The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

This study has been completed.
Lundbeck Israel
Information provided by:
BeerYaakov Mental Health Center Identifier:
First received: September 6, 2005
Last updated: May 2, 2007
Last verified: February 2007
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 Intervention Phase
Drug: escitalopram
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia

Resource links provided by NLM:

Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:
  • negative symptoms
  • social function

Secondary Outcome Measures:
  • positive symptoms
  • Clinical Global Impression (CGI)
  • depression

Estimated Enrollment: 40
Study Start Date: November 2004
Estimated Study Completion Date: September 2005
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).

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00148447

Iulian Iancu
Beer Yaakov, Israel, POB 1
Sponsors and Collaborators
BeerYaakov Mental Health Center
Lundbeck Israel
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: Identifier: NCT00148447     History of Changes
Other Study ID Numbers: Escitalopram-118CTIL 
Study First Received: September 6, 2005
Last Updated: May 2, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by BeerYaakov Mental Health Center:
negative symptoms

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on February 09, 2016