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

• Sponsor: Charles Drew University of Medicine and Science (Other)
• Overall Status: Completed
• CT.gov ID: NCT00624013
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Sep 1, 2006
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

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 Names: Zoloft

Outcome Measures

Primary Outcome Measures

1. HbA1C (%) [Month 0 and month 6]

   Change in HbA1C (%) at month 0 and month 6

Secondary Outcome Measures

1. Quality of Life [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayer Davidson, Professor of Medicine, Charles Drew University of Medicine and Science
• ClinicalTrials.gov Identifier: NCT00624013
• Other Study ID Numbers: 5 U54 RR01616-07
• First Posted: Feb 26, 2008
• Last Update Posted: Dec 12, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Professor of Medicine, Charles Drew University of Medicine and Science: Diabetes; Depression; diabetes outcomes; quality of life
• Additional relevant MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder; Sertraline

Study Results

Participant Flow

Recruitment Details	Patients were screened for depression using Whooley's two questions tool at a county diabetes clinic.

Arm/Group Title	Placebo Comparator:Placebo	Active Comparator: Sertraline
Arm/Group Description	Placebo: 50 mg up to 100 mg daily for 6 months	sertraline: 50 mg up to 100 mg daily for 6 months
Period Title: Overall Study
STARTED	44	45
COMPLETED	36	39
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	Placebo Comparator: Placebo	Active Comparator: Sertraline	Total
Arm/Group Description	Placebo: 50 mg up to 100 mg daily for 6 months	sertraline: 50 mg up to 100 mg daily for 6 months	Total of all reporting groups
Overall Participants	44	45	89
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (10)	52 (8)	53 (8)
Sex: Female, Male (Count of Participants)
Female	32 72.7%	33 73.3%	65 73%
Male	12 27.3%	12 26.7%	24 27%
Race/Ethnicity, Customized (participants) [Number]
Hispanic	39 88.6%	39 86.7%	78 87.6%
African American	5 11.4%	5 11.1%	10 11.2%
Region of Enrollment (participants) [Number]
United States	44 100%	45 100%	89 100%

Outcome Measures

1. Primary Outcome

Title	HbA1C (%)
Description	Change in HbA1C (%) at month 0 and month 6
Time Frame	Month 0 and month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Sertraline
Arm/Group Description	Placebo Comparator: 50 mg up to 100 mg daily for 6 months	sertraline: 50 mg up to 100 mg daily for 6 months
Measure Participants	36	39
HbA1C (%) Month 0	9.7 (1.6)	10.0 (1.8)
HbA1C (%) Month 6	8.8 (1.9)	8.0 (1.4)

2. Secondary Outcome

Title	Quality of Life
Description	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.
Time Frame	Month 0 and month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Sertraline (Zoloft)
Arm/Group Description	Placebo 50 mg up to 100 mg daily for 6 months	Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months
Measure Participants	36	39
Overall Quality of Life at Month 0	3.0 (2)	3.5 (3)
Overall Quality of Life at month 6	4.0 (2)	5.0 (3)
Diabetes Severity at Month 0	6.0 (3)	6.0 (3)
Diabetes Severity at Month 6	5.0 (2)	5.0 (2)
Diabetes Control at Month 0	66.7 (18.6)	69.6 (13.4)
Diabetes Control at Month 6	55.7 (17.7)	49.8 (22.0)
Anxiety and Worry at Month 0	76.7 (16.5)	78.8 (12.6)
Anxiety and Worry at Month 6	61.9 (22.1)	57.1 (21.8)
Social Burden at Month 0	63.7 (25.2)	68.2 (17.3)
Social Burden at Month 6	50.4 (23.8)	43.8 (25.8)
Sexual Function at Month 0	66.6 (32.4)	67.8 (28.2)
Sexual Function at Month 6	61.1 (33.2)	56.7 (31.2)
Energy and Mobility at Month 0	63.1 (20.1)	67.6 (16.2)
Energy and Mobility at Month 6	49.7 (22.0)	44.6 (21.1)

Adverse Events

Time Frame	6 months
Arm/Group Title	Placebo		Sertraline
Arm/Group Description	Placebo Comparator: 50 mg up to 100 mg daily for 6 months		sertraline: 50 mg up to 100 mg daily for 6 months
All Cause Mortality
	Placebo		Sertraline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Sertraline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/44 (4.5%)		0/45 (0%)
Psychiatric disorders
Suicidal ideation	1/44 (2.3%)	1	0/45 (0%)	0
Skin and subcutaneous tissue disorders
skin rash	1/44 (2.3%)	1	0/45 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Sertraline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		3/45 (6.7%)
Social circumstances
moved out of the country	1/44 (2.3%)	1	3/45 (6.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.