The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

May 2, 2007

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

negative symptoms
social function

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00148447 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

positive symptoms
Clinical Global Impression (CGI)
depression

Original Secondary Outcome Measures ^ICMJE

positive symptoms
cgi
depression

Descriptive Information

Brief Title ^ICMJE

The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

Official Title ^ICMJE

Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: escitalopram

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00148447

Responsible Party

Study ID Numbers ^ICMJE

Escitalopram-118CTIL

Study Sponsor ^ICMJE

BeerYaakov Mental Health Center

Collaborators ^ICMJE

Lundbeck Israel

Investigators ^ICMJE

Principal Investigator:	Iulian Iancu, M.D.	Beer Yaakov Mental Health Center
Study Chair:	Moshe Kotler, M.D.	Beer Yaakov Mental Health Center

Information Provided By

BeerYaakov Mental Health Center

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP