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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

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