Trial Review

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
ACTRN12606000253505
Ethics application status
Approved
Date submitted
23/03/2006
Date registered
23/06/2006
Date last updated
23/06/2006
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
Depression

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1440 0
Charities/Societies/Foundations
Name [1] 1440 0
Neurological Foundation
Country [1] 1440 0
Primary sponsor type
Charities/Societies/Foundations
Name
Neurological Foundation
Address
Country
New Zealand
Secondary sponsor category [1] 1274 0
None
Name [1] 1274 0
None
Address [1] 1274 0
Country [1] 1274 0

Ethics approval
Ethics application status
Approved
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
28/02/2005
Ethics approval number [1] 2815 0
URB/04/12/011

Summary
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

Contacts
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
Christchurch
Country 10137 0
New Zealand
Phone 10137 0
+64 3 3377969
Fax 10137 0
Email 10137 0
[email protected]
Contact person for scientific queries
Name 1065 0
Colin Peebles
Address 1065 0
Princess Margaret Hospital
Cashmere Road
PO Box 800
Christchurch
Country 1065 0
New Zealand
Phone 1065 0
+64 3 3377969
Fax 1065 0
Email 1065 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.