CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Escitalopram +2 moredrug
Likely dose
Escitalopram 10 mg orally once or twice daily for 6 monthsAI-extracted
Key inclusion· 4
  • English-speaking
  • African American ethnicity
  • Type 2 diabetes per American Diabetes Association criteria
  • Receiving care at Grady Hospital
Key exclusion· 9
  • Severely depressed (HAM-D ≥34)
  • Bipolar disorder, schizophrenia, psychotic disorder, OCD, or cognitive/developmental disorder (DSM-IV criteria)
  • Active suicide risk or serious suicide attempt in past year
  • Substance abuse or dependence (excluding nicotine) in past 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00209170
NCT00209170Phase 4Completed

Depression-Diabetes Mechanisms: Urban African Americans

Emory University·interventional·Posted Sep 21, 2005·Updated Jul 29, 2015

In Brief

A Phase 4 clinical trial evaluating Beating the Blues, Escitalopram, and 1 other intervention for Diabetes and Depression. Completed, enrolled 20 participants across 1 site.

Detailed Summary

African-Americans suffer from increased prevalence of both type 2 diabetes and diabetes complications, reflecting a combination of psychobehavioral factors as well as metabolic dysfunction. In this process, depression may contribute to both the genesis of type 2 diabetes (through impact on neurohormonal activation, inflammatory mediators, and insulin resistance), and difficulties in management (through decreased adherence to diet plans, medication, and scheduled appointments). The preliminary data from the Grady Diabetes Clinic indicates that depression may be common in African-Americans with diabetes, that depression is a factor in non-adherence, and that non-adherence leads to poor glycemic control - a direct cause of diabetes complications. What is not known is: how treatment of depression could lead to both neurohormonal and psychobiological improvement, with improved patient adherence and glycemic control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Depression
CountriesUnited States

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartMay 1, 2004
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.8 years ago

Interventions

Beating the Bluesbehavioral

Beating the Blues is a computerized cognitive behavioral therapy.

Escitalopramdrug

Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months.

Placebodrug

A sugar pill taken as one to two tablets daily for 6 months.