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Study Using Pregnenolone to Treat Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01409096
First received: August 2, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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. Safety and tolerability of 500 mg/day of pregnenolone will be looked at and patient's serum pregnenolone levels will be checked.


Condition Intervention Phase
Bipolar Disorder
Major Depressive Disorder
 Drug: Pregnenolone
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • The 17-item Hamilton Rating Scale for Depression (HRSD17) [ Time Frame: Bi-weekly 12 weeks ] [ Designated as safety issue: No ]
    an observer-rated measure of depressive symptomatology


Enrollment: 80
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pregnenolone
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Quetiapine twice per day for 2 weeks, then 250mg Quetiapine twice per day for 8 weeks.
 Drug: Pregnenolone
Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
Placebo Comparator: Placebo
The arm will be given placebo that matches the Quetiapine at the same frequency as the Quetiapine for 12 weeks.
 Drug: Placebo
Inactive ingredient matching the active medication in appearance.
Other Name: Sugar pill

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and Women of all races age 18-75 years
  • Diagnosis of bipolar I, II or not otherwise specified (NOS) disorders currently meeting criteria for a major depressive episode
  • English speaking

Exclusion Criteria:

  • Active suicidal ideation with plan and intent
  • Treatment resistant depression
  • Vulnerable population (i.e. pregnant, cognitively impaired, incarcerated)
  • Severe or life threatening medical condition
  • History of allergic reaction or side effects with prior pregnenolone use
  • Current substance use disorder defined as meeting criteria for abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual (DSM)(SCID) interview and self-reported use within the past 3 months or a positive baseline urine drug screen
  • Removal or addition of concomitant psychiatric medications within 10 days prior to randomization
  • Current Warfarin therapy
  • Current use of oral contraceptives
  • Current hormone replacement therapy
  • History of heart disease or arrhythmias
  • Current (past 7 days) systemic
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409096

Locations
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Edson S Brown, MD/PhD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Sherwood Brown, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01409096     History of Changes
Other Study ID Numbers: 122009-069
Study First Received: August 2, 2011
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
 Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013