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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
Sponsor:
Information provided by (Responsible Party):
Mayer Davidson, Charles Drew University of Medicine and Science

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Depression Drug: sertraline Drug: Placebo Phase 4

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:

  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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo 50 mg up to 100 mg daily for 6 months
Drug: Placebo
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
Drug: sertraline
50 mg up to 100 mg daily for 6 months
Other Name: Zoloft



Primary Outcome Measures :
  1. HbA1C (%) [ Time Frame: Month 0 and month 6 ]
    Change in HbA1C (%) at month 0 and month 6


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mayer Davidson, Professor of Medicine, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00624013     History of Changes
Other Study ID Numbers: 5 U54 RR01616-07
First Posted: February 26, 2008    Key Record Dates
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Mayer Davidson, Charles Drew University of Medicine and Science:
Diabetes
Depression
diabetes outcomes
quality of life

Additional relevant MeSH terms:
Diabetes Mellitus
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs