The treatment of depression in Parkinson's Disease using mifepristone.

Phase 3

Recruiting

• Conditions: Diagnostic and Statistical Manual 4th edition (DSM-IV) Major Depressive Episode in patients with Parkinson's Disease.; Neurological - Parkinson's disease; Mental Health - Depression

• Registration Number: ACTRN12606000253505
• Lead Sponsor: eurological Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

PD (UK Brain Bank criteria), DSM-IV Major Depressive Episode, Mini-mental state examination (MMSE) score >23.

Exclusion Criteria

Depression complicated by active suicidal intent or requiring urgent treatment/hospitilisation, Current use steroid medications, Severe asthma/respiratory disease, Chronic adrenal, renal or hepatic failure, Females of child-bearing potential. Males and females eligible for study. Females of child-bearing potential are excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS)[At 2 weeks]

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS) [At 2 weeks.];Global Assessment of Functioning (GAF)[At 2 weeks.];Cognitive tests at 2 weeks (Hopkins Verbal Learning Test, Verbal fluency using letters FAS and equivalents, Digit span forwards and backwards, Benton Judgement of Line Orientation).[];Unified Parkinson's Disease Rating Scale (UPDRS) at completion of course of medication.[]