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Sponsored by: |
Sheba Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00650897 |
Patients with diabetes and major depression treated with Escitalopram might experience significant improvement in depression and anxiety scores; functional ability; diabetes-related self-care; and pain symptoms
Condition | Intervention | Phase |
---|---|---|
Major Depression Diabetes Mellitus |
Drug: Escitalopram |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Escitalopram Treatment of Major Depression in Diabetes Mellitus: An Open Label |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Patients with Diabetes Mellitus and Major Depression
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Drug: Escitalopram
10-20 mg once daily
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Major depression is common in patients diabetes (point prevalence about 15-20%). It has been shown that patients with diabetic and major depression experience more severe diabetes symptoms, greater disability, more frequent medical complications, greater healthcare utilization costs, poorer glycemic control, and greater difficulties with diabetes self-care activities, compared with patients with diabetes without depression. Few specific features of Escitalopram, a selective serotonin reuptake inhibitor (SSRI), make it a promising medication for use in diabetes. These include a benign side effect profile; high tolerance in elderly patients; rapid action with efficacy often demonstrated in as little 1-2 weeks, which in turn could help improve compliance; its efficacy for treatment of generalized anxiety disorder, which may also be relatively common in patients with diabetes, and co-occurs frequently with depression. This study is designed to test the efficacy of Escitalopram for the treatment of major depression in patients with diabetes mellitus.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Raz Gross, MD; MPH | 972-3-5303962 | razg@gertner.health.gov.il |
Contact: Galit Geulayov, MSc | 972-3-5305180 | galitg@gertner.health.gov.il |
Israel | |
Sheba Medical Center | |
Tel Hashomer, Israel |
Principal Investigator: | Raz Gross, MD; MPH | The Gertner Institute for Epidemiology and Health Policy Research |
Responsible Party: | The Gertner Institute for Epidemiology and Health Policy Research Research ( Dr. Raz Gross ) |
Study ID Numbers: | SHEBA-06-4426-RG-CTIL |
Study First Received: | March 30, 2008 |
Last Updated: | March 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00650897 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Efficacy Antidepressant Escitalopram |
Major Depression Diabetes Mellitus Self Care |
Depression Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Depressive Disorder, Major Depressive Disorder Citalopram Serotonin |
Behavioral Symptoms Mental Disorders Mood Disorders Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Dexetimide |
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 |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |