ISRCTN ISRCTN74681449
DOI https://doi.org/10.1186/ISRCTN74681449
Secondary identifying numbers KCL/KCH-CT2004-1
Submission date
14/07/2005
Registration date
09/09/2005
Last edited
06/10/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymEQuiPP
Study objectivesThe 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) studiedParkinson's disease
InterventionQuetiapine versus Placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Quetiapine
Primary outcome measure1. 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 Remaining in the trial for the 12 week duration (patients will be withdrawn if their psychotic symptoms worsen)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 measures1. Activities of daily living
2. Cognitive function
3. Carer burden
Overall study start date01/08/2005
Completion date01/08/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2005
Date of final enrolment01/08/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

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

Website http://www.iop.kcl.ac.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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