Schizophrenia Termination Of Pharmacotherapy: STOP-trial
- Conditions
- Schizophrenia, schizophreniform disorder, schizoaffective disorderMental and Behavioural DisordersSchizophrenia
- Registration Number
- ISRCTN06332944
- Lead Sponsor
- The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse, operationalised as follows:<br>The reappearance of psychotic symptoms:<br>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<br>2. As expressed by the necessity (and actual fact) of an admittance for psychiatric reasons
- Secondary Outcome Measures
Name Time Method