We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The treatment of depression in Parkinson's Disease using mifepristone.
Scientific title
A pilot, double-blind crossover trial of the glucocorticoid antagonist mifepristone (RU-486) in the treatment of depression in patients with Parkinson's disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diagnostic and Statistical Manual 4th edition (DSM-IV) Major Depressive Episode in patients with Parkinson's Disease. 1231 0
Condition category
Condition code
Neurological 1314 1314 0 0
Parkinson's disease
Mental Health 1315 1315 0 0

Study type
Description of intervention(s) / exposure
Mifepristone 600mg orally (3x200mg tablets) daily for 7 days.
Intervention code [1] 948 0
Treatment: Drugs
Comparator / control treatment
Placebo (3 identical tablets) orally daily for 7 days .
Control group

Primary outcome [1] 1797 0
Montgomery Asberg Depression Rating Scale (MADRS)
Timepoint [1] 1797 0
At 2 weeks
Secondary outcome [1] 3151 0
Hamilton Depression Rating Scale (HDRS)
Timepoint [1] 3151 0
At 2 weeks.
Secondary outcome [2] 3152 0
Global Assessment of Functioning (GAF)
Timepoint [2] 3152 0
At 2 weeks.
Secondary outcome [3] 3153 0
Cognitive tests at 2 weeks (Hopkins Verbal Learning Test, Verbal fluency using letters "F""A""S" and equivalents, Digit span forwards and backwards, Benton Judgement of Line Orientation).
Timepoint [3] 3153 0
Secondary outcome [4] 3154 0
Unified Parkinson's Disease Rating Scale (UPDRS) at completion of course of medication.
Timepoint [4] 3154 0

Key inclusion criteria
PD (UK Brain Bank criteria), DSM-IV Major Depressive Episode, Mini-mental state examination (MMSE) score >23.
Minimum age
18 Years
Maximum age
Not stated
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation code will be held only by the pharmacist and the placebo tablets used will be identical to the mifepristone tablets. All medication will be dispensed by one hospital pharmacy. A statistician will generate the randomisation code and give this to the pharmacist but not the investigators. The investigators will give participants a standard presciption form to take to the pharmacy which will be the same regardless of whether mifepristone or placebo will be dispensed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Intervention order (mifepristone versus placebo) determined by computerised method using Microsoft Excel random number generator and balanced in blocks. Block sizes not variable.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1440 0
Name [1] 1440 0
Neurological Foundation
Address [1] 1440 0
Country [1] 1440 0
Primary sponsor type
Neurological Foundation
New Zealand
Secondary sponsor category [1] 1274 0
Name [1] 1274 0
Address [1] 1274 0
Country [1] 1274 0

Ethics approval
Ethics application status
Ethics committee name [1] 2815 0
Upper South B ethics committee -Christchurch
Ethics committee address [1] 2815 0
Ethics committee country [1] 2815 0
New Zealand
Date submitted for ethics approval [1] 2815 0
Approval date [1] 2815 0
Ethics approval number [1] 2815 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35128 0
Address 35128 0
Country 35128 0
Phone 35128 0
Fax 35128 0
Email 35128 0
Contact person for public queries
Name 10137 0
Colin Peebles
Address 10137 0
Princess Margaret Hospital
Cashmere Road
PO Box 800
Country 10137 0
New Zealand
Phone 10137 0
+64 3 3377969
Fax 10137 0
Email 10137 0
Contact person for scientific queries
Name 1065 0
Colin Peebles
Address 1065 0
Princess Margaret Hospital
Cashmere Road
PO Box 800
Country 1065 0
New Zealand
Phone 1065 0
+64 3 3377969
Fax 1065 0
Email 1065 0

No information has been provided regarding IPD availability
Summary results
No Results