Schizophrenic disorders: Schizophrenia Schizophreniform disorder Schizoaffective disorder
Conditions
Interventions
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).
Sponsors
Divisie Hersenen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained after oral and written explanation to the patient and its doctor; 2. Age 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 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, operationalized 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 operationalized under item 6; 9. The patient has to be able to understand and undergo the trial procedures.
Exclusion criteria
Exclusion criteria: 1. Judgement 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse, operationalized 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
| Measure | Time frame |
|---|---|
| 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 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. | — |
Contacts
Public ContactG. Boonstra
University Medical Center Utrecht (UMCU), Division Brain, Department Adult Psychiatry, Housepost A.01.126, Room A.01.5.04, Heidelberglaan 100
Outcome results
None listed