Clinical trial NCT00624013: Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Depression
Keywords: Diabetes
Depression
diabetes outcomes
quality of life
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
First posted: 2008-02-26
Enrollment: 89
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1C (%)
timeFrame: Month 0 and month 6
Secondary outcomes:
measure: Quality of Life
timeFrame: Month 0 and month 6
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles Drew University
state: California
Study officials:
affiliation: Charles Drew University School of Medicine
name: Mayer Davidson, M.D.
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.2337/dc09-0785. Epub 2009 Sep 3.