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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00047450 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Citalopram Augmentation in Older Patients With Schizophrenia |
| 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 |
|---|---|
|
1: Placebo Comparator
Participants will take placebo
|
Drug: Placebo
Placebo for 3 months
|
|
2: Active Comparator
Participants will take citalopram (Celexa)
|
Drug: Citalopram (Celexa)
Citalopram for 3 months
|
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 |
Inclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Sidney Zisook, MD | University of California, San Diego |
More Information
| Responsible Party: | UCSD ( Sidney Zisook, MD ) |
| Study ID Numbers: | R01 MH63931, DATR A4-GPX |
| Study First Received: | October 4, 2002 |
| Last Updated: | March 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00047450 History of Changes |
| Health Authority: | United States: Federal Government |
|
Psychotic Disorders |
|
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Schizophrenia Mental Disorders Therapeutic Uses |
Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents Schizophrenia and Disorders with Psychotic Features Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
