- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00148447
The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia
May 2, 2007 updated by: BeerYaakov Mental Health Center
Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia
The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study.
Study Overview
Detailed Description
The aim of this study is to evaluate the therapeutic effect of escitalopram (cipralex) in the treatment of negative symptoms in schizophrenic patients receiving either typical or the newer atypical antipsychotics (olanzapine and risperidone) in a double-blind placebo-controlled study.
As there is no drug treatment that is considered as first-line treatment in the treatment of negative symptoms, we thought that the comparison with placebo is plausible.
However, it is important to note that the patients will receive the commonly used treatment for their disorder (i.e.
antipsychotic medication).
Study Type
Interventional
Enrollment
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beer Yaakov, Israel, POB 1
- Iulian Iancu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic schizophrenia patients,
- Age <60,
- Medicated,
- Inpatients and outpatients,on stable doses of antipsychotic medications for at least one month before the study entry.
- Patients will be clinically stable and free of any additional axis I diagnosis or significant medical illnesses before enrollment into the study.
- A Positive and Negative Syndrome Scale (PANSS) score of 50 or above will be required for entry to the study.
Exclusion Criteria:
- Comorbidity with mania or major depression,
- Pregnancy,
- Lactation,
- Impaired renal or hepatic function,
- History of sensitivity to cipramil or to other drugs from the selective serotonin reuptake inhibitor (SSRI) group.
- Additional exclusion criteria will consist of mental retardation, organic conditions (brain tumors, drug abuse) and severe exacerbation of the psychiatric condition (i.e. suicide attempt, severe psychotic exacerbation) as defined by hospitalization in high-security units, clinical impression and CGI scores of "condition much worsened".
- Patients will be excluded during the study if they will remove their informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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negative symptoms
|
social function
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Secondary Outcome Measures
Outcome Measure |
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depression
|
positive symptoms
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Clinical Global Impression (CGI)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Iulian Iancu, M.D., Beer Yaakov Mental Health Center
- Study Chair: Moshe Kotler, M.D., Beer Yaakov Mental Health Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Study Completion
September 1, 2005
Study Registration Dates
First Submitted
September 6, 2005
First Submitted That Met QC Criteria
September 6, 2005
First Posted (Estimate)
September 8, 2005
Study Record Updates
Last Update Posted (Estimate)
May 3, 2007
Last Update Submitted That Met QC Criteria
May 2, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- Escitalopram-118CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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