Back to resultsEfficacy Study of Escitalopram for Depression in Patients With Diabetes (EFDID)
Primary Purpose
Major Depression, Diabetes Mellitus
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Efficacy, Antidepressant, Escitalopram, Major Depression, Diabetes Mellitus, Self Care
Eligibility 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.
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Patients with Diabetes Mellitus and Major Depression
Outcomes
Primary Outcome Measures
Depressive symptoms
Secondary Outcome Measures
Diabetes self-care
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00650897
Brief Title
Efficacy Study of Escitalopram for Depression in Patients With Diabetes
Acronym
EFDID
Official Title
Escitalopram Treatment of Major Depression in Diabetes Mellitus: An Open Label
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Diabetes Mellitus
Keywords
Efficacy, Antidepressant, Escitalopram, Major Depression, Diabetes Mellitus, Self Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Patients with Diabetes Mellitus and Major Depression
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
10-20 mg once daily
Primary Outcome Measure Information:
Title
Depressive symptoms
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Diabetes self-care
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raz Gross, MD; MPH
Phone
972-3-5303962
Email
razg@gertner.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Galit Geulayov, MSc
Phone
972-3-5305180
Email
galitg@gertner.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raz Gross, MD; MPH
Organizational Affiliation
The Gertner Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raz Gross, MD; MPH
First Name & Middle Initial & Last Name & Degree
Ohad Cohen, MD
First Name & Middle Initial & Last Name & Degree
Galit Geulayov, MSc
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Escitalopram for Depression in Patients With Diabetes
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