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RU-486 in the Treatment of Bipolar Depression

NCT00359125 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-01-22

No results posted yet for this study

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).

Conditions

Interventions

DRUG

mifepristone (RU-486)

RU-486, 600 mg/day for 1 week.

OTHER

Placebo

Placebo, 600 mg/day for 1 week.

Sponsors & Collaborators

  • Western Economic Diversification Canada

    collaborator OTHER_GOV

  • Stanley Medical Research Institute

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Allan Young, MD · The University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00359125 on ClinicalTrials.gov