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NCT00223197 · ClinicalTrials.gov registry record · Phase 4
Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
NCT00223197: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT00223197 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 75 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00223197, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
Study 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.
Interventions
- DRUG Pregnenolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-02 |
| Est. Completion | 2006-04 |
| Phase | Phase 4 |
What the finished NCT00223197 record still lists
NCT00223197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Pregnenolone is the first listed.
NCT00223197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00223197 about?
NCT00223197 is a clinical study titled "Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse". 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...
What is the current status of trial NCT00223197?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2004-02. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00223197?
The interventions under investigation include: Pregnenolone (DRUG).
Who is sponsoring clinical trial NCT00223197?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00223197's enrollment target sits among peer trials
75 1002nd of 2000 higher than 974 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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