Study Using Pregnenolone to Treat Bipolar Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD), Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/14/2017 |
| Start Date: | March 2010 |
| End Date: | November 2011 |
A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression
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.
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.
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.
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.
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
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