Schizophrenia | Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone
Schizophrenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SertindoleOral (tablets), 16-24 mg QD (once a day) for 12 weeks.
Drug:RisperidoneOral (tablets), 4-8 mg QD (once a day) for 12 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2008
Phase: Phase 4
Primary Outcome: cognitive functioning
Secondary Outcome: Discontinuation due to all causes, symptomatology and adverse events.
Study sponsors, principal investigator, and references
Principal Investigator: Mark Weiser, Dr
Lead Sponsor: Sheba Medical Center