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

NCT ID: NCT00223197

Last Updated: 2012-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-04-30

Brief 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.

Detailed 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.

Conditions

Bipolar Disorder; Major Depressive Disorder; Substance Abuse

Study Design

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

Interventions

Pregnenolone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

Principal Investigators

Sherwood Brown, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center at Dallas

Locations

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

1103-714

Identifier Type: -

Identifier Source: org_study_id