Clinical trial NCT01409096: Study Using Pregnenolone to Treat Bipolar Depression
Official title: A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Major Depressive Disorder
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2011-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: The 17-item Hamilton Rating Scale for Depression (HRSD17)
timeFrame: 12 weeks
Secondary outcomes:
measure: Inventory of Depressive Symptomatology-Self Report (IDS-SR)
timeFrame: 12 weeks
measure: Young Mania Rating Scale (YMRS)
timeFrame: 12 weeks
measure: Hamilton Rating Scale for Anxiety (HRSA)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Edson S Brown, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: