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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000253505

Enrollment

Registered

2006-06-23

Start date

2006-03-27

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results