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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 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Pregnenolone

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2010-03
Est. Completion 2011-11
Phase Phase 4

What the Registry Record Tells You About NCT01409096

The ClinicalTrials.gov registry entry for NCT01409096 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01409096 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.