Phase 4
N=21
Brexpiprazole for Bipolar Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT03427892 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: The Montgomery-Asberg Depression Rating Scale (MADRS) — 31.95; 9.95; 10.95 score on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Brexpiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Montgomery-Asberg Depression Rating Scale (MADRS) |
31.95; 9.95; 10.95 | <.001 sig |
| SECONDARY Young Mania Rating Scale (YMRS) |
4.63; 4.21; 4.42 | .93 |
| SECONDARY Rey Auditoy Verbal Learning Test |
37.47; 37.79; 40.42; 39.74; 37.00; 39.26 | .49 |
| SECONDARY Stroop Task |
48.11; 41.21; 50.74; 49.89; 43.47; 51.79 | .221 |
| SECONDARY Trail Making Test (TMT) |
47.74; 51.16; 53.47; 45.79; 47.37; 49.68 | .07 |
| SECONDARY Systematic Assessment For Treatment Emergent Events |
49.79; 23.53; 23.42 | <.001 sig |
| SECONDARY Columbia Suicide Severity Rating Scale |
1.35; 0.00; 0.00; 0.10; 0.00; 0.00 | .022 sig |
| SECONDARY Abnormal Involuntary Movement Scale |
0.63; 1.26; 1.16 | .133 |
| SECONDARY Barnes Akathisia Scale |
0.12; 2.37; 2.47 | .002 sig |
| SECONDARY Simpson Angus Scale |
0.37; 1.16; 1.00 | .002 sig |
| SECONDARY Quality of Life in Bipolar Disorder (QOLBD) |
30.38; 40.95 | .005 sig |
| SECONDARY The Inventory of Depressive Symptomatology Self-Report (IDS-SR30) |
41.63; 18.95; 17.89 | <.001 sig |
Summary
The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an assessment of the following in patients with bipolar disorder taking brexpiprazole: manic symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life.
Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder, development of active suicidal or homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe life-threatening medical condition, involuntary psychiatric hospitalization or incarceration.
Eligibility Criteria
Inclusion Criteria
- Outpatient men and women ages 18-65
- Bipolar I or II disorders, currently depressed mood state based on a SCID for DSM-5; Mixed features in DSM-5 are allowed, but those with a Young Mania Rating Scale score ≥ 15 will be excluded
- Baseline MADRS score ≥ 20
Exclusion Criteria
- Mood disorders other than bipolar I or II disorders (e.g., bipolar NOS, or cyclothymic disorders, schizophrenia, schizoaffective disorder, or unipolar depression based on the SCID), other disorders, e.g. anxiety disorders, will be allowed
- Current (last 14 days) treatment with an antipsychotic or antidepressant
- History of neuroleptic malignant syndrome or tardive dyskinesia
- Prior history of brexpiprazole use
- Vulnerable populations (e.g., pregnant, nursing, cognitively impaired, incarcerated)
- High risk for suicide defined as > 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
- Severe or life-threatening medical condition, or laboratory or physical examination findings consistent with serious medical illness (e.g., dangerously abnormal electrolytes)
- Moderate or severe hepatic or renal impairment based on medical history and laboratory analyses
- Taking moderate or strong induces or inhibitors of CYP2D6 or CYP3A4
Data sourced from ClinicalTrials.gov (NCT03427892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.