ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	28 February 2019
Main ID:	EUCTR2004-002608-13-GB
Date of registration:	19/04/2005
Prospective Registration:	Yes
Primary sponsor:	King’s College London & King’s College Hospital
Public title:	Pragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s disease
Scientific title:	Pragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s disease
Date of first enrolment:	16/05/2005
Target sample size:	60
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002608-13
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Clinically significant psychotic symptoms
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Identified treatable medical causes of psychosis; recent cerebrovascular disease; concurrent medications known to interact with quetiapine

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Parkinson's Disease with psychosis

Intervention(s)

Trade Name: Seroquel
Product Name: Seroquel
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Seroquel
Product Name: Seroquel
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To establish the efficacy of quetiapine in the treatment of psychosis in Parkinson's disease

Primary end point(s): Psychosis symptoms score; time remaining in the trial

Secondary Objective: To examine the adverse effects of quetiapine in this patient group

Secondary Outcome(s)

Secondary ID(s)

KCL/KCH-CT2004-1 (26/8/04)

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:	22/07/2018
Date Completed:	01/05/2007
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2004-002608-13/results

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.