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Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00223197
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 3, 2012
Stanley Medical Research Institute
Information provided by:
University of Texas Southwestern Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Major Depressive Disorder Substance Abuse Drug: Pregnenolone Phase 4

Detailed Description:
Seventy five - (75) outpatients meeting the inclusion and exclusion criteria will be enrolled after completing an IRB-approved informed consent process. Baseline evaluation will include a medical and psychiatric history, structured clinical interview for DSM-IV (SCID), mood assessment with the Hamilton Rating Scale for Depression (HRSD, 17-item version), Inventory of Depressive Symptomatology-Self Report (IDS-SR) (Rush et al., 1996), Hamilton Rating Scale for Anxiety (HRSA), Young Mania Rating Scale (YMRS), and, and cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT), Stroop Test Color Trails, Wechsler Test of Adult Reading and the Brief Visual Memory Test-Revised (BVMT-R) will be performed. Substance use (days/week) of use, urine drug screens and time to relapse will be monitored. Craving for substances will be monitored with visual analogue scales. Pregnenolone or placebo will be initiated at one capsule/day (50 mg/d if active medication). Pregnenolone and the placebo will be obtained from Abrams Pharmacy, which has ensured the potency (the supplier uses GMP pharmaceutical standards). Participants will return for reassessment every 2 weeks for 8 weeks with the HRSD, IDS-SR, YMRS, ISS, and a neurocognitive battery (e.g. RAVLT, Stroop Test and Trails B). Side effects will be monitored with the PRD-III Somatic Symptom Scale (Thase et al., 1996). At week 4 subjects who not having significant side effects and have not had a 50% reduction in HRSD scores will have the dosage increased to two capsules per day (100 mg/d if active medication). Participants will be paid $30 at weeks 2, 4, and 8. Participants who respond favorably will, at completion, have the option of continuing this over-the-counter supplement if they so choose with their physician's knowledge and approval.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind Placebo Controlled Trial of Pregnenolone for Depression in Patients With Bipolar Disorders or Recurrent Major Depressive Disorder and a History of Substance Abuse
Study Start Date : February 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Primary Outcome Measures :
  1. For the primary outcome measure, we will analyze both between group differences in change from baseline but also response rates.
  2. Paired T tests will be used to compare outcome measures of HRSD, IDS-SR, HRSA, YMRS, RAVLT, Stroop, Trails B, and PRD III from baseline to exit.
  3. All participants returning for at least one post baseline assessment will be used.
  4. In the case of early withdrawal from the study, the last visit will be used for the exit scores (last observation carried forward).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • English speaking
  • Diagnosis of Bipolar I, II, NOS or recurrent major depressive disorder
  • Bipolar I patients must be receiving a mood stabilizer
  • History of substance-related disorder with no substance use within 14 days of beginning the study

Exclusion Criteria:

  • Currently suicidal or homicidal (within 4 weeks of study enrollment)
  • Severe or life-threatening medical illness
  • Pregnant or nursing female
  • Current pregnenolone therapy or allergies to pregnenolone
  • Member of vulnerable population (prisoner, demented, mental retardation)
  • Participants with treatment resistant depression
  • Actively psychotic within 2 months prior to enrollment;
  • A change in antipsychotic medication 1 month prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00223197

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United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
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Principal Investigator: Sherwood Brown, M.D., Ph.D. UT Southwestern Medical Center at Dallas
Layout table for additonal information Identifier: NCT00223197    
Other Study ID Numbers: 1103-714
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: August 2006
Keywords provided by University of Texas Southwestern Medical Center:
Bipolar with depression
Recurrent major depressive disorder
substance abuse dependence
Additional relevant MeSH terms:
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Substance-Related Disorders
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Chemically-Induced Disorders
Disease Attributes