Status:
COMPLETED
Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 diso...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00223197
Start Date
February 1 2004
End Date
April 1 2006
Last Update
April 3 2012
Active Locations (1)
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1
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390