The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-09-30

Brief Summary

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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

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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).

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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escitalopram

Intervention Type DRUG

Eligibility Criteria

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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.
* Patients will be excluded during the study if they will remove their informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Iulian Iancu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beer Yaakov Mental Health Center

Moshe Kotler, M.D.

Role: STUDY_CHAIR

Beer Yaakov Mental Health Center

Locations

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Iulian Iancu

Beer Yaakov, , Israel

Site Status

Countries

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Israel

References

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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. doi: 10.1097/01.jcp.0000161499.58266.51.

Reference Type BACKGROUND

PMID: 15876902 (View on PubMed)

Other Identifiers

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Escitalopram-118CTIL

Identifier Type: -

Identifier Source: org_study_id