NCT00624013

Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Charles Drew University of Medicine and Science · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes
• Depression

Interventions

Type	Name	Description
DRUG	sertraline	50 mg up to 100 mg daily for 6 months
DRUG	Placebo	50 mg up to 100 mg daily for 6 months

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-02-26
• Last updated: 2017-12-12
• Results posted: 2017-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study