Study Using Pregnenolone to Treat Bipolar Depression

NCT01409096 | Completed Phase 4 Results DMC

• 1 other identifier: 122009-069
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• The 17-item Hamilton Rating Scale for Depression (HRSD17)

  The HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.

  12 weeks

Secondary Outcomes (3)

• Inventory of Depressive Symptomatology-Self Report (IDS-SR)

  12 weeks

• Young Mania Rating Scale (YMRS)

  12 weeks

• Hamilton Rating Scale for Anxiety (HRSA)

  12 weeks

Study Arms (2)

Pregnenolone

ACTIVE COMPARATOR

This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.

Drug: Pregnenolone

Placebo

PLACEBO COMPARATOR

The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.

Drug: Placebo

Interventions

Pregnenolone DRUG

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

Also known as: 3β-hydroxypregn-5-en-20-one

Pregnenolone

Placebo DRUG

Inactive ingredient matching the active medication in appearance.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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, 75235, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major

Interventions

Pregnenolone; Sugars

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder

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; Carbohydrates

Limitations and Caveats

Sample size; treatment groups not well matched on gender or depressive symptom scores

Results Point of Contact

• Title: E. Sherwood Brown, MD, PhD
• Organization: University of Texas Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

2146466948

Study Officials

• Edson S Brown, MD/PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 3, 2011
• Study Start: March 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 31, 2016
• Results First Posted: March 31, 2016

Record last verified: 2016-03

Locations

US (1)