Antidepressant Treatment in Older Adults With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047450
Recruitment Status : Completed
First Posted : October 7, 2002
Last Update Posted : August 9, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sidney Zisook, Veterans Medical Research Foundation

October 4, 2002
October 7, 2002
August 9, 2013
September 2001
September 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00047450 on Archive Site
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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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • 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 Identifier (NCT Number) in Medline.
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, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH063931( U.S. NIH Grant/Contract )
R01MH063931 ( U.S. NIH Grant/Contract )
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