- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00624013
Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.
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 Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- 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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90059
- Charles Drew University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo 50 mg up to 100 mg daily for 6 months
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1C (%)
Time Frame: Month 0 and month 6
|
Change in HbA1C (%) at month 0 and month 6
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Month 0 and month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Month 0 and month 6
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Collaborators and Investigators
Investigators
- Study Director: Mayer Davidson, M.D., Charles Drew University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Glucose Metabolism Disorders
- Metabolic Diseases
- Mood Disorders
- Endocrine System Diseases
- Depression
- Depressive Disorder
- Diabetes Mellitus
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- 5 U54 RR01616-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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