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 |
| Secondary identifying numbers | NTR28 |
- 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
Scientific
Academic Medical Centre
University of Amsterdam
Adolescent Clinic
Department of Psychiatry
Tafelbergweg 25
Amsterdam
1105 BC
Netherlands
| Phone | +31 (0)20 566 2142 |
|---|---|
| L.J.vanNimwegen@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, parallel group, double-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Olanzapine and risperidone |
| Primary outcome measure | 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) |
| Secondary outcome measures | 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) |
| Overall study start date | 01/07/2003 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
1105 BC
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Psychiatry
Tafelbergweg 25
Amsterdam
1105 BC
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Industry
Eli Lilly (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
