Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sheba Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Sheba Medical Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00480844
First received: May 30, 2007
Last updated: March 24, 2009
Last verified: March 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Sertindole Drug: Risperidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Risperidone
U.S. FDA Resources
Further study details as provided by Sheba Medical Center:
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: | 60 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sertindole |
Drug: Sertindole
Oral (tablets), 16-24 mg QD (once a day) for 12 weeks.
Other Name: Serdolect
|
| Active Comparator: Risperidone |
Drug: Risperidone
Oral (tablets), 4-8 mg QD (once a day) for 12 weeks.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480844
Contacts
| Contact: Mark Weiser, Dr | 03-5303773 | mweiser@netvision.net.il |
Locations
| Israel | |
| Department of Psychiatry of the Sheba Medical Center | Recruiting |
| Ramat Gan, Tel Hashomer, Israel, 52621 | |
| Contact: Mark Weiser, Dr 03-5303773 mweiser@netvision.net.il | |
| Principal Investigator: Mark Weiser, Dr | |
| Beer-Yaakov Mental Health Center | Not yet recruiting |
| Beer-Yaakov, Israel, 70350 | |
| Principal Investigator: Yehuda Abramowitz, Dr | |
| Kfar Shaul Mental Health Center | Not yet recruiting |
| Jerusalem, Israel, 91060 | |
| Principal Investigator: Alexander Teitelbaum, Dr | |
Sponsors and Collaborators
Sheba Medical Center
Investigators
| Principal Investigator: | Mark Weiser, Dr | Shaba Medical Center, Tel-Aviv University Sackler School of Medicine |
More Information
No publications provided
| Responsible Party: | Prof. Mark Weiser, Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00480844 History of Changes |
| Other Study ID Numbers: | SHEBA-07-4639-JL-CTIL |
| Study First Received: | May 30, 2007 |
| Last Updated: | March 24, 2009 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
schizophrenia Sertindole Risperidone cognitive impairment |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Sertindole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on June 18, 2013