Study Using Pregnenolone to Treat Bipolar Depression

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder; Bipolar Disorder

Treatments: Drug: Placebo; Drug: Pregnenolone

Study type: Interventional

Funder types: Other

Identifiers

NCT01409096

122009-069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Pregnenolone

Active Comparator group

Description:

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.

Treatment:

Drug: Pregnenolone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo