search
Back to results

Study Using Pregnenolone to Treat Bipolar Depression

Primary Purpose

Bipolar Disorder, Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregnenolone
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pregnenolone

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Inventory of Depressive Symptomatology-Self Report (IDS-SR)
IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome
Young Mania Rating Scale (YMRS)
This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome
Hamilton Rating Scale for Anxiety (HRSA)
The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Full Information

First Posted
August 2, 2011
Last Updated
March 1, 2016
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Stanley Medical Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01409096
Brief Title
Study Using Pregnenolone to Treat Bipolar Depression
Official Title
A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase. In our pilot study, pregnenolone showed a strong signal on depression scores. Secondary Determine if pregnenolone supplementation is associated with greater improvement in anxiety symptoms in persons with BPD, depressed phase. Data from prior studies suggests that pregnenolone may decrease symptoms of anxiety. Anxiety is a common and clinically important feature of BPD. Therefore, we will examine anxiety symptoms in this trial. Determine if pregnenolone supplementation is associated with improvement in manic symptoms as compared to placebo in persons with BPD, depressed phase. Our pilot study suggested that pregnenolone may be associated with improvement in manic symptoms. Although the current study targets bipolar depression we will also examine manic symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregnenolone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Pregnenolone
Other Intervention Name(s)
3β-hydroxypregn-5-en-20-one
Intervention Description
Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Inactive ingredient matching the active medication in appearance.
Primary Outcome Measure Information:
Title
The 17-item Hamilton Rating Scale for Depression (HRSD17)
Description
The HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Description
IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome
Time Frame
12 weeks
Title
Young Mania Rating Scale (YMRS)
Description
This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome
Time Frame
12 weeks
Title
Hamilton Rating Scale for Anxiety (HRSA)
Description
The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edson S Brown, MD/PhD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study Using Pregnenolone to Treat Bipolar Depression

We'll reach out to this number within 24 hrs