PURPOSE: A 12-week trial adding pregnenolone therapy for bipolar patients to determine if pregnenolone supplementation is associated with improvement in depressive, anxiety, and or manic symptoms. We will also examine the relationship between serum pregnenolone levels producing a greater clinical response and the improvement of cognition.
PROJECT SUMMARY: The study is open to men and women between the ages of 18-75 years with symptoms of bipolar I, II, or NOS disorders currently experiencing a major depressive episode. If you decide to participate in this study you will take either pregnenolone or placebo (sugar pill) for 12 weeks. Participants who qualify will receive compensation at each study visit, incentive payments, and DART passes will be provided for each visit as needed.
BACKGROUND: Bipolar Disorder (BPD) is a severe and persistent psychiatric illness affecting 3.5% of the population. In addition to manic episodes, persons with BPD frequently experience depression. BPD is also frequently associated with memory impairment even when mood symptoms have resolved.
Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system. Although pregnenolone is a readily available, over-the-counter, nutritional supplement, research on its use in humans is quite limited.
Frequently Asked Questions
Q: If I use any type of street drugs will I be excluded from the study?
A: Persons who meet criteria for abuse or dependence within the past 3 months, or have a positive drug screen at the initial interview will be excluded.
Q: Will I qualify for the study if I do not have a diagnosis of bipolar disorder?
A: The researcher will perform a brief telephone interview to determine if person has symptoms of bipolar disorder. If enough symptoms are present at that time a formal psychiatric assessment is scheduled.
Q: Will my information be kept confidential?
A: Information that could identify individual subjects, including consent forms, will be maintained in locked filing cabinets or in computers with password protected access.
