Condition category
Nervous System Diseases
Date applied
14/07/2005
Date assigned
09/09/2005
Last edited
06/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anthony David

ORCID ID

Contact details

Institute of Psychiatry
P.O. Box 68
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)207 848 0138
A.David@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KCL/KCH-CT2004-1

Study information

Scientific title

Acronym

EQuiPP

Study hypothesis

The study hypothesis is that Quetiapine is effective in the treatment of the psychotic symptoms (hallucinations/delusions) seen in Parkinson's disease

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Parkinson's disease

Intervention

Quetiapine versus Placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Quetiapine

Primary outcome measures

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 Remaining in the trial for the 12 week duration (patients will be withdrawn if their psychotic symptoms worsen)

Secondary outcome measures

1. Activities of daily living
2. Cognitive function
3. Carer burden

Overall trial start date

01/08/2005

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/08/2005

Recruitment end date

01/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Gill Dale
P.O. Box 005
The Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Parkinson's Disease Society (UK) (Ref: 4052)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19557142

Publication citations

  1. Results

    Shotbolt P, Samuel M, Fox C, David AS, A randomized controlled trial of quetiapine for psychosis in Parkinson's disease., Neuropsychiatr Dis Treat, 2009, 5, 327-332.

Additional files

Editorial Notes