EUCTR2010-020185-19-GB
Active, not recruiting
Phase 1
Optimization of Treatment and Management of Schizophrenia in Europe - OPTiMiSE
niversity Medical Centre Utrecht0 sites446 target enrollmentDecember 6, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Schizophrenia ICD-10 code F20 or schizophreniform disorder ICD-10 code F23.1
- Sponsor
- niversity Medical Centre Utrecht
- Enrollment
- 446
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •i) 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\), a short diagnostic structured interview.
- •ii) Age 18\-40 years
- •iii) Written informed consent
- •iv) Mental capacity to understand and consent to the study (as determined using attached mental capacity assessment form).
- •For all participants at UK site:
- •iii) Adequate command of English to understand the study and complete the assessments
- •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
Exclusion Criteria
- •i) A time interval between the onset of positive symptoms (hallucinations and/or delusions) and study entry exceeding two years.
- •ii) Prior use of antipsychotic medication for longer than an episode of two weeks in the previous year and/or 6 weeks during lifetime.
- •iii) Intolerance to one of the drugs in this study.
- •iv) The presence of one or more of the contraindications against any of the study drugs
- •vi) Pregnancy, as determined through a pregnancy test, or lactation
- •vii) Lack of mental capacity to understand and consent to the study (as determined using attached mental capacity assessment form).
- •For participation in MRI scans only (if they meet this exclusion criteria, they can still participate in the rest of the study)
- •i) any contraindication to imaging e.g. implanted metallic objects or electronic devices
Outcomes
Primary Outcomes
Not specified
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