Trial Outcomes & Findings for Brexpiprazole in Borderline Personality Disorder (NCT NCT03418675)
NCT ID: NCT03418675
Last Updated: 2022-03-18
Results Overview
A clinician-administered scale assessing Borderline Personality Scale severity at all study visits. Scores range from 0-36. Higher scores represent worse Borderline Personality Disorder severity, and lower scores represent milder Borderline Personality Disorder severity.
COMPLETED
PHASE2
80 participants
Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)
2022-03-18
Participant Flow
Participant milestones
| Measure |
Placebo
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
Completed All Baseline Measures
|
37
|
40
|
|
Overall Study
Completed One-post Randomization Visit
|
34
|
35
|
|
Overall Study
COMPLETED
|
25
|
30
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
| Measure |
Placebo
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
10
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Brexpiprazole in Borderline Personality Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=37 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=40 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
n=5 Participants
|
30.9 years
n=7 Participants
|
29.9 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown/Not reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Education
Less than HS diploma/GED
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
HS diploma/GED
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
Some college/Associates
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Education
Bachelors
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Education
Masters+
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Unknown/ Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Employment Status
Full-time
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Employment Status
Part-time
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Employment Status
Student
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Employment Status
Retired
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Employment Status
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Employment Status
Unknown/Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Marital Status
Single
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Marital Status
Married
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Marital Status
Divorced/separated
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital Status
Living together/engaged
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Marital Status
Unknown/Not reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)Population: Subjects assigned to Placebo or Rexulti who completed one-post randomization visit.
A clinician-administered scale assessing Borderline Personality Scale severity at all study visits. Scores range from 0-36. Higher scores represent worse Borderline Personality Disorder severity, and lower scores represent milder Borderline Personality Disorder severity.
Outcome measures
| Measure |
Placebo
n=34 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=35 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Zanarini Rating Scale for Borderline Personality Disorder
Visit 1
|
14.9 score on a scale
Interval 9.0 to 26.0
|
14.9 score on a scale
Interval 9.0 to 26.0
|
|
Zanarini Rating Scale for Borderline Personality Disorder
Visit 2
|
7.6 score on a scale
Interval 0.0 to 19.0
|
6.7 score on a scale
Interval 0.0 to 20.0
|
|
Zanarini Rating Scale for Borderline Personality Disorder
Visit 3
|
4.7 score on a scale
Interval 0.0 to 16.0
|
5.3 score on a scale
Interval 0.0 to 17.0
|
|
Zanarini Rating Scale for Borderline Personality Disorder
Visit 4
|
6 score on a scale
Interval 0.0 to 18.0
|
4.4 score on a scale
Interval 0.0 to 19.0
|
|
Zanarini Rating Scale for Borderline Personality Disorder
Visit 5
|
4.2 score on a scale
Interval 0.0 to 15.0
|
4.5 score on a scale
Interval 0.0 to 20.0
|
|
Zanarini Rating Scale for Borderline Personality Disorder
Visit 6
|
5.7 score on a scale
Interval 0.0 to 14.0
|
4.9 score on a scale
Interval 0.0 to 19.0
|
|
Zanarini Rating Scale for Borderline Personality Disorder
Visit 7
|
5 score on a scale
Interval 0.0 to 16.0
|
4 score on a scale
Interval 0.0 to 25.0
|
|
Zanarini Rating Scale for Borderline Personality Disorder
Visit 8
|
8.4 score on a scale
Interval 0.0 to 22.0
|
3.1 score on a scale
Interval 0.0 to 18.0
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)Population: No data displayed because data were not collected. Due to the outbreak of the COVID-19 pandemic and following restrictions, all study visits were moved to teleheath and only essential scales were completed.
A clinician-administered behavior rating scale measuring four types of aggressive behavior that will be assessed at all 9 visits. The subsets range on a scale from 0-4 with 0 indicating no aggression present. This scale tracks changes in level of aggression over time. The total weighted sum of the sections of the scale is recorded. Higher total scores indicate higher aggression levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)Population: No data displayed because data were not collected. Due to the outbreak of the COVID-19 pandemic and following restrictions, all study visits were moved to teleheath and only essential scales were completed.
A clinician-administered, 11 item scale that assesses manic symptoms at baseline and over time. Higher total scores indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in the patient. Subsets of the scale range from 0-4 with 0 indicating no severity. This scale will be assessed at all visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)Population: Subjects assigned to Placebo or Rexulti who completed one-post randomization visit.
A self-report scale assessing Borderline Personality severity that will be assessed at all visits.This scale is assessing severity and change in BPD symptoms. This is a 9-item scale measuring severity of different aspects of Borderline Personality Disorder, with each item rated on a 0-4 scale, 0=no symptoms, 4=severe symptoms. Total scores range from 0-36.
Outcome measures
| Measure |
Placebo
n=34 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=35 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Self Report Version of Zanarini Scale
Visit 1
|
18.2 score on a scale
Interval 8.0 to 36.0
|
17.6 score on a scale
Interval 8.0 to 36.0
|
|
Self Report Version of Zanarini Scale
Visit 2
|
12.8 score on a scale
Interval 0.0 to 36.0
|
10.9 score on a scale
Interval 0.0 to 36.0
|
|
Self Report Version of Zanarini Scale
Visit 3
|
10.7 score on a scale
Interval 0.0 to 36.0
|
7.9 score on a scale
Interval 0.0 to 36.0
|
|
Self Report Version of Zanarini Scale
Visit 4
|
10.7 score on a scale
Interval 0.0 to 36.0
|
8.0 score on a scale
Interval 0.0 to 36.0
|
|
Self Report Version of Zanarini Scale
Visit 5
|
9.7 score on a scale
Interval 0.0 to 36.0
|
7.0 score on a scale
Interval 0.0 to 36.0
|
|
Self Report Version of Zanarini Scale
Visit 6
|
9.6 score on a scale
Interval 0.0 to 36.0
|
6.6 score on a scale
Interval 0.0 to 36.0
|
|
Self Report Version of Zanarini Scale
Visit 7
|
8.7 score on a scale
Interval 0.0 to 36.0
|
6.0 score on a scale
Interval 0.0 to 36.0
|
|
Self Report Version of Zanarini Scale
Visit 8
|
9.3 score on a scale
Interval 0.0 to 36.0
|
5.8 score on a scale
Interval 0.0 to 36.0
|
SECONDARY outcome
Timeframe: Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reportedPopulation: Subjects assigned to Placebo or Rexulti who completed the study.
A self rated scale used to measure severity and change. The first 12 items of the scale are on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept them from getting things done. The lowest rating (1) means it caused little or no problems. Items 13-15 (positive behaviors) are rated according to frequency. Completed at every visit.
Outcome measures
| Measure |
Placebo
n=25 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=30 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Borderline Evaluation of Severity Over Time (BEST)
Visit 1
|
40.90 score on a scale
Standard Deviation 10.91
|
40.54 score on a scale
Standard Deviation 8.25
|
|
Borderline Evaluation of Severity Over Time (BEST)
Visit 8
|
29.15 score on a scale
Standard Deviation 8.37
|
23.15 score on a scale
Standard Deviation 9.06
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Week 12 (Visit 8)Population: Subjects who completed the study.
A self-report assessment of impulsivity that will be assessed at baseline and visit 8. The BIS is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale: (Rarely/Never = 1, Occasionally = 2, Often = 3, Almost Always/Always = 4). These scores are summed to produce an overall impulsivity score ranging from 30 (not impulsive) to 120 (extremely impulsive).
Outcome measures
| Measure |
Placebo
n=25 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=30 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Barratt Impulsiveness Scale (BIS)
Visit 1
|
76.53 score on a scale
Standard Deviation 15.33
|
72.27 score on a scale
Standard Deviation 15.50
|
|
Barratt Impulsiveness Scale (BIS)
Visit 8
|
68.13 score on a scale
Standard Deviation 13.89
|
70.5 score on a scale
Standard Deviation 17.86
|
SECONDARY outcome
Timeframe: Baseline, Visit 8 (Week 12)Population: Subjects who completed the study.
An instrument that helps evaluate a broad range of psychological problems and symptoms of Borderline Personality Disorder psychopathology. This will be assessed at baseline and visit 8.The 115 items are rated by using a 5-step Likert scale (0=not at all, 4=very strong) and provide a global picture of borderline psychopathology. Global scores of borderline psychopathology are calculated by summing 12 items and range from 0-48. Higher scores indicate more severe symptoms of Borderline Personality Disorder.
Outcome measures
| Measure |
Placebo
n=25 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=30 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Symptom Checklist-90 Revised
Visit 1
|
26.17 score on a scale
Standard Deviation 10.44
|
25.42 score on a scale
Standard Deviation 11.58
|
|
Symptom Checklist-90 Revised
Visit 8
|
20.25 score on a scale
Standard Deviation 7.99
|
14.21 score on a scale
Standard Deviation 10.88
|
SECONDARY outcome
Timeframe: assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to Week 12) is reportedPopulation: Subjects assigned to Placebo or Rexulti who completed the study.
A clinician-administered assessment of anxiety that will be assessed at all study visits (Visit 1-Visit 8). Changes in scores from baseline to final visit will be assessed. Higher scores (up to 56) indicate higher levels of anxiety, with 0 being no symptoms of anxiety.
Outcome measures
| Measure |
Placebo
n=25 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=30 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Hamilton Anxiety Rating Scale (HAM-A)
|
-2.41 change in score on a scale
Standard Deviation 8.43
|
-4.88 change in score on a scale
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reportedPopulation: Subjects assigned to placebo or Rexulti who completed the study
A clinician-administered assessment of depression that will be assessed at all study visits (Visits 1-8). Higher total scores indicate higher levels of depression (up to 52), while a score of 0 would indicate no depressive symptoms.
Outcome measures
| Measure |
Placebo
n=25 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=30 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D)
|
-2.09 change in score on a scale
Standard Deviation 6.91
|
-3.81 change in score on a scale
Standard Deviation 7.41
|
SECONDARY outcome
Timeframe: Baseline (Week 1)Population: Subjects who completed all baseline measures.
A short-structured interview that assesses comorbid psychiatric disorders according to the DSM 5 criteria. This assessment will be done during the baseline visit.
Outcome measures
| Measure |
Placebo
n=37 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=40 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
MINI International Neuropsychiatric Interview
Generalized Anxiety Disorder (Current)
|
10 Participants
|
15 Participants
|
|
MINI International Neuropsychiatric Interview
Antisocial Personality Disorder (Lifetime)
|
8 Participants
|
4 Participants
|
|
MINI International Neuropsychiatric Interview
ADHD Combined Type (Current)
|
2 Participants
|
4 Participants
|
|
MINI International Neuropsychiatric Interview
ADHD Inattentive Type (Current)
|
0 Participants
|
1 Participants
|
|
MINI International Neuropsychiatric Interview
ADHD Hyperactive Type (Current)
|
1 Participants
|
1 Participants
|
|
MINI International Neuropsychiatric Interview
Tourette's Syndrome (Lifetime)
|
0 Participants
|
1 Participants
|
|
MINI International Neuropsychiatric Interview
Persistent Motor Tic Disorder (Lifetime)
|
1 Participants
|
1 Participants
|
|
MINI International Neuropsychiatric Interview
Provisional Vocal Tic Disorder (Lifetime)
|
0 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Provisional Tic Disorder (Lifetime)
|
0 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Specific Phobia
|
4 Participants
|
1 Participants
|
|
MINI International Neuropsychiatric Interview
Body Dysmorphic Disorder (Current)
|
3 Participants
|
2 Participants
|
|
MINI International Neuropsychiatric Interview
Major Depressive Episode (Current)
|
16 Participants
|
18 Participants
|
|
MINI International Neuropsychiatric Interview
Major Depressive Episode (Past)
|
12 Participants
|
18 Participants
|
|
MINI International Neuropsychiatric Interview
Manic Episode (Current)
|
2 Participants
|
2 Participants
|
|
MINI International Neuropsychiatric Interview
Manic Episode (Past)
|
1 Participants
|
3 Participants
|
|
MINI International Neuropsychiatric Interview
Hypomanic Episode (Current)
|
1 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Bipolar I Disorder (Current)
|
0 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Bipolar I Disorder (Past)
|
0 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Bipolar II Disorder (Current)
|
0 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Bipolar II Disorder (Past)
|
0 Participants
|
1 Participants
|
|
MINI International Neuropsychiatric Interview
Panic Disorder (Current)
|
6 Participants
|
6 Participants
|
|
MINI International Neuropsychiatric Interview
Panic Disorder (Lifetime)
|
11 Participants
|
10 Participants
|
|
MINI International Neuropsychiatric Interview
Agoraphobia (Current)
|
7 Participants
|
9 Participants
|
|
MINI International Neuropsychiatric Interview
Social Anxiety Disorder (Current)
|
6 Participants
|
9 Participants
|
|
MINI International Neuropsychiatric Interview
Obsessive Compulsive Disorder (Current)
|
3 Participants
|
3 Participants
|
|
MINI International Neuropsychiatric Interview
Post Traumatic Stress Disorder (Current)
|
9 Participants
|
12 Participants
|
|
MINI International Neuropsychiatric Interview
Alcohol Use Disorder (Past 12 months)
|
13 Participants
|
8 Participants
|
|
MINI International Neuropsychiatric Interview
Substance Use Disorder (Past 12 months)
|
11 Participants
|
8 Participants
|
|
MINI International Neuropsychiatric Interview
Any Psychotic Disorder (Current)
|
0 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Any Psychotic Disorder (Lifetime)
|
0 Participants
|
1 Participants
|
|
MINI International Neuropsychiatric Interview
Major Depressive Disorder with Psychotic Features (Current)
|
0 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Major Depressive Disorder with Psychotic Features (Past)
|
0 Participants
|
0 Participants
|
|
MINI International Neuropsychiatric Interview
Anorexia Nervosa (current)
|
0 Participants
|
1 Participants
|
|
MINI International Neuropsychiatric Interview
Bulimia Nervosa (Current)
|
4 Participants
|
4 Participants
|
|
MINI International Neuropsychiatric Interview
Binge Eating Disorder (Current)
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8)Population: Subjects who completed at least one post-randomization visit
Subjects will complete the SDS at all visits. The change in scores from baseline to study completion will be assessed. The scale itself assesses the level of disability from borderline personality disorder (or target disorder) with higher scores indicating a more debilitating disorder. Scores range from 0-30.
Outcome measures
| Measure |
Placebo
n=34 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=35 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
Visit 6
|
11.2 score on a scale
Interval 0.0 to 30.0
|
7.9 score on a scale
Interval 0.0 to 30.0
|
|
Sheehan Disability Scale (SDS)
Visit 1
|
17.3 score on a scale
Interval 0.0 to 30.0
|
15.8 score on a scale
Interval 0.0 to 30.0
|
|
Sheehan Disability Scale (SDS)
Visit 2
|
13.3 score on a scale
Interval 0.0 to 30.0
|
10.7 score on a scale
Interval 0.0 to 30.0
|
|
Sheehan Disability Scale (SDS)
Visit 3
|
11.5 score on a scale
Interval 0.0 to 30.0
|
7.8 score on a scale
Interval 0.0 to 30.0
|
|
Sheehan Disability Scale (SDS)
Visit 4
|
12.4 score on a scale
Interval 0.0 to 30.0
|
7.8 score on a scale
Interval 0.0 to 30.0
|
|
Sheehan Disability Scale (SDS)
Visit 5
|
11.7 score on a scale
Interval 0.0 to 30.0
|
7.0 score on a scale
Interval 0.0 to 30.0
|
|
Sheehan Disability Scale (SDS)
Visit 7
|
12.0 score on a scale
Interval 0.0 to 30.0
|
6.9 score on a scale
Interval 0.0 to 30.0
|
|
Sheehan Disability Scale (SDS)
Visit 8
|
12.7 score on a scale
Interval 0.0 to 30.0
|
7.7 score on a scale
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: Baseline (Week 1), Week 12 (Visit 8)Population: Subjects who completed all visits.
A self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 8. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. Participants are asked to rate the importance of each domain on a 3-point scale ranging from 1=not important to 3=very important, and to rate how satisfied they are with that domain on a 6-point scale, ranging from -3=very dissatisfied to +3=very satisfied. In scoring, importance ratings are multiplied by satisfaction ratings to produce weighted satisfaction scores for each of the 16 domains. Weighted satisfaction scores are summed and divided by the number of domains that were rated as important or very important to produce a raw score, which is then converted to a t-score, which provides a proxy measurement for perceived quality of life. T-scores range from very low perceived quality of life (0-36) to high perceived quality of life (58-77).
Outcome measures
| Measure |
Placebo
n=25 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=30 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Quality of Life Inventory (QOLI)
Visit 1
|
28.89 score on a scale
Standard Deviation 9.11
|
28.70 score on a scale
Standard Deviation 11.18
|
|
Quality of Life Inventory (QOLI)
Visit 8
|
30.75 score on a scale
Standard Deviation 10.62
|
35.71 score on a scale
Standard Deviation 6.43
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), Week 12 (Visit 8)Population: Subjects who completed all baseline data
A self-report scale measuring suicidality. Subjects will complete the scale at all visits. Subjects are asked about suicidal thoughts. If answers are no, rater can proceed to "suicidal behavior" section where subject is asked about any non-suicidal self injurious behavior. If yes, subject is asked about intensity of ideations. In the event of serious threat to themselves, the subject will be escorted to the emergency room. Total score indicates severity of suicidal ideation and behavior, with lower scores representing lower levels of suicidality and higher scores representing higher levels of suicidality. A score of 0 would reflect no suicidality present, whereas a maximum score of 5 would reflect active suicidal ideation with intent to act.
Outcome measures
| Measure |
Placebo
n=40 Participants
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=40 Participants
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (CSSRS)
Visit 1
|
1.15 score on a scale
Standard Deviation 1.72
|
0.73 score on a scale
Standard Deviation 0.99
|
|
Columbia Suicide Severity Rating Scale (CSSRS)
Visit 8
|
0.23 score on a scale
Standard Deviation 0.66
|
0.08 score on a scale
Standard Deviation 0.35
|
Adverse Events
Placebo
Rexulti
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=40 participants at risk
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
2.5%
1/40 • Number of events 1 • Through study completion, an average of 12 weeks.
|
0.00%
0/40 • Through study completion, an average of 12 weeks.
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
1 milligram per day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Placebo: Pill that contains no medicine
|
Rexulti
n=40 participants at risk
1 milligram per day day for the first week and 1 milligram per day for the final taper week 2 milligrams per day for 10 weeks between taper periods.
Rexulti: Atypical antipsychotic
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.0%
6/40 • Through study completion, an average of 12 weeks.
|
5.0%
2/40 • Through study completion, an average of 12 weeks.
|
|
General disorders
Fatigue
|
10.0%
4/40 • Through study completion, an average of 12 weeks.
|
5.0%
2/40 • Through study completion, an average of 12 weeks.
|
|
General disorders
Restlessness
|
7.5%
3/40 • Through study completion, an average of 12 weeks.
|
7.5%
3/40 • Through study completion, an average of 12 weeks.
|
|
General disorders
Dry Mouth
|
0.00%
0/40 • Through study completion, an average of 12 weeks.
|
7.5%
3/40 • Through study completion, an average of 12 weeks.
|
|
General disorders
Headache
|
5.0%
2/40 • Through study completion, an average of 12 weeks.
|
2.5%
1/40 • Through study completion, an average of 12 weeks.
|
|
Psychiatric disorders
Hallucinations
|
5.0%
2/40 • Through study completion, an average of 12 weeks.
|
0.00%
0/40 • Through study completion, an average of 12 weeks.
|
|
General disorders
Sleep Problems
|
5.0%
2/40 • Through study completion, an average of 12 weeks.
|
0.00%
0/40 • Through study completion, an average of 12 weeks.
|
|
General disorders
Tremor
|
2.5%
1/40 • Through study completion, an average of 12 weeks.
|
0.00%
0/40 • Through study completion, an average of 12 weeks.
|
|
General disorders
Sweating
|
2.5%
1/40 • Through study completion, an average of 12 weeks.
|
0.00%
0/40 • Through study completion, an average of 12 weeks.
|
|
General disorders
Increase Appetite
|
2.5%
1/40 • Through study completion, an average of 12 weeks.
|
2.5%
1/40 • Through study completion, an average of 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place