RecruitingPhase 3ACTRN12606000253505

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

A pilot, double-blind crossover trial of the glucocorticoid antagonist mifepristone (RU-486) in the treatment of depression in patients with Parkinson's disease.


Sponsor

Neurological Foundation

Enrollment

20 participants

Start Date

Mar 27, 2006

Study Type

Interventional

Conditions

Summary

A crossover trial of mifepristone for the treatment of depression in Parkinson's disease. Participants will be randomly assigned to either mifepristone or placebo during the first part of the study and then assigned to the other during the second part of the study. The trial will be double blinded - the placebo and mifepristone are to be dispensed by a hospital pharmacy according to a code generated by a statistician. Participants and investigators will not know which has been dispensed until the completion of the trial.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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

Exclusion Criteria1

  • 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.

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Interventions

Mifepristone 600mg orally (3x200mg tablets) daily for 7 days.

Mifepristone 600mg orally (3x200mg tablets) daily for 7 days.


Locations(1)

Australia

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ACTRN12606000253505