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Efficacy Study of Escitalopram for Depression in Patients With Diabetes (EFDID)

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: NCT00650897
Recruitment Status : Unknown
Verified March 2008 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 2, 2008
Last Update Posted : April 2, 2008
Information provided by:
Sheba Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depression Diabetes Mellitus Drug: Escitalopram Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Escitalopram Treatment of Major Depression in Diabetes Mellitus: An Open Label
Study Start Date : April 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Patients with Diabetes Mellitus and Major Depression
Drug: Escitalopram
10-20 mg once daily

Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Diabetes self-care [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosis of Type-1 or Type-2 diabetes mellitus (excluding gestational diabetes) by a specialist at least 6 months prior to the study.
  • Current diagnosis of major depression based on DSM-IV criteria .
  • Hamilton Depression Rating Scale (HAMD) baseline score > 17
  • Available for 14-weeks of treatment and all evaluations.
  • Able to understand study rules and procedures and willing to sign written informed consent for study participation.

Exclusion Criteria:

  • Competence: Not competent to understand and sign informed consent forms and/or to understand and answer the evaluations.
  • Psychiatric exclusions: One or more of the following: Alcohol or substance abuse or dependence in past 6 months; psychotic symptoms or history of psychosis; bipolar disorder; organic brain syndrome; significant suicide risk; homicidal thoughts.
  • Medical exclusions: Known intolerance or hypersensitivity to escitalopram or other SSRI; pregnancy; breastfeeding; women of childbearing potential not using adequate contraception; significant renal or hepatic dysfunction (such that demands medical workup and/or regular follow up); resting heart rate less than 40/minute (or 50/minute if symptomatic); uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg); any acute or unstable medical condition that might interfere with the safe conduct of the study.
  • Concomitant medication(s) exclusion: Current use (within 2 weeks of enrollment) of one or more of the following: antidepressants; regular benzodiazepine; neuroleptics; anticonvulsants; reserpine; guanethidine; clonidine; methyldopa.

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 identifier (NCT number): NCT00650897

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Contact: Raz Gross, MD; MPH 972-3-5303962
Contact: Galit Geulayov, MSc 972-3-5305180

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Sheba Medical Center
Tel Hashomer, Israel
Principal Investigator: Raz Gross, MD; MPH         
Sub-Investigator: Ohad Cohen, MD         
Sub-Investigator: Galit Geulayov, MSc         
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Raz Gross, MD; MPH The Gertner Institute

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Responsible Party: Dr. Raz Gross, The Gertner Institute for Epidemiology and Health Policy Research Research Identifier: NCT00650897    
Other Study ID Numbers: SHEBA-06-4426-RG-CTIL
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: April 2, 2008
Last Verified: March 2008
Keywords provided by Sheba Medical Center:
Major Depression
Diabetes Mellitus
Self Care
Additional relevant MeSH terms:
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Diabetes Mellitus
Depressive Disorder
Depressive Disorder, Major
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood 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