CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Pregnenolone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01409096
NCT01409096Phase 4Completed
CompareCT.gov

A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression

University of Texas Southwestern Medical Center·interventional·Posted Aug 3, 2011·Updated Mar 31, 2016

In Brief

A Phase 4 clinical trial evaluating Pregnenolone and Placebo for Bipolar Disorder and Major Depressive Disorder. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Major Depressive Disorder
CountriesUnited States
CollaboratorsStanley Medical Research Institute

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 3, 2011
Enrollment StartMar 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.9 years ago

Interventions

Pregnenolonedrug

Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.

Placebodrug

Inactive ingredient matching the active medication in appearance.