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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480844
Recruitment Status : Unknown
Verified March 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : May 31, 2007
Last Update Posted : March 25, 2009
Information provided by:
Sheba Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Sertindole Drug: Risperidone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone
Study Start Date : October 2008
Estimated Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
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:
  • Rispond
  • Risperdal
  • Risperidex

Primary Outcome Measures :
  1. cognitive functioning [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Discontinuation due to all causes, symptomatology and adverse events. [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480844

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Contact: Mark Weiser, Dr 03-5303773

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Department of Psychiatry of the Sheba Medical Center Recruiting
Ramat Gan, Tel Hashomer, Israel, 52621
Contact: Mark Weiser, Dr    03-5303773   
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
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Principal Investigator: Mark Weiser, Dr Shaba Medical Center, Tel-Aviv University Sackler School of Medicine
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Responsible Party: Prof. Mark Weiser, Sheba Medical Center Identifier: NCT00480844    
Other Study ID Numbers: SHEBA-07-4639-JL-CTIL
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by Sheba Medical Center:
cognitive impairment
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents