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Antidepressant Treatment in Older Adults With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sidney Zisook, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00047450
First received: October 4, 2002
Last updated: August 6, 2013
Last verified: August 2013
October 4, 2002
August 6, 2013
September 2001
September 2006   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00047450 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antidepressant Treatment in Older Adults With Schizophrenia
Citalopram Augmentation in Older Patients With Schizophrenia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Citalopram (Celexa)
    Citalopram for 3 months
  • Drug: Placebo
    Placebo for 3 months
  • Placebo Comparator: 1
    Participants will take placebo
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Participants will take citalopram (Celexa)
    Intervention: Drug: Citalopram (Celexa)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
September 2007
September 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Schizophrenia or schizoaffective disorder
  • HAM-D score of 8 or above
  • Antipsychotic medication treatment
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00047450
R01MH063931( U.S. NIH Grant/Contract )
R01MH063931 ( U.S. NIH Grant/Contract )
DATR A4-GPX
Yes
Not Provided
Not Provided
Sidney Zisook, Veterans Medical Research Foundation
Veterans Medical Research Foundation
National Institute of Mental Health (NIMH)
Principal Investigator: Sidney Zisook, MD University of California, San Diego
Veterans Medical Research Foundation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP