Study Using Pregnenolone to Treat Bipolar Depression

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The 17-item Hamilton Rating Scale for Depression (HRSD17)	12 weeks	The HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.

Secondary Outcome Measures

Name	Time	Method
Inventory of Depressive Symptomatology-Self Report (IDS-SR)	12 weeks	IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome
Young Mania Rating Scale (YMRS)	12 weeks	This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome
Hamilton Rating Scale for Anxiety (HRSA)	12 weeks	The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.