Schizophrenia Termination Of Pharmacotherapy: STOP-trial

ISRCTN	ISRCTN06332944
DOI	https://doi.org/10.1186/ISRCTN06332944
Protocol serial number	ZonMw: 2100.0057; NTR179
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Funders	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands), Eli Lilly Nederland BV (The Netherlands)

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

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
Email	g.boonstra@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

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