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

NCT ID: NCT00624013

Last Updated: 2017-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Depression

Keywords

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Diabetes Depression diabetes outcomes quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo 50 mg up to 100 mg daily for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

50 mg up to 100 mg daily for 6 months

Sertraline (Zoloft)

Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months

Group Type ACTIVE_COMPARATOR

sertraline

Intervention Type DRUG

50 mg up to 100 mg daily for 6 months

Interventions

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sertraline

50 mg up to 100 mg daily for 6 months

Intervention Type DRUG

Placebo

50 mg up to 100 mg daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Zoloft

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles Drew University of Medicine and Science

OTHER

Sponsor Role lead

Responsible Party

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Mayer Davidson

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mayer Davidson, M.D.

Role: STUDY_DIRECTOR

Charles Drew University School of Medicine

Locations

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Charles Drew University

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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. doi: 10.2337/dc09-0785. Epub 2009 Sep 3.

Reference Type DERIVED
PMID: 19729522 (View on PubMed)

Other Identifiers

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5 U54 RR01616-07

Identifier Type: -

Identifier Source: org_study_id