Major Depressive Disorder Clinical Trial
Official title:
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.
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.
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