The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00148447

Enrollment

Registered

2005-09-08

Start date

2004-11-30

Completion date

2005-09-30

Last updated

2007-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

negative symptoms, depression, ssri, 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).

Interventions

DRUGescitalopram

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
negative symptoms	—
social function	—

Secondary

Measure	Time frame
positive symptoms	—
Clinical Global Impression (CGI)	—
depression	—

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026