Overview

RU-486 in the Treatment of Bipolar Depression

Status:
Withdrawn
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
Bipolar disorder is a chronic and recurrent illness which involves episodes of mania and depression. It is believed that disturbance of the stress hormone system (the hypothalamic-pituitary-adrenal or HPA axis) may cause thinking and memory problems and make the depressive symptoms worse in bipolar disorder. Early studies have shown that mifepristone may have antidepressant effects (may improve the symptoms of depression) and may also maintain or enhance cognition (memory and thinking functions). The purpose of this study is to determine the potential therapeutic efficacy (usefulness) of mifepristone in bipolar depression by assessing the effects of the medication on depressive symptoms and on cognition. This will be done by questionnaires and thinking tests. This study will also try to clarify the functional changes that accompany bipolar disorder by analyzing saliva samples (assessing the stress response by measuring the levels of 2 stress hormones: cortisol and DHEA).
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of British Columbia
Collaborators:
Stanley Medical Research Institute
Western Economic Diversification Canada
Treatments:
Mifepristone
Criteria
Inclusion Criteria:

Male & female outpatients between 19-65 years of age with a diagnosis of bipolar
depression. Women must not be currently pregnant and must use a reliable method of
contraception for the duration of the study. Subjects must be on stable medication (4 weeks
minimum) for their bipolar illness. Subjects must be able to provide written informed
consent. Subjects must adequately understand written & verbal English as rating scales as
neurocognitive tests are only in English.

Exclusion Criteria:

Those not meeting the above criteria and those not competent to give informed consent.
Women who are currently pregnant. Also excluded: those who have a clinically significant
medical illness (including significant head injury with loss of consciousness), those at
immediate risk of harming self or others, are currently abusing alcohol or drugs, those
with a neurological disorder or uncompensated endocrine disorder, those with a known
allergy to mifepristone, those currently being treated with an investigational medication
or medication that is contraindicated with mifepristone.