EFFICACY OF SERTINDOLE AS COMPARED TO OLANZAPINE OR RISPERIDONE ON PREATTENTIONAL AND ATTENTION-DEPENDENT FUNCTIONS IN PATIENTS WITH CHRONIC SCHIZOPHRENIA. A COGNITIVE AND FMRI STUDY. -

• Conditions: schizophrenia

• Registration Number: EUCTR2008-001128-30-HU
• Lead Sponsor: SE Dept. of Psychiatry and Psychotherapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria
- Diagnosis: DSM-IV schizophrenia (any subtype).
- Age: 18-65 years.
- Sex: Male, or non pregnant female subjects
- General Health: Satisfactory medical assessment with no clinically significant and relevant abnormalities.
- Duration of illness: >5 years
- Concomitant standing or prn medications (except other antipsychotics and those contraindicated in the respective package inserts) are permitted during all treatment phases, if they were present at a stable dose for at least 6 weeks prior to the start of initial treatment with study medication.
- Overall symptom severity: patients must evidence a total score of 60 or higher on the PANSS scale
- Clinical Symptoms: A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility).
- Cognitive status (minimum performance level): subject must be able to validly complete the baseline RBANS assessment (validity of performance to be assessed by Chief Neuropsychologist or NP tester).
- Clinical judgment by the investigator that treatments with Sertindole, Olanzapine or Risperidone are warranted due to suboptimal clinical outcome despite previous treatments
- Patient is judged capable of understanding all relevant risks and potential benefits of the study and provides 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

Exclusion criteria
- Past or current intolerance of Sertindole, Olanzapine or Risperidone side effects that are judged by the investigator to be unsafe, dose-limiting, or likely to result in study discontinuation.
- Any contraindication for Sertindole, Olanzapine or Risperidone therapy as indicated in the drug description.
- Presence of any unstable or untreated medical disorder.
- Any history of seizures or seizure disorder other than febrile seizures of childhood;
- History of positive hepatitis B surface antigen.
- Any abnormal laboratory test that is judged to be clinically significant by the investigator.
- A history of significant head injury/trauma, as defined by:
- loss of consciousness for more than 1 hour
- recurring seizures resulting from the head injury
- clear cognitive sequelae of the injury
- cognitive rehabilitation following the injury

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary goal is to compare neurocognitive effects of Sertindole on preattentive and attention-dependent cognitive measures with those of Olanzapine and Risperidone in patients with chronic schizophrenia, as assessed by the Pre-Pulse Inhibition (PPI) and the Continuous Performance Task (CPT) Paradigms. ;Secondary Objective: The secondary objective will be to delineate cortical networks that are associated with improvement in functioning in the preattentional and attention-dependent cognitive processes during PPI and CPT tasks, as assessed by functional magnetic resonance imaging after treatment Sertindole, Olanzapine or Risperidone.;Primary end point(s): Primary<br>Magnitude of Pre-Pulse Inhibition in the PPT task, and task performance in terms of correct and incorrect target detections (hits and false alarms) as well as signal-to-noise discrimination in the CPT task.<br>