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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.
ClinicalTrials.gov 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

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.

Condition or disease Intervention/treatment
Schizophrenia Drug: Citalopram (Celexa) Drug: Placebo

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Citalopram Augmentation in Older Patients With Schizophrenia
Study Start Date : September 2001
Primary Completion Date : September 2006
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Participants will take placebo
Drug: Placebo
Placebo for 3 months
Active Comparator: 2
Participants will take citalopram (Celexa)
Drug: Citalopram (Celexa)
Citalopram for 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047450

United States, California
San Diego VA Medical Center
San Diego, California, United States, 92161
United States, Ohio
Veterans Administration Hospital of Cincinnati
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
Veterans Medical Research Foundation
National Institute of Mental Health (NIMH)
Principal Investigator: Sidney Zisook, MD University of California, San Diego

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidney Zisook, Research Scientist, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00047450     History of Changes
Obsolete Identifiers: NCT00046098
Other Study ID Numbers: R01MH063931 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2002    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Keywords provided by Sidney Zisook, Veterans Medical Research Foundation:
Psychotic Disorders

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents