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Status unknownNCT00650897EFDIDUpdated Apr 2, 2008

Efficacy Study of Escitalopram for Depression in Patients With Diabetes

A Phase 4 interventional study of Escitalopram in Major Depression and Diabetes Mellitus, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-02.

Sponsored by Sheba Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Major Depression
  • Diabetes Mellitus

Keywords

  • Efficacy
  • Antidepressant
  • Escitalopram
  • Major Depression
  • Diabetes Mellitus
  • Self Care
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    A

    Patients with Diabetes Mellitus and Major Depression

    Drug: Escitalopram

Interventions

  • DrugEscitalopram

    10-20 mg once daily

06

What researchers measure

Primary outcomes

  1. Depressive symptoms

    Time frame: 14 weeks

Secondary outcomes

  1. Diabetes self-care

    Time frame: 14 weeks

07

Study locations

1 site
  • Sheba Medical Center
    Tel Hashomer, Israel
    • Raz Gross, MD; MPH · Principal investigator
    • Ohad Cohen, MD · Sub investigator
    • Galit Geulayov, MSc · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00650897
Lead sponsor
Sheba Medical Center
First posted
Apr 2, 2008
Start date
Apr 2008
Primary completion
Jun 2009 (estimated)
Completion
Oct 2009 (estimated)
Last update
Apr 2, 2008

Study contacts

Raz Gross, MD; MPH
Contact
razg@gertner.health.gov.il
972-3-5303962
Galit Geulayov, MSc
Contact
galitg@gertner.health.gov.il
972-3-5305180
Raz Gross, MD; MPH
principal investigator · The Gertner Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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