Subjective well-being, craving for Cannabis and compliance or medication switch in a randomised double blind study with Olanzapine and Risperidone

ISRCTN	ISRCTN46365995
DOI	https://doi.org/10.1186/ISRCTN46365995
Protocol serial number	NTR28
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Eli Lilly (The Netherlands)

Submission date: 16/05/2005
Registration date: 16/05/2005
Last edited: 07/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lonneke van Nimwegen
Scientific

Academic Medical Centre
University of Amsterdam
Adolescent Clinic
Department of Psychiatry
Tafelbergweg 25
Amsterdam
1105 BC
Netherlands

Phone	+31 (0)20 566 2142
Email	L.J.vanNimwegen@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group, double-blinded trial
Secondary study design	Randomised controlled trial
Scientific title	Subjective well-being, craving for Cannabis and compliance or medication switch in a randomised double blind study with Olanzapine and Risperidone
Study acronym	SUB.CAN.OLA.RIS
Study objectives	Not provided at time of registration
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Schizophrenia, schizo-affective disorder, schizofreniform disorder
Intervention	Patients are treated double blind with olanzapine (5 - 20 mg) or risperidone (1.25 - 5 mg) for six weeks. At t = 0, t = 7 days and t = 42 days, questionnaires are taken and after six weeks the medication is disclosed. The physician and patient decide if this neuroleptic will be continued. After one year the questionnaires are taken once more.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Olanzapine and risperidone
Primary outcome measure(s)	1. Subjective Well-Being Under Neuroleptics Scale (SWN) 2. Obsessive Compulsive Drug Use Scale (OCDUS) 3. Positive And Negative Symptoms Scale (PANSS) based on information from the semi-structured interview (SCI-PANSS) 4. Calgary Depression Rating Scale (CDRS) 5. Extra-Pyramidal Symptom Rating Scale (ESRS) 6. Clinical Global Impression (CGI) 7. Yale Brown Obsessive Compulsive Scale (Y-BOCS) 8. Desires for Drugs Questionnaire (DDQ) 9. Drug Use Self Report (DUSR) 10. Recent Drug Use Urinalysis (RDUU)
Key secondary outcome measure(s)	1. Drop out from the study 2. Medication compliance and medication switch, symptoms and rehospitalisations during one year follow up, measured with the Life Chart Schedule (LCS)
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Total final enrolment	128
Key inclusion criteria	1. Patients should be able to understand the study description and give informed consent 2. Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) 3. Patients experience a first or second psychotic episode 4. Age is between 18 and 30 years 5. No current use of clozapine 6. Patients must be reliable. They must agree to co-operate with all tests and examinations required by the protocol
Key exclusion criteria	1. Pregnancy 2. Lactating women 3. Female subject without adequate contraception 4. Known hypersensitivity to any ingredient of olanzapine or risperidone 5. Concomitant use of any other antipsychotic drug than olanzapine or risiperidone 6. Patients are not allowed to have received depot anti-psychotics for a period of at least three months prior to the study 7. Use of other psychotropic medication other than oxazepam or biperiden 8. Narrow-angle glaucoma 9. Known neurological or endocrine disease
Date of first enrolment	01/07/2003
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Amsterdam
1105 BC
Netherlands

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2008	07/01/2021	Yes	No

Editorial Notes

07/01/2021: Publication reference and total final enrolment added.