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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 50 mg up to 100 mg daily for 6 months |
|
| Sertraline (Zoloft) | Active Comparator | Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline | Drug | 50 mg up to 100 mg daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C (%) | Change in HbA1C (%) at month 0 and month 6 | Month 0 and month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mayer Davidson, M.D. | Charles Drew University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles Drew University | Los Angeles | California | 90059 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19729522 | Derived | 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. |
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Patients were screened for depression using Whooley's two questions tool at a county diabetes clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Comparator:Placebo | Placebo: 50 mg up to 100 mg daily for 6 months |
| FG001 | Active Comparator: Sertraline | sertraline: 50 mg up to 100 mg daily for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Comparator: Placebo | Placebo: 50 mg up to 100 mg daily for 6 months |
| BG001 | Active Comparator: Sertraline | sertraline: 50 mg up to 100 mg daily for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Eight subjects from placebo arm A dropped the study and six subjects from active comparator group B dropped from the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1C (%) | Change in HbA1C (%) at month 0 and month 6 | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | Month 0 and month 6 |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Comparator: 50 mg up to 100 mg daily for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| moved out of the country | Social circumstances | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Echeverry, MD, Principal Investigator | Charles Drew University of Medicine and Science | 3235634800 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003863 | Depression |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Placebo | Drug | 50 mg up to 100 mg daily for 6 months |
|
| Month 0 and month 6 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Month 0 and month 6 |
|
|
|
| 2 |
| 44 |
| 1 |
| 44 |
| EG001 | Sertraline | sertraline: 50 mg up to 100 mg daily for 6 months | 0 | 45 | 3 | 45 |
| skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | subject developed skin rash |
|
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Diabetes Severity at Month 0 |
|
| Diabetes Severity at Month 6 |
|
| Diabetes Control at Month 0 |
|
| Diabetes Control at Month 6 |
|
| Anxiety and Worry at Month 0 |
|
| Anxiety and Worry at Month 6 |
|
| Social Burden at Month 0 |
|
| Social Burden at Month 6 |
|
| Sexual Function at Month 0 |
|
| Sexual Function at Month 6 |
|
| Energy and Mobility at Month 0 |
|
| Energy and Mobility at Month 6 |
|