Efficacy of Quetiapine in Parkinson's Psychosis

ISRCTN	ISRCTN74681449
DOI	https://doi.org/10.1186/ISRCTN74681449
Protocol serial number	KCL/KCH-CT2004-1
Sponsor	King's College London (UK)
Funder	Parkinson's Disease Society (UK) (Ref: 4052)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Anthony David
Scientific

Institute of Psychiatry
P.O. Box 68
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Phone	+44 (0)207 848 0138
Email	A.David@iop.kcl.ac.uk

Primary study design	Interventional
Study design	Randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EQuiPP
Study objectives	The study hypothesis is that Quetiapine is effective in the treatment of the psychotic symptoms (hallucinations/delusions) seen in Parkinson's disease
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Parkinson's disease
Intervention	Quetiapine versus Placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Quetiapine
Primary outcome measure(s)	1. Improvment in psychotic symptoms 2. Parkinsonian symptoms 3. Depressive symptoms 4. Remaining in the trial for the 12 week duration (patients will be withdrawn if their psychotic symptoms worsen)
Key secondary outcome measure(s)	1. Activities of daily living 2. Cognitive function 3. Carer burden
Completion date	01/08/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Hallucinations, delusions of a severity >3/7 on the Brief Psychiatric Rating Scale, 2. Diagnosis of Parkinson's which meets UKPD Society Brain Bank criteria
Key exclusion criteria	1. Anti-psychotic medication in the preceding 3 months 2. Any contra-indication to quetiapine 3. Any important drug interactions 4. Major concomitant medical illness 5. History of uncontrolled diabetes or hypertension 6. Changes in medication in the last 14 days
Date of first enrolment	01/08/2005
Date of final enrolment	01/08/2006

Institute of Psychiatry

London
SE5 8AF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009		Yes	No