The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148447
• Other study ID #: Escitalopram-118CTIL
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: May 2, 2007
• Start date: November 2004
• Est. completion date: September 2005

Study information

• Verified date: February 2007
• Source: BeerYaakov Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• escitalopram

Locations

Country	Name	City	State
Israel	Iulian Iancu	Beer Yaakov

Sponsors (2)

Lead Sponsor	Collaborator
BeerYaakov Mental Health Center	Lundbeck Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	negative symptoms
Primary	social function
Secondary	positive symptoms
Secondary	Clinical Global Impression (CGI)
Secondary	depression