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The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
escitalopram
Sponsored by
BeerYaakov Mental Health Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring negative symptoms, depression, ssri, schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Iulian Iancu

Outcomes

Primary Outcome Measures

negative symptoms
social function

Secondary Outcome Measures

positive symptoms
Clinical Global Impression (CGI)
depression

Full Information

First Posted
September 6, 2005
Last Updated
May 2, 2007
Sponsor
BeerYaakov Mental Health Center
Collaborators
Lundbeck Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00148447
Brief Title
The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia
Official Title
Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
BeerYaakov Mental Health Center
Collaborators
Lundbeck Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
negative symptoms, depression, ssri, schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
escitalopram
Primary Outcome Measure Information:
Title
negative symptoms
Title
social function
Secondary Outcome Measure Information:
Title
positive symptoms
Title
Clinical Global Impression (CGI)
Title
depression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iulian Iancu, M.D.
Organizational Affiliation
Beer Yaakov Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moshe Kotler, M.D.
Organizational Affiliation
Beer Yaakov Mental Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
Iulian Iancu
City
Beer Yaakov
ZIP/Postal Code
POB 1
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15876902
Citation
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.
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The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia

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