Study Using Pregnenolone to Treat Bipolar Depression

• 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: University of Texas Southwestern Medical Center
• Collaborator: Stanley Medical Research Institute
• Information provided by (Responsible Party): Sherwood Brown, University of Texas Southwestern Medical Center

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
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: November 2011

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

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 122009-069
• First Posted: August 3, 2011
• 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; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Pathologic Processes; Mood Disorders; Mental Disorders; Bipolar and Related Disorders