Text Size

The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Israel
Information provided by:
BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:
NCT00148447
First received: September 6, 2005
Last updated: May 2, 2007
Last verified: February 2007
History of Changes
  Purpose

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
Schizophrenia
 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:

U.S. FDA Resources

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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
depression
ssri
schizophrenia

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

ClinicalTrials.gov processed this record on May 16, 2013