Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse
|ClinicalTrials.gov Identifier: NCT00223197|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Major Depressive Disorder Substance Abuse||Drug: Pregnenolone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||February 2004|
|Estimated Study Completion Date :||April 2006|
- For the primary outcome measure, we will analyze both between group differences in change from baseline but also response rates.
- 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.
- All participants returning for at least one post baseline assessment will be used.
- In the case of early withdrawal from the study, the last visit will be used for the exit scores (last observation carried forward).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223197
|United States, Texas|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Sherwood Brown, M.D., Ph.D.||UT Southwestern Medical Center at Dallas|