RU-486 in the Treatment of Bipolar Depression

NCT00359125 | Withdrawn Phase 2

• 2 other identifiers: C06-0327H06-0093
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Bipolar Depression

Keywords

bipolar; RU-486; mifepristone; neurocognition; mood; cortisol; HPA axis

Outcome Measures

Primary Outcomes (1)

• Neurocognitive performance at weeks -1, 3 & 8 and symptom change at weeks -2, -1, 0, 1, 2, 3, 4, 5 & 8

Secondary Outcomes (1)

• HPA axis functioning from saliva samples at weeks -2, -1, 2, 3 & 8

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: mifepristone (RU-486)

2

PLACEBO COMPARATOR

Placebo, 600 mg/day for 1 week

Other: Placebo

Interventions

mifepristone (RU-486) DRUG

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

Also known as: Mifepristone

1

Placebo OTHER

Placebo, 600 mg/day for 1 week.

2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Western Economic Diversification Canada: collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (1)

University of British Columbia, Dept. of Psychiatry

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Allan Young, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: July 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

CA (1)