The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia - Full Text View

Sponsor:	BeerYaakov Mental Health Center
Collaborator:	Lundbeck Israel
Information provided by:	BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:	NCT00148447

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Depression Mental Health Schizophrenia

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

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:

Friedman JI, Ocampo R, Elbaz Z, Parrella M, White L, Bowler S, Davis KL, Harvey PD. The effect of citalopram adjunctive treatment added to atypical antipsychotic medications for cognitive performance in patients with schizophrenia. J Clin Psychopharmacol. 2005 Jun;25(3):237-42.

Study ID Numbers:	Escitalopram-118CTIL
Study First Received:	September 6, 2005
Last Updated:	May 2, 2007
ClinicalTrials.gov Identifier:	NCT00148447 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by BeerYaakov Mental Health Center:

negative symptoms
depression
ssri
schizophrenia

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Schizophrenia
Mental Disorders
Therapeutic Uses

Dexetimide
Antidepressive Agents, Second-Generation
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009