The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: escitalopram (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: BeerYaakov Mental Health Center

Official(s) and/or principal investigator(s):
Iulian Iancu, M.D., Principal Investigator, Affiliation: Beer Yaakov Mental Health Center
Moshe Kotler, M.D., Study Chair, Affiliation: Beer Yaakov Mental Health Center

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.

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

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

Primary outcome:

negative symptoms

social function

Secondary outcome:

positive symptoms

Clinical Global Impression (CGI)

depression

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).

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Iulian Iancu, Beer Yaakov POB 1, Israel

Related 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.

Starting date: November 2004
Ending date: September 2005
Last updated: May 2, 2007