We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00624013
First Posted: February 26, 2008
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mayer Davidson, Charles Drew University of Medicine and Science
Results First Submitted: April 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes
Depression
Interventions: Drug: sertraline
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were screened for depression using Whooley's two questions tool at a county diabetes clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Comparator:Placebo Placebo: 50 mg up to 100 mg daily for 6 months
Active Comparator: Sertraline sertraline: 50 mg up to 100 mg daily for 6 months

Participant Flow:   Overall Study
    Placebo Comparator:Placebo   Active Comparator: Sertraline
STARTED   44   45 
COMPLETED   36   39 
NOT COMPLETED   8   6 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Comparator: Placebo Placebo: 50 mg up to 100 mg daily for 6 months
Active Comparator: Sertraline sertraline: 50 mg up to 100 mg daily for 6 months
Total Total of all reporting groups

Baseline Measures
   Placebo Comparator: Placebo   Active Comparator: Sertraline   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   45   89 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 36   39   75 
   53  (10)   52  (8)   53  (8) 
[1] Eight subjects from placebo arm A dropped the study and six subjects from active comparator group B dropped from the study.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 44   45   89 
Female      32  72.7%      33  73.3%      65  73.0% 
Male      12  27.3%      12  26.7%      24  27.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic       
Participants Analyzed 
[Units: Participants]
 44   45   89 
Hispanic   39   39   78 
African American       
Participants Analyzed 
[Units: Participants]
 44   45   89 
African American   5   5   10 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 44   45   89 
United States   44   45   89 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HbA1C (%)   [ Time Frame: Month 0 and month 6 ]

2.  Secondary:   Quality of Life   [ Time Frame: Month 0 and month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide 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.


Results Point of Contact:  
Name/Title: Diana Echeverry, MD, Principal Investigator
Organization: Charles Drew University of Medicine and Science
phone: 3235634800


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mayer Davidson, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00624013     History of Changes
Other Study ID Numbers: 5 U54 RR01616-07
First Submitted: February 15, 2008
First Posted: February 26, 2008
Results First Submitted: April 13, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017