Study Using Pregnenolone to Treat Bipolar Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Bipolar Disorder, Major Depressive Disorder

In brief

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 explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.

Key facts

Study ID

NCT01409096

Run by

University of Texas Southwestern Medical Center

People needed

80

Starts

2010-03-01

Expected to finish

2011-11-01

Last updated by the study team

2016-03-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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