Diabetes and Depression in Hispanics and African Americans: Treatment of Depression With Sertraline and Its Effect on A1c and Quality of Life (DandD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Charles Drew University of Medicine and Science.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00624013
First received: February 15, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted

February 15, 2008
February 15, 2008
September 2006
October 2008   (final data collection date for primary outcome measure)
A1c [ Time Frame: 0, 2, 4 6, 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
quality of life [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Diabetes and Depression in Hispanics and African Americans: Treatment of Depression With Sertraline and Its Effect on A1c and Quality of Life
The Effects of Pharmacologic Treatment of Depression on Glycated Hemoglobin, Lipids and Quality of Life in Underserved Hispanics and African Americans With Diabetes: A Randomized, Placebo Controlled Trial

This proposed study will test the following hypothesis: Treating depression in Hispanics and African Americans with diabetes will improve their HbA1c and quality of life while on intervention and six months after intervention.

The medication to be used will be sertraline (Zoloft). Sertraline (Zoloft)has been proven in clinical trials to be an effective and well tolerated prescription medication that improves the quality and enjoyment of life for adults suffering from depression . Sertraline is an antidepressant and a member of the family of medications known as selective serotonin reuptake inhibitors (SSRIs). It has excellent tolerability and minimal drug-drug intereactions.

The hypothesis will be tested by the following specific aims:

  1. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves HbA1c.
  2. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves quality of life.

If our hypothesis proves correct and this treatment of depression is efficient and easy in a county hospital population of African Americans and Hispanics, researchers can move forward in finding fast and efficient means of diagnosing depression in vulnerable populations, including low-literate patients. This study is critical in that it stands to improve the HBA1c (and other metabolic parameters) and quality of life of our underserved minority community, which sadly suffers from a higher rate of almost every disease, including diabetes. Treating mild to moderate depression in a county hospital population of African Americans and Hispanics may improve quality of life and reduce/prevent complications and early death. Secondary outcomes include reduced hospitalizations, fewer missed appointments, and improved adherence to medication.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes
  • Depression
Drug: sertraline
50 mg up to 100 mg daily for 6 months
Other Name: Zoloft
  • Placebo Comparator: A
    Intervention: Drug: sertraline
  • Active Comparator: B
    Intervention: Drug: sertraline
Echeverry D, Duran P, Bonds C, Lee M, Davidson MB. Effect of pharmacological treatment of depression on A1C and quality of life in low-income Hispanics and African Americans with diabetes: a randomized, double-blind, placebo-controlled trial. Diabetes Care. 2009 Dec;32(12):2156-60. Epub 2009 Sep 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
89
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients (men, women) who are African American or Hispanic over the age of 21 who have been diagnosed with type 2 diabetes and have a HbA1c of greater than 8.0%. Subjects with neuropathic pain will be included in the study. Their pain will be assessed via a validated pain scale. Their primary care providers will treat their pain as necessary.

Exclusion Criteria:

  • Pregnant women, patients on dialysis, patients with liver disease or liver enzymes elevated three times above normal, patients with blood pressure greater than 160 systolic or 95 diastolic on two consecutive visits, patients with history of severe depression (as determined by hospitalization or the HAM-D survey) or suicide attempts, patients on therapy for depression, patients already taking SSRI's, and patients with psychotic features or bipolar disease.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00624013
5 U54 RR01616-07
Yes
Diana Echeverry, M.D., Charles Drew University School of Medicine and Science
Charles Drew University of Medicine and Science
Not Provided
Study Director: Mayer Davidson, M.D. Charles Drew University School of Medicine
Charles Drew University of Medicine and Science
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP