Efficacy Study of Escitalopram for Depression in Patients With Diabetes

NCT ID: NCT00650897

Last Updated: 2008-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-10-31

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.

Conditions

Major Depression; Diabetes Mellitus

Keywords

Efficacy; Antidepressant; Escitalopram; Major Depression; Diabetes Mellitus; Self Care

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Patients with Diabetes Mellitus and Major Depression

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

10-20 mg once daily

Interventions

Escitalopram

10-20 mg once daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

The Gertner Institute for Epidemiology and Health Policy Research Research

Principal Investigators

Raz Gross, MD; MPH

Role: PRINCIPAL_INVESTIGATOR

The Gertner Institute

Locations

Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Central Contacts

Raz Gross, MD; MPH

Role: CONTACT

Phone: 972-3-5303962

Email: razg@gertner.health.gov.il

Galit Geulayov, MSc

Role: CONTACT

Phone: 972-3-5305180

Email: galitg@gertner.health.gov.il

Other Identifiers

SHEBA-06-4426-RG-CTIL

Identifier Type: -

Identifier Source: org_study_id