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



Status:Completed
Conditions:Depression, Depression, Diabetes
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:21 - Any
Updated:12/14/2017
Start Date:September 2006
End Date:October 2008

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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.

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.
We found this trial at
1
site
Los Angeles, California 90059
?
mi
from
Los Angeles, CA
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