NCT00047450

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of citalopram (Celexa) for the treatment of depressive symptoms in middle-aged and elderly patients with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2002

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

5 years

First QC Date

October 4, 2002

Last Update Submit

August 6, 2013

Conditions

Schizophrenia

Keywords

Psychotic Disorders

Study Arms (2)

1

PLACEBO COMPARATOR

Participants will take placebo

Drug: Placebo

2

ACTIVE COMPARATOR

Participants will take citalopram (Celexa)

Drug: Citalopram (Celexa)

Interventions

Citalopram (Celexa)DRUG

Citalopram for 3 months

2
PlaceboDRUG

Placebo for 3 months

1

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia or schizoaffective disorder
  • HAM-D score of 8 or above
  • Antipsychotic medication treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Diego VA Medical Center

San Diego, California, 92161, United States

Location

Veterans Administration Hospital of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Related Publications (2)

  • Zisook S, Kasckow JW, Lanouette NM, Golshan S, Fellows I, Vahia I, Mohamed S, Rao S. Augmentation with citalopram for suicidal ideation in middle-aged and older outpatients with schizophrenia and schizoaffective disorder who have subthreshold depressive symptoms: a randomized controlled trial. J Clin Psychiatry. 2010 Jul;71(7):915-22. doi: 10.4088/JCP.09m05699gre. Epub 2010 Mar 9.

    PMID: 20361918DERIVED

  • Zisook S, Kasckow JW, Golshan S, Fellows I, Solorzano E, Lehman D, Mohamed S, Jeste DV. Citalopram augmentation for subsyndromal symptoms of depression in middle-aged and older outpatients with schizophrenia and schizoaffective disorder: a randomized controlled trial. J Clin Psychiatry. 2009 Apr;70(4):562-71. doi: 10.4088/jcp.08m04261. Epub 2008 Dec 16.

    PMID: 19192468DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sidney Zisook, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

October 4, 2002

First Posted

October 7, 2002

Study Start

September 1, 2001

Primary Completion

September 1, 2006

Study Completion

September 1, 2007

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

US(2)