Diabetes and Depression in Hispanics and African Americans: Treatment of Depression With Sertraline and Its Effect on A1c and Quality of Life - Full Text View

Sponsor:	Charles Drew University of Medicine and Science
Information provided by:	Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:	NCT00624013

Purpose

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.

Condition	Intervention	Phase
Diabetes Depression	Drug: sertraline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Depression Diabetes

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:

A1c [ Time Frame: 0, 2, 4 6, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

quality of life [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]

Enrollment:	89
Study Start Date:	September 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator	Drug: sertraline 50 mg up to 100 mg daily for 6 months
B: Active Comparator	Drug: sertraline 50 mg up to 100 mg daily for 6 months

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624013

Locations

United States, California
Charles Drew University
Los Angeles, California, United States, 90059

Sponsors and Collaborators

Charles Drew University of Medicine and Science

Investigators

Study Director:

Mayer Davidson, M.D.

Charles Drew University School of Medicine

More Information

No publications provided by Charles Drew University of Medicine and Science

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2009 Sep 3.

Responsible Party:	Charles Drew University School of Medicine and Science ( Diana Echeverry, M.D. )
Study ID Numbers:	5 U54 RR01616-07
Study First Received:	February 15, 2008
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00624013 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Charles Drew University of Medicine and Science:

Diabetes
Depression
diabetes outcomes
quality of life

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diabetes Mellitus
Psychotropic Drugs
Endocrine System Diseases
Depressive Disorder
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Glucose Metabolism Disorders
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010