Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Sertindole (Drug); Risperidone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s): Mark Weiser, Dr, Principal Investigator, Affiliation: Shaba Medical Center, Tel-Aviv University Sackler School of Medicine
Overall contact: Mark Weiser, Dr, Phone: 03-5303773, Email: mweiser@netvision.net.il
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.
Clinical Details
Official title: Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: cognitive functioning
Secondary outcome: Discontinuation due to all causes, symptomatology and adverse events.
Detailed description:
Introduction:
In this proposal 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.
Study Drugs:
Risperidone is an "atypical" antipsychotic drug, being used widely all over the world. In
Israel, Risperidone has been the first line drug for schizophrenia at the past decade. This
drug was shown to be efficacious with bearable side effects. The side effects include:
tiredness, dizziness, muscle dystonia, increased appetite and weight, dry mouth,
constipation, tremor, orthostatic hypotension.
Sertindole is another "atypical" antipsychotic drug. The drug has been approved by the
Israeli Ministry of Health. Sertindole was initially marketed in Britain on 1996. It was
taken off the market, following several reports of cardiovascular deaths suspected to be
caused by the drug (i. e. prolongation of the QT-interval in the ECG, suspected to cause
ventricular arrhythmias). After renewing research, investigating more then 10000 patients
for several years, the drug was found to be as safe as other antipsychotics. On 2002, the
European union decided to put the Sertindole to the market.
Common Sertindole side effects are: dizziness, parasthesias, edema, orthostatic hypotension,
nasal congestion, dyspnea, dry mouth, decreased semen volume, increased weight, prolongation
of QT-interval in ECG.
Subjects and methods:
Overview: We propose to perform a multi-center, randomized, parallel-group, open-label study
administering Sertindole or Risperidone to patients with schizophrenia, N=60. The primary
outcome measure will be cognitive functioning. Secondary outcome measures will be
discontinuation due to all causes, symptomatology and adverse events.
Procedure and Instruments:
Subjects:
Sixty male and female subjects will be recruited from patients treated in the inpatient and
outpatient units in the Department of Psychiatry of the Sheba Medical Center, the
Beer-Yaakov Mental Health Center and the Kfar Shaul Mental Health Center. Before inclusion
into the study, patients will receive a careful medical workup, including complete medical
history, physical examination; routine blood chemistry and blood count, EKG and urinalysis.
Inclusion and exclusion criteria will be based on the SmPCs of both compounds.
Medication:
The doses of study medication used will be based on the doses currently recommended by the
manufacturers: Sertindole: 16-20 mg/day (in exceptional cases subjects will receive 24
mg/day, based on the clinical reasoning) or Risperidone 4-8 mg/day.
Duration:
Duration of randomized, open-label treatment will be 12 weeks. Following this phase, an
additional 12 week phase with Sertindole will be offered to subjects who were previously
randomized to the Risperidone arm.. As per IRB requirements, patients responding to
Sertindole will be eligible to receive Sertindole as compassionate care(in accordance wit
MOH requirements for compassionate care)
Assessment instruments:
- the following assessment scales will be administered before randomization, after 12
weeks of randomized treatment, and , if applicable, following 12 weeks of with
Sertindole Positive symptoms will be assessed by PANSS (Positive and Negative Syndrome
Scale)
- Negative symptoms will be assessed by SANS (Scale of the Assessment of Negative
Symptoms)
- Cognitive functioning will be assessed using MATRICS (Measurement And Treatment
Research to Improve Cognition in Schizophrenia).
- Movement disorders will be assessed by the Simpson Angus Scale and AIMS (Abnormal
Involuntary Movement Scale) scales
- Blood levels of glucose, triglycerides and cholesterol
- Weight, height, and vital signs will be measured and recorded
- ECG
Tests which are language-sensitive have been standardized and will be in assessed in Hebrew.
Assessment will be made by a rater who is blinded to the treatment.
Concomitant Medications:
Patients receiving mood-stabilizers, anti-depressants, sedatives and hypnotics will be
allowed to participate in the study only if they are on a stable dose of these medications
for 2 weeks before entering the trial. After randomization, changes in the doses of
concomitant medications will be recorded and analyzed at the end of the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Mark Weiser, Dr, Phone: 03-5303773, Email: mweiser@netvision.net.il
Beer-Yaakov Mental Health Center, Beer-Yaakov 70350, Israel; Not yet recruiting Yehuda Abramowitz, Dr, Principal Investigator
Kfar Shaul Mental Health Center, Jerusalem 91060, Israel; Not yet recruiting Alexander Teitelbaum, Dr, Principal Investigator
Department of Psychiatry of the Sheba Medical Center, Ramat Gan, Tel Hashomer 52621, Israel; Recruiting Mark Weiser, Dr, Phone: 03-5303773, Email: mweiser@netvision.net.il Mark Weiser, Dr, Principal Investigator
Additional Information
Starting date: October 2008
Last updated: March 24, 2009
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