Phase 4 N=89 Randomized Triple-blind Treatment

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

Diabetes · Depression

Bottom Line

View on ClinicalTrials.gov: NCT00624013 ↗

Enrolled (actual)

Serious AEs

2.3%

Results posted

Dec 2017

Primary outcome: Primary: HbA1C (%) — 9.7; 10.0; 8.8; 8.0 Percentage of glycosylated hemoglobin

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: sertraline (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Charles Drew University of Medicine and Science
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY HbA1C (%)	9.7; 10.0; 8.8; 8.0	—
SECONDARY Quality of Life	3.0; 3.5; 4.0; 5.0; 6.0; 6.0	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00624013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.