Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.
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|ClinicalTrials.gov Identifier: NCT00624013|
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Depression||Drug: sertraline Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||September 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Placebo Comparator: Placebo
Placebo 50 mg up to 100 mg daily for 6 months
50 mg up to 100 mg daily for 6 months
Active Comparator: Sertraline (Zoloft)
Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months
50 mg up to 100 mg daily for 6 months
Other Name: Zoloft
- HbA1C (%) [ Time Frame: Month 0 and month 6 ]Change in HbA1C (%) at month 0 and month 6
- Quality of Life [ Time Frame: Month 0 and month 6 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624013
|United States, California|
|Charles Drew University|
|Los Angeles, California, United States, 90059|
|Study Director:||Mayer Davidson, M.D.||Charles Drew University School of Medicine|