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Study Using Pregnenolone to Treat Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01409096
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

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

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

  1. 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.
  2. 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression
Study Start Date : March 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Pregnenolone
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
Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
Other Name: 3β-hydroxypregn-5-en-20-one
Placebo Comparator: Placebo
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Drug: Placebo
Inactive ingredient matching the active medication in appearance.
Other Name: Sugar pill


Outcome Measures

Primary Outcome Measures :
  1. The 17-item Hamilton Rating Scale for Depression (HRSD17) [ Time Frame: 12 weeks ]

    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 :
  1. Inventory of Depressive Symptomatology-Self Report (IDS-SR) [ Time Frame: 12 weeks ]

    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


  2. Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ]

    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


  3. Hamilton Rating Scale for Anxiety (HRSA) [ Time Frame: 12 weeks ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 3, 2011    Key Record Dates
Results First Posted: March 31, 2016
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders