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Antidepressant Treatment in Older Adults With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00047450
First received: October 4, 2002
Last updated: March 4, 2008
Last verified: March 2008
History of Changes
  Purpose

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 Intervention
Schizophrenia
 Drug: Citalopram (Celexa)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Citalopram Augmentation in Older Patients With Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Enrollment: 212
Study Start Date: September 2001
Study Completion Date: September 2007
Estimated Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenia or schizoaffective disorder
  • HAM-D score of 8 or above
  • Antipsychotic medication treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047450

Locations
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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Sidney Zisook, MD University of California, San Diego
  More Information

Additional Information:
UCSD Geropsychiatry Advanced Clinical Intervention And Services Research Center  This link exits the ClinicalTrials.gov site

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sidney Zisook, MD, UCSD
ClinicalTrials.gov Identifier: NCT00047450     History of Changes
Obsolete Identifiers: NCT00046098
Other Study ID Numbers: R01 MH63931, DATR A4-GPX
Study First Received: October 4, 2002
Last Updated: March 4, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Psychotic Disorders

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on June 17, 2013