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

NCT00223197 | Completed Phase 4

• 1 other identifier: 1103-714
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Major Depressive Disorder; Substance Abuse

Keywords

Bipolar with depression; Recurrent major depressive disorder; substance abuse dependence

Outcome Measures

Primary Outcomes (4)

• For the primary outcome measure, we will analyze both between group differences in change from baseline but also response rates.

• 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.

• All participants returning for at least one post baseline assessment will be used.

• In the case of early withdrawal from the study, the last visit will be used for the exit scores (last observation carried forward).

Interventions

Pregnenolone DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Substance-Related Disorders

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Sherwood Brown, M.D., Ph.D.

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2004
• Study Completion: April 1, 2006
• Last Updated: April 3, 2012

Record last verified: 2006-08

Locations

US (1)