Optimising treatment of patient suffering from schizophrenia in Europe

Phase 1

Conditions: Schizophrenia ICD-10 code F20 or schizophreniform disorder ICD-10 code F23.1
MedDRA version: 18.0Level: HLTClassification code 10039620Term: Schizoaffective and schizophreniform disordersSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 18.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2010-020185-19-DK

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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 500
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