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

Depression Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624013
• Other study ID #: 5 U54 RR01616-07
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2008
• Last updated: November 9, 2017
• Start date: September 2006
• Est. completion date: October 2008

Study information

• Verified date: November 2017
• Source: Charles Drew University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• sertraline
50 mg up to 100 mg daily for 6 months
• Placebo
50 mg up to 100 mg daily for 6 months

Locations

Country	Name	City	State
United States	Charles Drew University	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C (%)	Change in HbA1C (%) at month 0 and month 6	Month 0 and month 6
Secondary	Quality of Life	Quality of life (QOL) was assed at baseline and at month 6 using validated instrument Diabetes-39 Quality of Life Questionnaire. It consists of 39-item questionnaire designed to help us learn more about what affects the quality of life of people with diabetes in five dimensions of patients' lives: Diabetes Control, Anxiety and Worry, Social Burden, Sexual Functioning and Energy and Mobility. The Diabetes-39 questionnaire uses a Not Affected At All -Extremely Affected point scale score ranging from 1-7. Raw scale scores were transformed to a 0-100 scale using a linear transformation. Higher values represent a worse outcome. Overall rating of Quality-of-Life was assessed using a Lowest quality-Highest quality scale ranging from 1-7. Higher values represent an increase or improvement in overall QOL. Pattern of Diabetes Severity was measured with a Not Severe at all-Extremely Severe scale ranging from 1-7. Higher values represent increase in diabetes severity.	Month 0 and month 6