ISRCTN06332944
Completed
Not Applicable
Prevention of iatrogenic neurological impairment in schizophrenic disorders: the Schizophrenia Termination of Pharmacotherapy (STOP) trial
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)0 sites20 target enrollmentDecember 20, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia, schizophreniform disorder, schizoaffective disorder
- Sponsor
- The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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