Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Sheba Medical Center.
Recruitment status was: Recruiting
Information provided by:
Sheba Medical Center
First received: May 30, 2007
Last updated: March 24, 2009
Last verified: March 2009
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone
Primary Outcome Measures:
- cognitive functioning [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Discontinuation due to all causes, symptomatology and adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||October 2011 (Final data collection date for primary outcome measure)
Oral (tablets), 16-24 mg QD (once a day) for 12 weeks.
Other Name: Serdolect
Active Comparator: Risperidone
Oral (tablets), 4-8 mg QD (once a day) for 12 weeks.
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00480844
|Department of Psychiatry of the Sheba Medical Center
|Ramat Gan, Tel Hashomer, Israel, 52621 |
|Beer-Yaakov Mental Health Center
|Beer-Yaakov, Israel, 70350 |
|Kfar Shaul Mental Health Center
|Jerusalem, Israel, 91060 |
Sheba Medical Center
||Mark Weiser, Dr
||Shaba Medical Center, Tel-Aviv University Sackler School of Medicine
||Prof. Mark Weiser, Sheba Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 30, 2007
||March 24, 2009
||Israel: Israeli Health Ministry Pharmaceutical Administration
Keywords provided by Sheba Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 18, 2017
Schizophrenia Spectrum and Other Psychotic Disorders
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants