Efficacy Study of Escitalopram for Depression in Patients With Diabetes

Diabetes Mellitus Clinical Trial

— EFDID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00650897
• Other study ID #: SHEBA-06-4426-RG-CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 30, 2008
• Last updated: March 30, 2008
• Start date: April 2008
• Est. completion date: October 2009

Study information

• Verified date: March 2008
• Source: Sheba Medical Center
• Contact: Raz Gross, MD; MPH
• Phone: 972-3-5303962
• Email: razg[@]gertner.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Diabetes Mellitus
• Major Depression

Intervention

Drug:
• Escitalopram
10-20 mg once daily

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms		14 weeks	No
Secondary	Diabetes self-care		14 weeks	No