Status:
COMPLETED
Brexpiprazole for Bipolar Depression
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 brexpipr...
Detailed Description
We will conduct an 8-week, non-randomized, open label study of brexpiprazole in 20 persons with bipolar disorder. Primary Aim will be to determine if brexpiprazole is associated with a reduction in de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03427892
Start Date
March 1 2017
End Date
March 15 2018
Last Update
March 13 2019
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390