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The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00148447
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 3, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: escitalopram Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia
Study Start Date : November 2004
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. negative symptoms
  2. social function

Secondary Outcome Measures :
  1. positive symptoms
  2. Clinical Global Impression (CGI)
  3. depression

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00148447


Locations
Israel
Iulian Iancu
Beer Yaakov, Israel, POB 1
Sponsors and Collaborators
BeerYaakov Mental Health Center
Lundbeck Israel
Investigators
Principal Investigator: Iulian Iancu, M.D. Beer Yaakov Mental Health Center
Study Chair: Moshe Kotler, M.D. Beer Yaakov Mental Health Center
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00148447     History of Changes
Other Study ID Numbers: Escitalopram-118CTIL
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: February 2007

Keywords provided by BeerYaakov Mental Health Center:
negative symptoms
depression
ssri
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents