NCT00148447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

May 3, 2007

Status Verified

February 1, 2007

First QC Date

September 6, 2005

Last Update Submit

May 2, 2007

Conditions

Schizophrenia

Keywords

negative symptomsdepressionssrischizophrenia

Outcome Measures

Primary Outcomes (2)

  • negative symptoms

  • social function

Secondary Outcomes (3)

  • positive symptoms

  • Clinical Global Impression (CGI)

  • depression

Interventions

escitalopramDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iulian Iancu

Beer Yaakov, POB 1, Israel

Location

Related Publications (1)

  • 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.

    PMID: 15876902BACKGROUND

MeSH Terms

Conditions

SchizophreniaDepression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Iulian Iancu, M.D.

    Beer Yaakov Mental Health Center

    PRINCIPAL INVESTIGATOR

  • Moshe Kotler, M.D.

    Beer Yaakov Mental Health Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

November 1, 2004

Study Completion

September 1, 2005

Last Updated

May 3, 2007

Record last verified: 2007-02

Locations

IL(1)