Status:
COMPLETED
Study Using Pregnenolone to Treat Bipolar Depression
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explo...
Detailed Description
Determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase. In our pilot study, preg...
Eligibility Criteria
Inclusion
- Men and Women of all races age 18-75 years
- Diagnosis of bipolar I, II or not otherwise specified (NOS) disorders currently meeting criteria for a major depressive episode
- English speaking
Exclusion
- Active suicidal ideation with plan and intent
- Treatment resistant depression
- Vulnerable population (i.e. pregnant, cognitively impaired, incarcerated)
- Severe or life threatening medical condition
- History of allergic reaction or side effects with prior pregnenolone use
- Current substance use disorder defined as meeting criteria for abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual (DSM)(SCID) interview and self-reported use within the past 3 months or a positive baseline urine drug screen
- Removal or addition of concomitant psychiatric medications within 10 days prior to randomization
- Current Warfarin therapy
- Current use of oral contraceptives
- Current hormone replacement therapy
- History of heart disease or arrhythmias
- Current (past 7 days) systemic
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01409096
Start Date
March 1 2010
End Date
November 1 2011
Last Update
March 31 2016
Active Locations (1)
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1
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235