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Antidepressant Treatment in Older Adults With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Citalopram (Celexa)
Placebo
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Psychotic Disorders

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Schizophrenia or schizoaffective disorder HAM-D score of 8 or above Antipsychotic medication treatment

Sites / Locations

  • San Diego VA Medical Center
  • Veterans Administration Hospital of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Participants will take placebo

Participants will take citalopram (Celexa)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 4, 2002
Last Updated
August 6, 2013
Sponsor
Veterans Medical Research Foundation
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00047450
Brief Title
Antidepressant Treatment in Older Adults With Schizophrenia
Official Title
Citalopram Augmentation in Older Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Older people with schizophrenia suffer from greater physical comorbidity, cognitive impairment, and medication side effects compared to their younger counterparts. Unfortunately, little research is available to guide the treatment of subsyndromal depressive symptoms in older adults. This study will compare the antidepressant citalopram to placebo to determine the most effective treatment for reducing depressive symptoms in older patients with schizophrenia After patients have been on stable treatment with antipsychotic medication for at least 4 weeks, they are randomly assigned to receive antipsychotic medication plus either citalopram or placebo for 3 months. Depressive symptoms and side effects are assessed weekly for the first month, biweekly for the second month, and again at the end of the third month. Cognition, motor and daily functioning, quality of life, and medication adherence are assessed throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Participants will take placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will take citalopram (Celexa)
Intervention Type
Drug
Intervention Name(s)
Citalopram (Celexa)
Intervention Description
Citalopram for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Schizophrenia or schizoaffective disorder HAM-D score of 8 or above Antipsychotic medication treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidney Zisook, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego VA Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Veterans Administration Hospital of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20361918
Citation
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.
Results Reference
derived
PubMed Identifier
19192468
Citation
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.
Results Reference
derived
Links:
URL
http://geropsych.ucsd.edu
Description
UCSD Geropsychiatry Advanced Clinical Intervention And Services Research Center

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Antidepressant Treatment in Older Adults With Schizophrenia

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