Prediction of therapy response and treatment outcomes in early course of schizophrenia.Subproject D1_AP2 of the research network ESPRIT (Enhancing Schizophrenia Prevention and Recovery through Innovative Treatments)

Recruiting

Conditions: DSM IV-TR:295.10-30, 295.90: Schizophrenia High Risc State of transmission to psychosis

Registration Number: DRKS00010936

Lead Sponsor: Klinik und Poliklinik für Psychiatrie und Psychotherapie,LVR-Klinikum Düsseldorf / Kliniken der Heinrich Heine Universität Düsseldorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

The study sample includes all patients (diagnosis: schizophrenia resp. people at high risk of developing psychosis) finalizing RCTs and clinical trials consenting to the follow-up. Key inclusion criteria: same as RCTs or clinical trials, no additional inclusion criteria for long-term follow-up

Exclusion Criteria

Key exclusion criteria: same as RCTs or clinical trials, no additional exclusion criteria for long-term follow-up.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prediction analyses on the one hand will focus on the standardized main outcome variables of ESPRIT-studies: discontinuation, transition from at-risk to manifest stages of psychosis as criteria. On the other hand criteria used in previous (own and other) prediction studies will be used as dependent variable (criteria), e.g. treatment responses regarding symptomatology (symptomatic remission”, relapse”/”clinical deterioration”) meassured by the PANSS-Score or CGI-Change-Score or measures of social functioning (e.g. SOFAS). <br>The analyzed data are measured in all 4 RCTs at baseline, after four months, six months (end of treatment) and after 12 months (Follow-Up).

Secondary Outcome Measures

Name	Time	Method
Predictors: <br>- Duration of untreated psychosis<br>- age at illness onset<br>- premorbid functioning (SOFAS)<br>- therapy adherence (SES, DAI, PATHEV)<br>- symptoms (PANSS)<br>- cognitive functioning (PFA; MASC; Digital symbol test, VLMT, TMT A and B, digitspan)<br>- gender<br>- drug abuse<br>- type of medication<br>- Side effects of medication (UKU)<br>- caseness (MINI 6.0)