Effectiveness of newer antipsychotic drugs compared to conventional antipsychotic drugs in patients with schizophrenia

Conditions: Schizophrenia
MedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2009-010966-47-DE

Lead Sponsor: niversität Bremen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Key inclusion criteria:
Patients with schizophrenia, age 18-65, necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects.

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 630
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key exclusion criteria:
Acute suicidal tendency, Einwilligungsvorbehalt (BGB)” or Unterbringung (PsychKG), organic psychosis, history of malignant neuroleptic syndrome, QTc interval = 0.5s / history of congenital QTc prolongation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Contentment with treatment in 1) patients and 2) psychiatrists;<br>Patient: SF-36 (interviewer version with a time frame of one week); Psychiatrist: CGI.<br>;Secondary Objective: Subscores of SF-36, SWN-K, PSP, PANSS, matrics (selected centres).<br>Assessment of safety:<br>Adverse events, drop-out rates, SAS / AIMS / BARS and sexual dysfunction changes. Metabolic side effects: body mass index (BMI), waist circumference, HbA1c, fast blood glucose levels, lipid profile.<br><br><br>;Primary end point(s): Primary efficacy endpoint:<br>Contentment with treatment in 1) patients and 2) psychiatrists;<br>Patient: SF-36 (interviewer version with a time frame of one week); Psychiatrist: CGI.<br><br>;Timepoint(s) of evaluation of this end point: Baseline and 2, 4, 6, 12, 24 weeks after patient inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Subscores of SF-36 (AUC, logtime)<br>- SWN-K<br>- PSP (family member rating, rating by oneself, family member questionnaire)<br>- PANSS<br>;Timepoint(s) of evaluation of this end point: Baseline and 6, 24 weeks after patient inclusion