NCT00624013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Sep 2006

Typical duration for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

December 12, 2017

Completed
Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

2.1 years

First QC Date

February 15, 2008

Results QC Date

April 13, 2017

Last Update Submit

November 9, 2017

Conditions

DiabetesDepression

Keywords

DiabetesDepressiondiabetes outcomesquality of life

Outcome Measures

Primary Outcomes (1)

  • HbA1C (%)

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

    Month 0 and month 6

Secondary Outcomes (1)

  • Quality of Life

    Month 0 and month 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 50 mg up to 100 mg daily for 6 months

Drug: Placebo

Sertraline (Zoloft)

ACTIVE COMPARATOR

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

Drug: sertraline

Interventions

sertralineDRUG

50 mg up to 100 mg daily for 6 months

Also known as: Zoloft
Sertraline (Zoloft)
PlaceboDRUG

50 mg up to 100 mg daily for 6 months

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Drew University

Los Angeles, California, 90059, United States

Location

Related Publications (1)

  • 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.

    PMID: 19729522DERIVED

MeSH Terms

Conditions

Diabetes MellitusDepression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Diana Echeverry, MD, Principal Investigator
Organization
Charles Drew University of Medicine and Science
3235634800

Study Officials

  • Mayer Davidson, M.D.

    Charles Drew University School of Medicine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 26, 2008

Study Start

September 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 12, 2017

Results First Posted

December 12, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)