Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse

Major Depressive Disorder Clinical Trial

Official title:

A Double-blind Placebo Controlled Trial of Pregnenolone for Depression in Patients With Bipolar Disorders or Recurrent Major Depressive Disorder and a History of Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223197
• Other study ID #: 1103-714
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: April 2, 2012
• Start date: February 2004
• Est. completion date: April 2006

Study information

• Verified date: August 2006
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to determine if pregnenolone supplement is associated with a reduction in substance use and craving in patients with recurrent major depressive disorder or bipolar disorder and substance abuse/dependence. This research also wants to explore if pregnenolone supplements are associated with improvement in psychiatric symptoms and memory, which are often negatively affected in these patients. It is hypothesized that patients receiving pregnenolone supplements would show greater improvements in mood symptoms and memory, and crave substances less than the patients receiving placebo.

Description:

Seventy five - (75) outpatients meeting the inclusion and exclusion criteria will be enrolled after completing an IRB-approved informed consent process. Baseline evaluation will include a medical and psychiatric history, structured clinical interview for DSM-IV (SCID), mood assessment with the Hamilton Rating Scale for Depression (HRSD, 17-item version), Inventory of Depressive Symptomatology-Self Report (IDS-SR) (Rush et al., 1996), Hamilton Rating Scale for Anxiety (HRSA), Young Mania Rating Scale (YMRS), and, and cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT), Stroop Test Color Trails, Wechsler Test of Adult Reading and the Brief Visual Memory Test-Revised (BVMT-R) will be performed. Substance use (days/week) of use, urine drug screens and time to relapse will be monitored. Craving for substances will be monitored with visual analogue scales. Pregnenolone or placebo will be initiated at one capsule/day (50 mg/d if active medication). Pregnenolone and the placebo will be obtained from Abrams Pharmacy, which has ensured the potency (the supplier uses GMP pharmaceutical standards). Participants will return for reassessment every 2 weeks for 8 weeks with the HRSD, IDS-SR, YMRS, ISS, and a neurocognitive battery (e.g. RAVLT, Stroop Test and Trails B). Side effects will be monitored with the PRD-III Somatic Symptom Scale (Thase et al., 1996). At week 4 subjects who not having significant side effects and have not had a 50% reduction in HRSD scores will have the dosage increased to two capsules per day (100 mg/d if active medication). Participants will be paid $30 at weeks 2, 4, and 8. Participants who respond favorably will, at completion, have the option of continuing this over-the-counter supplement if they so choose with their physician's knowledge and approval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• English speaking

• Diagnosis of Bipolar I, II, NOS or recurrent major depressive disorder

• Bipolar I patients must be receiving a mood stabilizer

• History of substance-related disorder with no substance use within 14 days of beginning the study

Exclusion Criteria:

• Currently suicidal or homicidal (within 4 weeks of study enrollment)

• Severe or life-threatening medical illness

• Pregnant or nursing female

• Current pregnenolone therapy or allergies to pregnenolone

• Member of vulnerable population (prisoner, demented, mental retardation)

• Participants with treatment resistant depression

• Actively psychotic within 2 months prior to enrollment;

• A change in antipsychotic medication 1 month prior to enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Recurrence
• Substance Abuse
• Substance-Related Disorders

Intervention

Drug:
• Pregnenolone

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	For the primary outcome measure, we will analyze both between group differences in change from baseline but also response rates.
Primary	Paired T tests will be used to compare outcome measures of HRSD, IDS-SR, HRSA, YMRS, RAVLT, Stroop, Trails B, and PRD III from baseline to exit.
Primary	All participants returning for at least one post baseline assessment will be used.
Primary	In the case of early withdrawal from the study, the last visit will be used for the exit scores (last observation carried forward).