EUCTR2010-020185-19-CZ
Active, not recruiting
Not Applicable
Optimization of Treatment and Management of Schizophrenia in Europe - OPTiMiSE
ConditionsSchizophrenia ICD-10 code F20 or schizophreniform disorder ICD-10 code F23.1MedDRA version: 13.1Level: PTClassification code 10039647Term: Schizophreniform disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 13.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia ICD-10 code F20 or schizophreniform disorder ICD-10 code F23.1
- Sponsor
- niversity Medical Center Utrecht
- Enrollment
- 350
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Diagnosis of schozophrenia, schizophreniform or schizoaffective disorder as defined by DSM\-IV on the basis of the Mini International Neuropsychiatric Interview Plus (M.I.N.I. Plus;Sheehan et al. 1998\).
- •\-Age 18\-40 years
- •\-Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\-A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.
- •\-Prior use of antipsychotic medication longer than an episode of two weeks in the previous year and/or 6 weeks lifetime.
- •\-Intolerance to one of the drugs in this study.
- •\-Patients who are coercively treated at a psychiatric ward (based on a judicial ruling)
- •\-Patients who are represented by a legal ward or under legal custody
- •\-The presence of one or more of the contraindications against any of the study drugs as mentioned in the IB texts
- •\-Pregnancy or lactation
Outcomes
Primary Outcomes
Not specified
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