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Effect of Pharmacological Treatment of Depression on A1C 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.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Charles Drew University
Los Angeles, California, United States
Start Date
September 1, 2006
Primary Completion Date
October 1, 2008
Completion Date
October 1, 2008
Last Updated
December 12, 2017
89
ACTUAL participants
sertraline
DRUG
Placebo
DRUG
Lead Sponsor
Charles Drew University of Medicine and Science
NCT00001987
NCT07360600
Data Source & Attribution
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