Skip to main content
OpenTrials
Completed

NCT Number: NCT00148447

The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Iulian Iancu

Beer Yaakov, POB 1, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

Primary outcomes

  1. negative symptoms

  2. social function

Secondary outcomes

  1. positive symptoms

  2. Clinical Global Impression (CGI)

  3. depression

Sponsors and collaborators

Lead sponsor

BeerYaakov Mental Health Center

Other Gov

Collaborators

  • Lundbeck Israel

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
May 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.