Study Using Pregnenolone to Treat Bipolar Depression

Major Depressive Disorder Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409096
• Other study ID #: 122009-069
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2011
• Last updated: March 1, 2016
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2016
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Pregnenolone
Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
• Placebo
Inactive ingredient matching the active medication in appearance.

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 17-item Hamilton Rating Scale for Depression (HRSD17)	The HRSD is an observer-rated measure of depressive symptomatology.; Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.	12 weeks
Secondary	Inventory of Depressive Symptomatology-Self Report (IDS-SR)	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	12 weeks
Secondary	Young Mania Rating Scale (YMRS)	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	12 weeks
Secondary	Hamilton Rating Scale for Anxiety (HRSA)	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.	12 weeks