The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00148447
• Lead Sponsor: BeerYaakov Mental Health Center

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 Timeline

• Study Start: 2004-11
• Study Completion: 2005-09
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2007-02
• Last Update Submitted: 2007-05-02
• Last Update Posted: 2007-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
negative symptoms
social function

Secondary Outcome Measures

Name	Time	Method
positive symptoms
Clinical Global Impression (CGI)
depression

Trial Locations

Locations (1)

Iulian Iancu; 🇮🇱 Beer Yaakov, Israel