Schizophrenia Termination Of Pharmacotherapy: STOP-trial
ISRCTN | ISRCTN06332944 |
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DOI | https://doi.org/10.1186/ISRCTN06332944 |
Secondary identifying numbers | ZonMw: 2100.0057; NTR179 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/11/2008
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr G Boonstra
Scientific
Scientific
University Medical Center Utrecht
Division Brain, Department Adult Psychiatry
Housepost A.01.126, Room A.01.5.04
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
Phone | +31 (0)30 250 7121 |
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g.boonstra@umcutrecht.nl |
Study information
Study design | Multicentre, randomised, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Prevention of iatrogenic neurological impairment in schizophrenic disorders: the Schizophrenia Termination of Pharmacotherapy (STOP) trial |
Study acronym | STOP trial |
Study objectives | H0: continuation or cessation of antipsychotic therapy in psychosis free stable first episode patients with a schizophrenic disorder makes no difference with regard to relapse rates or side-effects. |
Ethics approval(s) | Received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Schizophrenia, schizophreniform disorder, schizoaffective disorder |
Intervention | 1. The patient continues with taking the antipsychotic medication according to his/her medication schedule at the day of inclusion and continues this schedule for at least 6 months 2. The patient tapers the antipsychotic medication in minimally 6 and maximally 12 weeks to zero (if possible) |
Intervention type | Other |
Primary outcome measure | Relapse, operationalised as follows: The reappearance of psychotic symptoms: 1. As measured by an increase in the total score on the PANSS with at least 20%, and the score of 1 of the following PANSS items being more than 3: Delusions (P1), Conceptual disorganisation (P2), Hallucinations (P3) and Suspicion (P6), or 2. As expressed by the necessity (and actual fact) of an admittance for psychiatric reasons |
Secondary outcome measures | 1. Changes over 2 years in score on the Positive And Negative Syndrome Scale (PANSS) or subscales 2. Changes over 2 years in score on the Calgary Depression Rating Scale (CDRS) 3. Changes over 2 years in score on the Global Assessment of Functioning (GAF) 4. Changes over 2 years in score on the Clinical Global Impression scale (CGI) 5. Changes over 2 years in score on the Unified Parkinson Disease Rating Scale (UPDRS) 6. Changes over 2 years in score on the Abnormal Involuntary Movements Scale (AIMS) 7. Changes over 2 years in score on the Barnes Akathisia Rating Scale (BARS) 8. Changes over 2 years in score on the substance abuse module of the Structured Clinical Interview for DSM-IV (SCID-substance module) 9. Changes over 2 years in brain morphology as measured by structural magnetic resonance imaging (MRI) after 0, 6, 12 and 24 months 10. Changes over 2 years in score in the weight of the patient 11. Changes over 2 years in score on the compliance of the patient as measured by the Medication Adherence Rating Scale (MARS) 12. Quality of life measured at the end of the study (WHO-QOL-brief) 13. Number of life-events as measured at the end of the study (Life Events Questionnaire) 14. Quality of life and health measured by the RAND-36 15. Brain morphologic changes in time taking into account antipsychotic medication use |
Overall study start date | 24/07/2002 |
Completion date | 01/07/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 20 |
Key inclusion criteria | 1. Written informed consent obtained after oral and written explanation to the patient and its doctor 2. Aged 16 to 55 years 3. Treated for at least a year, with antipsychotics, for a first episode of schizophrenia, schizoaffective disorder of schizophreniform disorder before inclusion 4. Diagnosis code 195.10, 295.20, 295.30, 295.60, 295.70 of 295.40 according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria as assessed at inclusion with the SCID (Structured Clinical Interview for DSM-IV) 5. The patient used antipsychotics for at least 335 days during the last year 6. All of the last year the patient was in a state of clinical remission, meant is that no clear symptoms of psychosis were observed, operationalised by the lack of a score of more then 3 on the following PANSS-items (Positive And Negative Syndrome Scale): Delusions (P1), Conceptual disorganisation (P2), Hallucinations (P3) and Suspicion (P6). Possibly there were still mild rest symptoms of which the patient experienced no hinder in daily functioning. 7. No serious physical disorder 8. No psychosis during inclusion, as operationalised under item 6 9. The patient has to be able to understand and undergo the trial procedures |
Key exclusion criteria | 1. Judgment of the treating psychiatrist of the patient 2. The occurrence of a serious physical disease 3. Withdrawal of the informed consent of the patient 4. Death of the patient |
Date of first enrolment | 24/07/2002 |
Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
Den Haag
2593 CE
Netherlands
Phone | +31 (0)30 602 5800 |
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info@zonmw.nl | |
Website | http://www.zonmw.nl/ |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Eli Lilly Nederland BV (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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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 |