emotion, Behavior: Week 26 LOCF (n=163)
|
54.8 scores on a scale
Standard Deviation 32.2
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Time Impact on Parent: Week 6 (n=163)
|
62.0 scores on a scale
Standard Deviation 26.6
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Time Impact on Parent: Week 26 (n=75)
|
69.9 scores on a scale
Standard Deviation 23.5
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Health: ET (n=123)
|
75.5 scores on a scale
Standard Deviation 32.8
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Health: Week 26 LOCF (n=163)
|
77.8 scores on a scale
Standard Deviation 31.2
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Bodily Pain: Week 6 (n=163)
|
80.8 scores on a scale
Standard Deviation 21.6
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Bodily Pain: Week 26 (n=75)
|
84.4 scores on a scale
Standard Deviation 21.5
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Bodily Pain: ET (n=124)
|
81.0 scores on a scale
Standard Deviation 22.7
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Emotion, Behavior: Week 6 (n=163)
|
53.3 scores on a scale
Standard Deviation 32.6
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Emotion, Behavior: Week 26 (n=74)
|
60.1 scores on a scale
Standard Deviation 31.2
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Emotion, Behavior: ET (n=123)
|
49.5 scores on a scale
Standard Deviation 34.5
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Time Impact on Parent: ET (n=124)
|
59.9 scores on a scale
Standard Deviation 28.6
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Time Impact on Parent: Week 26 LOCF (n=164)
|
65.1 scores on a scale
Standard Deviation 26.3
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Emotional Impact on Parent: Week 6 (n=163)
|
49.5 scores on a scale
Standard Deviation 24.6
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Emotional Impact on Parent: Week 26 (n=75)
|
57.2 scores on a scale
Standard Deviation 24.7
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Emotional Impact on Parent: ET (n=124)
|
43.4 scores on a scale
Standard Deviation 25.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Emotional Impact on Parent: Week 26 LOCF (n=164)
|
52.2 scores on a scale
Standard Deviation 26.0
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Mental Health: Week 6 (n=163)
|
63.6 scores on a scale
Standard Deviation 16.1
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Mental Health: Week 26 (n=75)
|
66.7 scores on a scale
Standard Deviation 16.5
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Mental Health: ET (n=124)
|
60.8 scores on a scale
Standard Deviation 18.3
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Mental Health: Week 26 LOCF (n=164)
|
65.1 scores on a scale
Standard Deviation 16.1
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Function: Week 6 (n=163)
|
80.4 scores on a scale
Standard Deviation 22.3
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Function: Week 26 (n=75)
|
84.9 scores on a scale
Standard Deviation 19.0
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Function: ET (n=124)
|
79.5 scores on a scale
Standard Deviation 23.4
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Function: Week 26 LOCF (n=164)
|
81.4 scores on a scale
Standard Deviation 21.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Behavior Scale: Week 6 (n=163)
|
62.7 scores on a scale
Standard Deviation 16.8
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Behavior Scale: Week 26 (n=75)
|
64.5 scores on a scale
Standard Deviation 20.0
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Behavior Scale: ET (n=124)
|
60.2 scores on a scale
Standard Deviation 18.7
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Behavior Scale: Week 26 LOCF (n=164)
|
63.0 scores on a scale
Standard Deviation 18.4
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Self-Esteem: Week 6 (n=163)
|
52.7 scores on a scale
Standard Deviation 20.3
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Self-Esteem: Week 26 (n=74)
|
55.3 scores on a scale
Standard Deviation 21.0
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Self-Esteem: ET (n=124)
|
52.6 scores on a scale
Standard Deviation 21.7
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Self-Esteem: Week 26 LOCF (n=163)
|
54.5 scores on a scale
Standard Deviation 20.6
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
General Health Perception: Week 6 (n=163)
|
50.3 scores on a scale
Standard Deviation 15.3
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
General Health Perception: Week 26 (n=75)
|
51.8 scores on a scale
Standard Deviation 16.4
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
General Health Perception: ET (n=124)
|
49.7 scores on a scale
Standard Deviation 15.1
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
General Health Perception: Week 26 LOCF (n=164)
|
50.3 scores on a scale
Standard Deviation 15.4
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Family Activities: Week 6 (n=163)
|
60.1 scores on a scale
Standard Deviation 24.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Family Activities: Week 26 (n=75)
|
63.9 scores on a scale
Standard Deviation 24.1
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Family Activities: ET (n=124)
|
56.3 scores on a scale
Standard Deviation 27.6
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Family Activities: Week 26 LOCF (n=164)
|
61.6 scores on a scale
Standard Deviation 26.1
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Health Global Subscale: Week 6 (n=163)
|
44.1 scores on a scale
Standard Deviation 11.7
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Health Global Subscale: Week 26 (n=74)
|
46.6 scores on a scale
Standard Deviation 10.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Health Global: ET (n=123)
|
43.8 scores on a scale
Standard Deviation 12.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Health Global: Week 26 LOCF (n=163)
|
44.8 scores on a scale
Standard Deviation 12.2
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Psychosocial Health Global: Week 6 (n=163)
|
35.7 scores on a scale
Standard Deviation 10.4
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Psychosocial Health Global: Week 26 (n=74)
|
38.5 scores on a scale
Standard Deviation 10.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Psychosocial Health Global: ET (n=123)
|
33.7 scores on a scale
Standard Deviation 11.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Psychosocial Health Global: Week 26 LOCF (n=163)
|
36.8 scores on a scale
Standard Deviation 10.7
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Global Health: Week 26 (n=75)
|
50.3 scores on a scale
Standard Deviation 22.1
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Global Health: ET (n=124)
|
40.5 scores on a scale
Standard Deviation 25.8
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Bodily Pain: Week 26 LOCF (n=164)
|
82.5 scores on a scale
Standard Deviation 21.3
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Global Health: Week 6 (n=163)
|
44.2 scores on a scale
Standard Deviation 23.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Global Health: Week 26 LOCF (n=164)
|
44.9 scores on a scale
Standard Deviation 22.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Global Behavior: Week 6 (n=163)
|
44.9 scores on a scale
Standard Deviation 23.6
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Global Behavior: Week 26 (n=75)
|
47.0 scores on a scale
Standard Deviation 24.2
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Global Behavior: ET (n=124)
|
38.7 scores on a scale
Standard Deviation 25.8
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Global Behavior: Week 26 LOCF (n=164)
|
43.8 scores on a scale
Standard Deviation 24.4
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Family Cohesion: Week 6 (n=163)
|
53.0 scores on a scale
Standard Deviation 23.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Family Cohesion: Week 26 (n=75)
|
54.4 scores on a scale
Standard Deviation 24.7
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Family Cohesion: ET (n=124)
|
50.0 scores on a scale
Standard Deviation 23.9
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Family Cohesion: Week 26 LOCF (n=164)
|
53.4 scores on a scale
Standard Deviation 23.7
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Health: Week 6 (n=163)
|
76.4 scores on a scale
Standard Deviation 30.8
|
|
Change From Baseline in Child Health Questionnaire (CHQ)
Physical Health: Week 26 (n=74)
|
80.2 scores on a scale
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6 and 26, ETPopulation: Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Outcome measures
| Measure |
Ziprasidone
n=221 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Baseline: Enrolled or Attend (n=221)
|
63 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Baseline: Not Attend or Mental Illness (n=221)
|
59 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Baseline: Not Attend or Other (n=221)
|
4 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Baseline: Enrolled or Vacation (n=221)
|
26 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Baseline: Not Enrolled or Mental Illness (n=221)
|
42 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Baseline: Not Enrolled or Other (n=221)
|
27 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 6: Enrolled or Attend (n=166)
|
68 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 6: Not Attend or Mental Illness (n=166)
|
32 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 6: Not Attend or Other (n=166)
|
1 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 6: Enrolled or Vacation (n=166)
|
14 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 6: Not Enrolled or Mental Illness (n=166)
|
29 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 6: Not Enrolled or Other (n=166)
|
22 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26: Enrolled or Attend (n=75)
|
35 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26: Not Attend or Mental Illness (n=75)
|
9 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26: Not Attend or Other (n=75)
|
0 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26: Enrolled or Vacation (n=75)
|
5 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26: Not Enrolled or Mental Illness (n=75)
|
13 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
ET: Enrolled or Attend (n=125)
|
42 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
ET: Not Attend or Mental Illness (n=125)
|
35 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
ET: Not Attend or Other (n=125)
|
1 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
ET: Enrolled or Vacation (n=125)
|
9 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
ET: Not Enrolled or Mental Illness (n=125)
|
21 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
ET: Not Enrolled or Other (n=125)
|
17 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26 LOCF: Enrolled or Attend (n=166)
|
75 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26 LOCF: Not Attend or Mental Illness (n=166)
|
30 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26 LOCF: Not Attend or Other (n=166)
|
1 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26 LOCF: Enrolled or Vacation (n=166)
|
8 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Wk 26 LOCF: Not Enrolled or Mental Illness (n=166)
|
28 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26 LOCF: Not Enrolled or Other (n=166)
|
24 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Week 26: Not Enrolled or Other (n=75)
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6 and 26, ETPopulation: Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Outcome measures
| Measure |
Ziprasidone
n=133 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Baseline: No Absences (n=133)
|
25 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Baseline: Only a Few Absences (n=133)
|
37 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Baseline: Frequent Absences (n=133)
|
12 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Baseline: Did Not Attend (n=133)
|
36 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Baseline: Not Applicable or Vacation (n=133)
|
23 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 6: No Absences (n=95)
|
31 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 6: Only a Few Absences (n=95)
|
29 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 6: Frequent Absences (n=95)
|
11 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 6: Did Not Attend (n=95)
|
10 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 6: Not Applicable or Vacation (n=95)
|
14 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26: No Absences (n=42)
|
14 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26: Only a Few Absences (n=42)
|
16 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26: Frequent Absences (n=42)
|
7 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26: Did Not Attend (n=42)
|
0 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26: Not Applicable or Vacation (n=42)
|
5 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
ET: No Absences (n=62)
|
16 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
ET: Only a Few Absences (n=62)
|
23 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
ET: Frequent Absences (n=62)
|
5 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
ET: Did Not Attend (n=62)
|
11 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
ET: Not Applicable or Vacation (n=62)
|
7 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26 LOCF: No Absences (n=93)
|
32 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26 LOCF: Only a Few Absences (n=93)
|
32 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26 LOCF: Frequent Absences (n=93)
|
14 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26 LOCF: Did Not Attend (n=93)
|
7 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Week 26 LOCF: Not Applicable or Vacation (n=93)
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6 and 26, ETPopulation: Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Outcome measures
| Measure |
Ziprasidone
n=103 Participants
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kg. For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Baseline: Excellent (n=103)
|
5 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Baseline: Good (n=103)
|
25 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Baseline: Fair (n=103)
|
40 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Baseline: Poor (n=103)
|
23 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Baseline: Very Poor (n=103)
|
10 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 6: Excellent (n=73)
|
2 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 6: Good (n=73)
|
23 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 6: Fair (n=73)
|
34 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 6: Poor (n=73)
|
14 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 6: Very Poor (n=73)
|
0 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26: Excellent (n=37)
|
1 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26: Good (n=37)
|
10 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26: Fair (n=37)
|
18 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26: Poor (n=37)
|
5 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26: Very Poor (n=37)
|
3 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
ET: Excellent (n=48)
|
0 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
ET: Good (n=48)
|
15 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
ET: Fair (n=48)
|
23 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
ET: Poor (n=48)
|
6 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
ET: Very Poor (n=48)
|
4 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26 LOCF: Excellent (n=80)
|
1 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26 LOCF: Good (n=80)
|
22 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26 LOCF: Fair (n=80)
|
39 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26 LOCF: Poor (n=80)
|
15 participants
|
|
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Week 26 LOCF: Very Poor (n=80)
|
3 participants
|
Adverse Events
Ziprasidone
Serious events: 16 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ziprasidone
n=221 participants at risk
Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kilograms (kg). For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day \[BID\]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
General disorders
Drug ineffective
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dystonia
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Aggression
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Agitation
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Anxiety
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Completed suicide
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Delusional perception
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Hallucination
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.90%
2/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Intentional self-injury
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Major depression
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.90%
2/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Persecutory delusion
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Schizophrenia
|
1.8%
4/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Self injurious behaviour
|
0.90%
2/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
3/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Thinking abnormal
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Social circumstances
Sexual activity increased
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Social circumstances
Victim of sexual abuse
|
0.45%
1/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
Other adverse events
| Measure |
Ziprasidone
n=221 participants at risk
Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing \> = 45 kilograms (kg). For subjects with a body weight \< 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day \[BID\]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
|
|---|---|
|
Nervous system disorders
Headache
|
9.0%
20/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Somnolence
|
14.9%
33/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Tremor
|
6.3%
14/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Fatigue
|
5.0%
11/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Insomnia
|
5.0%
11/221 • Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER