Study Using Pregnenolone to Treat Bipolar Depression

NCT ID: NCT01409096

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-11-30

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

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, pregnenolone showed a strong signal on depression scores.

Secondary

1. Determine if pregnenolone supplementation is associated with greater improvement in anxiety symptoms in persons with BPD, depressed phase. Data from prior studies suggests that pregnenolone may decrease symptoms of anxiety. Anxiety is a common and clinically important feature of BPD. Therefore, we will examine anxiety symptoms in this trial.

2. Determine if pregnenolone supplementation is associated with improvement in manic symptoms as compared to placebo in persons with BPD, depressed phase. Our pilot study suggested that pregnenolone may be associated with improvement in manic symptoms. Although the current study targets bipolar depression we will also examine manic symptoms.

Conditions

Bipolar Disorder; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pregnenolone

This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Pregnenolone

Intervention Type: DRUG

Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.

Placebo

The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive ingredient matching the active medication in appearance.

Interventions

Pregnenolone

Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.

Intervention Type: DRUG

Placebo

Inactive ingredient matching the active medication in appearance.

Intervention Type: DRUG

Other Intervention Names

3β-hydroxypregn-5-en-20-one; Sugar pill

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherwood Brown

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edson S Brown, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

122009-069

Identifier Type: -

Identifier Source: org_study_id