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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called mifepristone can treat depression in people with Parkinson's disease. Depression affects many people with Parkinson's but is often hard to treat. Mifepristone works differently from typical antidepressants by blocking certain stress hormones. Participants will take the study drug and a dummy pill (placebo) in two separate periods, with neither the researchers nor the participants knowing which is which. You may be eligible if: - You have a confirmed diagnosis of Parkinson's disease - You have been diagnosed with a major depressive episode (by DSM-IV criteria) - Your memory and thinking score (MMSE) is above 23 - You are 18 years or older You may NOT be eligible if: - Your depression is severe with active thoughts of suicide requiring urgent treatment - You currently use steroid medications - You have severe asthma or other serious breathing problems - You have chronic adrenal, kidney, or liver failure - You are a woman of childbearing potential (women past menopause or post-surgical menopause are eligible) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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