Trial Outcomes & Findings for Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone (NCT NCT00406315)
NCT ID: NCT00406315
Last Updated: 2021-03-29
Results Overview
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
COMPLETED
PHASE4
255 participants
Baseline, Week 16, Week 16 LOCF
2021-03-29
Participant Flow
An additional 14 subjects had a baseline visit but were never treated.
Participant milestones
| Measure |
Ziprasidone
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Overall Study
STARTED
|
241
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
141
|
Reasons for withdrawal
| Measure |
Ziprasidone
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
39
|
|
Overall Study
Laboratory Abnormality
|
4
|
|
Overall Study
Lack of Efficacy
|
13
|
|
Overall Study
Other
|
33
|
|
Overall Study
Lost to Follow-up
|
21
|
|
Overall Study
Withdrawal by Subject
|
30
|
Baseline Characteristics
Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
Baseline characteristics by cohort
| Measure |
Ziprasidone
n=241 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Age, Customized
< 18 years
|
0 participants
n=39 Participants
|
|
Age, Customized
18 to 44 years
|
140 participants
n=39 Participants
|
|
Age, Customized
45 to 64 years
|
101 participants
n=39 Participants
|
|
Age, Customized
> = 65 years
|
0 participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16, Week 16 LOCFPopulation: Safety population = all enrolled subjects who took at least 1 dose of study medication. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=231 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Weight at Week 16
Week 16 (n=133)
|
-1.09 kilogram
Standard Deviation 3.918
|
|
Change From Baseline in Weight at Week 16
Week 16 LOCF (n=231)
|
-0.73 kilogram
Standard Deviation 3.725
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Safety population.
Total cholesterol value: Change = value at Week 16 minus value at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=128 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
|
-3.0 milligram (mg)/deciliter (dL)
Standard Deviation 31.14
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Safety population.
HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=128 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
HDL (n=128)
|
-0.2 mg/dL
Standard Deviation 9.32
|
|
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
LDL (n=123)
|
-2.5 mg/dL
Standard Deviation 25.66
|
|
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
Triglycerides (n=128)
|
-1.6 mg/dL
Standard Deviation 84.58
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Safety population.
HbAlc value: Change = value at Week 16 minus value at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=127 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
|
0.1 percent
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Safety population.
Fasting glucose value: Change = value at Week 16 minus value at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=128 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Fasting Glucose at Week 16
|
3.0 mg/dL
Standard Deviation 17.84
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Safety population.
Fasting insulin value: Change = value at Week 16 minus value at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=118 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Fasting Insulin at Week 16
|
134.8 microinternational (mciu)/milliliter(mL)
Standard Deviation 851.28
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Safety population.
Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=132 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Waist and Hip Circumference at Week 16
Waist (n=132)
|
-2.9 centimeter
Standard Deviation 17.53
|
|
Change From Baseline in Waist and Hip Circumference at Week 16
Hip (n=131)
|
-3.0 centimeter
Standard Deviation 18.21
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Safety population.
AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=144 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
AIMS Total Score
|
0.05 scores on a scale
Standard Deviation 2.251
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
AIMS Global Severity Score
|
0.03 scores on a scale
Standard Deviation 0.472
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
AIMS Global Incapacitation Score
|
0.01 scores on a scale
Standard Deviation 0.383
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 LOCFPopulation: Intent-to-treat population (ITT) = all enrolled subjects with baseline and at least 1 post baseline efficacy evaluation. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=231 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Total Score, Week 16 (n=144)
|
-10.22 scores on a scale
Standard Deviation 15.027
|
|
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Total Score, Week 16 LOCF (n=231)
|
-6.61 scores on a scale
Standard Deviation 15.306
|
|
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Positive Subscale Score, Week 16 (n=144)
|
-3.30 scores on a scale
Standard Deviation 4.658
|
|
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Positive Subscale Score, Week 16 LOCF (n=231)
|
-2.43 scores on a scale
Standard Deviation 4.634
|
|
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Negative Subscale Score, Week 16 (n=144)
|
-1.67 scores on a scale
Standard Deviation 4.147
|
|
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Negative Subscale Score, Week 16 LOCF (n=231)
|
-0.92 scores on a scale
Standard Deviation 4.373
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 LOCFPopulation: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=231 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
Week 16 (n=135)
|
-0.76 scores on a scale
Standard Deviation 0.868
|
|
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
Week 16 LOCF (n=231)
|
-0.47 scores on a scale
Standard Deviation 0.848
|
SECONDARY outcome
Timeframe: Week 16, Week 16 LOCFPopulation: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Outcome measures
| Measure |
Ziprasidone
n=231 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
Week 16 LOCF (n=231)
|
3.2 scores on a scale
Standard Deviation 1.22
|
|
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
Week 16 (n=135)
|
2.7 scores on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 LOCFPopulation: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=231 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
Week 16 (n=144)
|
-2.55 scores on a scale
Standard Deviation 4.364
|
|
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
Week 16 LOCF (n=231)
|
-1.58 scores on a scale
Standard Deviation 4.526
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 LOCFPopulation: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=169 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
Total Score, Week 16 (n=137)
|
-4.61 scores on a scale
Standard Deviation 7.981
|
|
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
Total Score, Week 16 LOCF (n=169)
|
-4.21 scores on a scale
Standard Deviation 8.961
|
|
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
Global Rating, Week 16 (n=137)
|
-1.02 scores on a scale
Standard Deviation 1.708
|
|
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
Global Rating, Week 16 LOCF (n=169)
|
-0.88 scores on a scale
Standard Deviation 1.643
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 LOCFPopulation: ITT. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=230 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
Week 16 (n=145)
|
7.88 scores on a scale
Standard Deviation 11.029
|
|
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
Week 16 LOCF (n=230)
|
5.27 scores on a scale
Standard Deviation 10.626
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 16 LOCFPopulation: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Outcome measures
| Measure |
Ziprasidone
n=180 Participants
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Side Effect, Week 16 LOCF (n=167)
|
18.49 scores on a scale
Standard Deviation 42.883
|
|
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Effectiveness, Week 16 (n=178)
|
10.49 scores on a scale
Standard Deviation 30.662
|
|
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Effectiveness, Week 16 LOCF (n=178)
|
10.49 scores on a scale
Standard Deviation 30.662
|
|
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Side Effect, Week 16 (n=167)
|
18.49 scores on a scale
Standard Deviation 42.883
|
|
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Convenience, Week 16 (n=180)
|
6.45 scores on a scale
Standard Deviation 23.630
|
|
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Convenience, Week 16 LOCF (n=180)
|
6.45 scores on a scale
Standard Deviation 23.630
|
|
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Global Satisfaction, Week 16 (n=179)
|
15.32 scores on a scale
Standard Deviation 36.304
|
|
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Global Satisfaction, Week 16 LOCF (n=179)
|
15.32 scores on a scale
Standard Deviation 36.304
|
Adverse Events
Ziprasidone
Serious adverse events
| Measure |
Ziprasidone
n=241 participants at risk
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.41%
1/241
|
|
Infections and infestations
Lung infection
|
0.41%
1/241
|
|
Nervous system disorders
Dystonia
|
0.41%
1/241
|
|
Psychiatric disorders
Aggression
|
0.41%
1/241
|
|
Psychiatric disorders
Delusion of grandeur
|
0.41%
1/241
|
|
Psychiatric disorders
Depression
|
0.83%
2/241
|
|
Psychiatric disorders
Hallucination, auditory
|
0.41%
1/241
|
|
Psychiatric disorders
Insomnia
|
0.41%
1/241
|
|
Psychiatric disorders
Mental disorder
|
0.41%
1/241
|
|
Psychiatric disorders
Psychotic disorder
|
1.2%
3/241
|
|
Psychiatric disorders
Schizoaffective disorder
|
1.7%
4/241
|
|
Psychiatric disorders
Schizophrenia
|
1.7%
4/241
|
|
Psychiatric disorders
Self injurious behaviour
|
0.41%
1/241
|
|
Psychiatric disorders
Suicidal ideation
|
0.83%
2/241
|
|
Psychiatric disorders
Suicide attempt
|
0.83%
2/241
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.41%
1/241
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal polyp
|
0.41%
1/241
|
Other adverse events
| Measure |
Ziprasidone
n=241 participants at risk
For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
11.6%
28/241
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
16/241
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
12/241
|
|
Nervous system disorders
Akathisia
|
6.2%
15/241
|
|
Nervous system disorders
Dizziness
|
5.4%
13/241
|
|
Nervous system disorders
Headache
|
10.0%
24/241
|
|
Nervous system disorders
Sedation
|
7.1%
17/241
|
|
Nervous system disorders
Somnolence
|
14.5%
35/241
|
|
Psychiatric disorders
Anxiety
|
6.2%
15/241
|
|
Psychiatric disorders
Insomnia
|
19.1%
46/241
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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