Overview

This trial is active, not recruiting.

Conditions diabetes, depression
Treatment sertraline
Phase phase 4
Sponsor Charles Drew University of Medicine and Science
Start date September 2006
End date October 2008
Trial size 89 participants
Trial identifier NCT00624013, 5 U54 RR01616-07

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.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
sertraline Zoloft
50 mg up to 100 mg daily for 6 months
(Active Comparator)
sertraline Zoloft
50 mg up to 100 mg daily for 6 months

Primary Outcomes

Measure
A1c
time frame: 0, 2, 4 6, 12 months

Secondary Outcomes

Measure
quality of life
time frame: 0, 6, 12 months

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Charles Drew University of Medicine and Science.