Optimization of Treatment and Management of Schizophrenia in Europe - the optimise trial

Phase 1

Conditions: Schizophrenia ICD-10 code F20 or schizophreniform disorder ICD-10 code F23.1
MedDRA version: 12.1Level: LLTClassification code 10039626Term: Schizophrenia
MedDRA version: 12.1Level: LLTClassification code 10039647Term: Schizophreniform disorder

Registration Number: EUCTR2010-020185-19-ES

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

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
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test guideline recommendation that non-responders to an antipsychotic drug benefit from a switch to an antipsychotic with a different receptor binding profile.;Secondary Objective: To test applicability of amisulpride as the first step in a treatment algorithm.;Primary end point(s): The primary outcome is the number of participants in remission at the end of phase I (4 weeks open treatment with amisulpride), phase II (double-blind treatment with amisulpride or olanzapine, comparison between arms). Symptomatic remission will be defined according to the criteria of Andreasen et al. (2005): 8 specific symptoms (PANSS items P1, P2, P3, N1, N4, N6, G5 and G9) of schizophrenia as measured by the Positive and Negative Syndrome Scale (Kay et al. 1987) are at the most only mildly present (maximum rating of ?3?) so that they do not interfere with daily life functioning.

Secondary Outcome Measures