NCT00650897

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 2, 2008

Status Verified

March 1, 2008

Enrollment Period

1.2 years

First QC Date

March 30, 2008

Last Update Submit

March 30, 2008

Conditions

Major DepressionDiabetes Mellitus

Keywords

EfficacyAntidepressantEscitalopramMajor DepressionDiabetes MellitusSelf Care

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    14 weeks

Secondary Outcomes (1)

  • Diabetes self-care

    14 weeks

Study Arms (1)

A

EXPERIMENTAL

Patients with Diabetes Mellitus and Major Depression

Drug: Escitalopram

Interventions

EscitalopramDRUG

10-20 mg once daily

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Competence: Not competent to understand and sign informed consent forms and/or to understand and answer the evaluations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDiabetes Mellitus

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Raz Gross, MD; MPH

    The Gertner Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raz Gross, MD; MPH

CONTACT

972-3-5303962razg@gertner.health.gov.il

Galit Geulayov, MSc

CONTACT

972-3-5305180galitg@gertner.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 2, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2009

Study Completion

October 1, 2009

Last Updated

April 2, 2008

Record last verified: 2008-03

Locations

IL(1)