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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00650897
First received: March 30, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Escitalopram Treatment of Major Depression in Diabetes Mellitus: An Open Label

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes self-care [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650897

Contacts
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

Locations
Israel
Sheba Medical Center Not yet recruiting
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
Investigators
Principal Investigator: Raz Gross, MD; MPH The Gertner Institute for Epidemiology and Health Policy Research
  More Information

No publications provided

Responsible Party: Dr. Raz Gross, The Gertner Institute for Epidemiology and Health Policy Research Research
ClinicalTrials.gov Identifier: NCT00650897     History of Changes
Other Study ID Numbers: SHEBA-06-4426-RG-CTIL
Study First Received: March 30, 2008
Last Updated: March 30, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Efficacy
Antidepressant
Escitalopram
Major Depression
Diabetes Mellitus
Self Care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 01, 2014