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

Escitalopram Treatment of Major Depression in Diabetes Mellitus: An Open Label

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus; Major Depression
• Intervention / Treatment: Drug: Escitalopram

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Raz Gross, MD; MPH; Phone Number: 972-3-5303962; Email: razg@gertner.health.gov.il
• Study Contact Backup: Name: Galit Geulayov, MSc; Phone Number: 972-3-5305180; Email: galitg@gertner.health.gov.il

Study Locations

• Israel
  • Tel Hashomer, Israel
    • Sheba Medical Center
    • Principal Investigator: Raz Gross, MD; MPH
    • Sub-Investigator: Ohad Cohen, MD
    • Sub-Investigator: Galit Geulayov, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depressive symptoms	14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Diabetes self-care	14 weeks

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Raz Gross, MD; MPH, The Gertner Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: March 30, 2008
• First Submitted That Met QC Criteria: March 30, 2008
• First Posted (Estimate): April 2, 2008

Study Record Updates

• Last Update Posted (Estimate): April 2, 2008
• Last Update Submitted That Met QC Criteria: March 30, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Efficacy; Diabetes Mellitus; Major Depression; Antidepressant; Escitalopram; Self Care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Mood Disorders; Endocrine System Diseases; Depression; Depressive Disorder; Diabetes Mellitus; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: SHEBA-06-4426-RG-CTIL