Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this study we intend to compare the effect of Sertindole to that of Risperidone on cognitive impairment in schizophrenia.

Hypothesis: Sertindole will be as effective as Risperidone for treating cognitive impairment in schizophrenia and with fewer side effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Risperidone; Sertindole

Criteria

Inclusion Criteria:

• Patients suffering from Schizophrenia (DSM IV).

• Failure of at least one previous antipsychotic for intolerance.

• Psychotic symptoms that are not secondary to a general medical condition or substance abuse.

• Ages between 18-65 years old.

• Patients receiving other psychotropic medications (anti-depressants, mood stabilizers, sedatives, hypnotics) must be on a stable dose for at least 2 weeks before entering the trial.

• Able to understand and sign an informed consent form.

Exclusion Criteria:

• Patients suffering from psychotic disorders caused by a general medical condition.

• Patients having high suicidal risk, as measured by score of 2 or more in CDSS - Calgary Depression Scale for Schizophrenia.

• Patients suffering from an unstable clinically significant medical condition (endocrine, nutritional, hepatic, urinary).

• Significant cardiovascular illness, and/or QT prolongation at screening (more then 450 msec for male or 470 msec for female).

• Patients suffering from a malignancy or neuro-degenerative illness (e.g. Parkinsons' Disease)

• Patients suffering from organic brain disorders, including epilepsy and mental retardation.

• Patients suffering from a clinically significant mood disorder.

• Pregnancy.

• History of drug or alcohol dependence within the last year.

• Previous documented non-response to Risperidone.

• Patients using medicinal products that are contraindicated with sertindole and/or Risperidone.