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NCT01409096 · ClinicalTrials.gov registry record · Phase 4
Study Using Pregnenolone to Treat Bipolar Depression
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT01409096: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT01409096 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01409096, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.
Primary Outcome
The HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.
Interventions
- DRUG Placebo
- DRUG Pregnenolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-11 |
| Phase | Phase 4 |
What the finished NCT01409096 record still lists
NCT01409096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01409096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01409096 about?
NCT01409096 is a clinical study titled "Study Using Pregnenolone to Treat Bipolar Depression". Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.
What is the current status of trial NCT01409096?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2010-03. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01409096?
The interventions under investigation include: Placebo (DRUG), Pregnenolone (DRUG).
Who is sponsoring clinical trial NCT01409096?
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 NCT01409096's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 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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