EUCTR2010-020185-19-BE
Active, not recruiting
Phase 1
Optimization of Treatment and Management of Schizophrenia in Europe - the optimise trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Medical Center Utrecht
- Enrollment
- 446
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of schizophrenia, 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 350
- •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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