Efficacy of mifepristone in the treatment of bipolar depressio

Completed

• Conditions: Bipolar Depression; Mental and Behavioural Disorders; Bipolar depression

• Registration Number: ISRCTN27649427
• Lead Sponsor: The Newcastle, North Tyneside And Northumberland Mental Health NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Bipolar Depression (Structured Clinical Interview for Depression [SCID])
2. Age 18-65

Exclusion Criteria

1. SCID diagnosis of mixed episode
2. Change in medication over the past 4 weeks
3. History of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
4. Alcohol dependence (within the last 12 months)
5. Current alcohol or substance abuse (within the last month)
6. Previous head-injury associated with loss of consciousness
7. Pregnant
8. Intending to become pregnant
9. Women not using adequate contraception
10. Neurological disorder
11. Endocrine disorder other than corrected hypothyroidism
12. Steroid medication
13. Significant physical health problem
14. Contraindication to study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Spatial Working Memory (CANTAB) <br>2. Verbal learning

Secondary Outcome Measures

Name	Time	Method
A secondary neuropsychological battery will also be included which examines a broader range of neurocognitive domains, incorporating: short-term memory span, visuo-spatial learning and memory, executive function, attention, semantic memory and perception of facial expression of emotion. In addition, depressive symptoms measured with the Montgomery and Asberg Depression Rating Scale (MADRS) will also act as secondary outcome measure.