Study Using Pregnenolone to Treat Bipolar Depression
Major Depressive Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression|
- The 17-item Hamilton Rating Scale for Depression (HRSD17) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The HRSD is an observer-rated measure of depressive symptomatology.
Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.
- Inventory of Depressive Symptomatology-Self Report (IDS-SR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.
Minimum: 0 Maximum: 84 Lower score associated with better outcome
- Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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).
Minimum: 0 Maximum: 60 Lower score associated with better outcome
- Hamilton Rating Scale for Anxiety (HRSA) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
|Study Start Date:||March 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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.
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.
Inactive ingredient matching the active medication in appearance.
Other Name: Sugar pill
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409096
|United States, Texas|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Edson S Brown, MD/PhD||UT Southwestern Medical Center|