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.
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.
Visit 1
Group
Value
95% CI
Placebo
18.2
8 – 36
Rexulti
17.6
8 – 36
Visit 2
Group
Value
95% CI
Placebo
12.8
0 – 36
Rexulti
10.9
0 – 36
Visit 3
Group
Value
95% CI
Placebo
10.7
0 – 36
Rexulti
7.9
0 – 36
Visit 4
Group
Value
95% CI
Placebo
10.7
0 – 36
Rexulti
8.0
0 – 36
Visit 5
Group
Value
95% CI
Placebo
9.7
0 – 36
Rexulti
7.0
0 – 36
Visit 6
Group
Value
95% CI
Placebo
9.6
0 – 36
Rexulti
6.6
0 – 36
Visit 7
Group
Value
95% CI
Placebo
8.7
0 – 36
Rexulti
6.0
0 – 36
Visit 8
Group
Value
95% CI
Placebo
9.3
0 – 36
Rexulti
5.8
0 – 36
Borderline Evaluation of Severity Over Time (BEST)Secondary· Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reported
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.
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).
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.
Visit 1
Group
Value
95% CI
Placebo
26.17
± 10.44
Rexulti
25.42
± 11.58
Visit 8
Group
Value
95% CI
Placebo
20.25
± 7.99
Rexulti
14.21
± 10.88
Hamilton Anxiety Rating Scale (HAM-A)Secondary· assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to Week 12) is reported
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.
Group
Value
95% CI
Placebo
-2.41
± 8.43
Rexulti
-4.88
± 7.46
Hamilton Depression Rating Scale (HAM-D)Secondary· Assessed at Visits 1 to 8, change in scores from Visit 1 to Visit 8 (baseline to week 12) is reported
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.
Group
Value
95% CI
Placebo
-2.09
± 6.91
Rexulti
-3.81
± 7.41
MINI International Neuropsychiatric InterviewSecondary· Baseline (Week 1)
A short-structured interview that assesses comorbid psychiatric disorders according to the DSM 5 criteria. This assessment will be done during the baseline 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.
Visit 1
Group
Value
95% CI
Placebo
17.3
0 – 30
Rexulti
15.8
0 – 30
Visit 2
Group
Value
95% CI
Placebo
13.3
0 – 30
Rexulti
10.7
0 – 30
Visit 3
Group
Value
95% CI
Placebo
11.5
0 – 30
Rexulti
7.8
0 – 30
Visit 4
Group
Value
95% CI
Placebo
12.4
0 – 30
Rexulti
7.8
0 – 30
Visit 5
Group
Value
95% CI
Placebo
11.7
0 – 30
Rexulti
7.0
0 – 30
Visit 6
Group
Value
95% CI
Placebo
11.2
0 – 30
Rexulti
7.9
0 – 30
Visit 7
Group
Value
95% CI
Placebo
12.0
0 – 30
Rexulti
6.9
0 – 30
Visit 8
Group
Value
95% CI
Placebo
12.7
0 – 30
Rexulti
7.7
0 – 30
Quality of Life Inventory (QOLI)Secondary· Baseline (Week 1), Week 12 (Visit 8)
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
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
Visit 1
Group
Value
95% CI
Placebo
1.15
± 1.72
Rexulti
0.73
± 0.99
Visit 8
Group
Value
95% CI
Placebo
0.23
± 0.66
Rexulti
0.08
± 0.35
Adverse events — posted to ClinicalTrials.gov
Time frame: Through study completion, an average of 12 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07001475 — A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperact
· Phase 1
· recruiting
NCT07119541 — Testing an Alliance-Focused Dialectical Behaviour Therapy Training for Borderline Personality Disorder
· NA
· active not recruiting
NCT06446765 — Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
· Phase 2
· recruiting
NCT07197502 — Treatment of Borderline Personality Disorder With rTMS
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Chicago
Last refreshed: 18 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03418675.