Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse
Completed · Phase 4
Conditions studied: Bipolar Disorder, Major Depressive Disorder, Substance Abuse
In brief
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.
Key facts
- Study ID
- NCT00223197
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 75
- Starts
- 2004-02-01
- Expected to finish
- 2006-04-01
- Last updated by the study team
- 2012-04-03
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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