Management of Schizophrenia

Phase 1

Conditions: First episode schizophrenic and schizoaffective patients
MedDRA version: 15.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 15.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2010-020185-19-IT

Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA' DEGLI STUDI DI NAPOLI

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.
Age 18 40 years
Written informed consent.
Female patients of childbearing potential need to utilize a proper method of contraception as the pill, vaginal ring, hormonal patch, intrauterine device, cervical cape, condom, contraceptive injection, diaphragm, abstinence.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
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 psychosis 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
Patients who are represented by a legal guardian 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, as determined through a pregnancy test, or lactation