Trial Outcomes & Findings for Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD) (NCT NCT00880919)
NCT ID: NCT00880919
Last Updated: 2017-03-09
Results Overview
This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.
COMPLETED
PHASE3
95 participants
baseline, weekly until week 8
2017-03-09
Participant Flow
This randomized, double-blind, placebo-controlled, dose comparison trial was conducted at three outpatient treatment centers from January 2010 to March 2013.
Ninety-five persons with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) borderline personality disorder (BPD) were randomly assigned to quetiapine XR 150 mg/day (n=33), quetiapine XR 300 mg/day (n=33), or placebo (n=29).
Participant milestones
| Measure |
Quetiapine XR 150 mg/Day (n=33),
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
29
|
|
Overall Study
COMPLETED
|
18
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)
Baseline characteristics by cohort
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
30.2 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
20.1 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
29.5 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
33 participants
n=107 Participants
|
29 participants
n=206 Participants
|
95 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline, weekly until week 8Population: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)
|
-1.22 units on a scale
Standard Deviation 0.15
|
-0.99 units on a scale
Standard Deviation 0.16
|
-0.75 units on a scale
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: baseline to 8 weeksPopulation: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
|
-0.85 units on a scale
Standard Error 0.19
|
-1.05 units on a scale
Standard Error 0.19
|
-0.59 units on a scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Borderline Evaluation of Severity Over Time (BEST)
|
-2.10 units on a scale
Standard Error 0.32
|
-1.97 units on a scale
Standard Error 0.33
|
-0.91 units on a scale
Standard Error 0.31
|
PRIMARY outcome
Timeframe: Change from Baseline Overt Aggression Scale - Modified to 8 weeksPopulation: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Overt Aggression Scale - Modified (OAS-M)
|
-1.92 units on a scale
Standard Error 0.42
|
-1.82 units on a scale
Standard Error 0.43
|
-0.37 units on a scale
Standard Error 0.43
|
PRIMARY outcome
Timeframe: Change in Global Assessment of Functioning from Baseline to 8 weeksPopulation: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Global Assessment of Functioning Scale (GAF)
|
1.05 units on a scale
Standard Error 0.20
|
1.04 units on a scale
Standard Error 0.21
|
0.62 units on a scale
Standard Error 0.19
|
PRIMARY outcome
Timeframe: Change in Impulsiveness from Baseline to 8 weeksPopulation: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Barratt Impulsiveness Scale (BIS)
|
-0.73 units on a scale
Standard Error 0.27
|
-0.83 units on a scale
Standard Error 0.27
|
-.59 units on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: Change in psychological problems and symptoms from Baseline to 8 weeksPopulation: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Symptom Checklist -90-Revised (SCL-90-R)
|
-0.11 units on a scale
Standard Error 0.02
|
-0.12 units on a scale
Standard Error 0.02
|
-0.07 units on a scale
Standard Error 0.02
|
PRIMARY outcome
Timeframe: Change in manic symptoms from Baseline to 8 weeksPopulation: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Young Mania Rating Scale (YMS)
|
-0.26 units on a scale
Standard Error 0.06
|
-0.30 units on a scale
Standard Error 0.06
|
0.11 units on a scale
Standard Error 0.06
|
PRIMARY outcome
Timeframe: Change in functional impairment from Baseline to 8 weeksPopulation: All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.
Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment
Outcome measures
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 Participants
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 Participants
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 Participants
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Sheehan Disability Scale (SDS)
|
-0.85 units on a scale
Standard Error 0.19
|
-1.11 units on a scale
Standard Error 0.20
|
0.58 units on a scale
Standard Error 0.18
|
Adverse Events
Quetiapine XR 150 mg/Day (n=33),
Quetiapine XR 300 mg/Day (n=33),
Placebo (n=29).
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quetiapine XR 150 mg/Day (n=33),
n=33 participants at risk
Seroquel XR 150mg oral tablets taken daily for 8 weeks.
|
Quetiapine XR 300 mg/Day (n=33),
n=33 participants at risk
Seroquel XR 300mg oral tablets taken daily for 8 weeks.
|
Placebo (n=29).
n=29 participants at risk
Equivalent number of placebo oral tablets taken daily for 8 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Sedation
|
87.9%
29/33 • Number of events 29 • 10 weeks
|
90.9%
30/33 • Number of events 30 • 10 weeks
|
65.5%
19/29 • Number of events 19 • 10 weeks
|
|
Metabolism and nutrition disorders
Change in appetite
|
27.3%
9/33 • Number of events 9 • 10 weeks
|
36.4%
12/33 • Number of events 12 • 10 weeks
|
13.8%
4/29 • Number of events 4 • 10 weeks
|
|
General disorders
Dry mouth
|
27.3%
9/33 • Number of events 9 • 10 weeks
|
42.4%
14/33 • Number of events 14 • 10 weeks
|
3.4%
1/29 • Number of events 1 • 10 weeks
|
|
General disorders
Headache
|
21.2%
7/33 • Number of events 7 • 10 weeks
|
30.3%
10/33 • Number of events 10 • 10 weeks
|
20.7%
6/29 • Number of events 6 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Bodily pain
|
18.2%
6/33 • Number of events 6 • 10 weeks
|
27.3%
9/33 • Number of events 9 • 10 weeks
|
17.2%
5/29 • Number of events 5 • 10 weeks
|
|
General disorders
Hypersomnia
|
15.2%
5/33 • Number of events 5 • 10 weeks
|
24.2%
8/33 • Number of events 8 • 10 weeks
|
6.9%
2/29 • Number of events 2 • 10 weeks
|
|
General disorders
Dizziness
|
15.2%
5/33 • Number of events 5 • 10 weeks
|
21.2%
7/33 • Number of events 7 • 10 weeks
|
3.4%
1/29 • Number of events 1 • 10 weeks
|
|
Nervous system disorders
Forgetfulness or confusion
|
15.2%
5/33 • Number of events 5 • 10 weeks
|
21.2%
7/33 • Number of events 7 • 10 weeks
|
3.4%
1/29 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Nausea or vomiting
|
12.1%
4/33 • Number of events 4 • 10 weeks
|
12.1%
4/33 • Number of events 4 • 10 weeks
|
13.8%
4/29 • Number of events 4 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place