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:
To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves HbA1c.
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.
Status: Active, not recruiting (Phase 4). Started on September 1st, 2006. Ended on October 1st, 2008.
Enrollment: 89 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Double Blind (Subject
- Investigator
- Outcomes Assessor)
- Placebo Control
- Parallel Assignment
Conditions:
Interventions:
- Drug: sertraline (Zoloft)
Eligibility
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.
- Gender
Both
- Mininum Age
21 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Charles Drew University of Medicine and Science
Authority: United States: Institutional Review Board
Locations
-
Charles Drew University
Los Angeles
California
90059
United States
Officials
Mayer Davidson, M.D. (Study Director, Charles Drew University School of Medicine)
Sponsors
Charles Drew University of Medicine and Science (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- February 1st, 2008
- First Received
- February 15th, 2008
- Last Changed
- February 15th, 2008
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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