Preventing Depression Recurrence in Diabetes
Primary Purpose
Major Depression, Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sertraline
Sponsored by

About this trial
This is an interventional treatment trial for Major Depression focused on measuring depression, diabetes mellitus, depression recurrence
Eligibility Criteria
Inclusion Criteria:
- 18-80
- Type 1 or Type 2 Diabetes
- Screen positive for depression
Exclusion Criteria:
- Are pregnant or lactating
- Are known to be hypersensitive to the drug
- Have a recent history of myocardial infarction or unstable heart disease
- Have severe hepatic disease or renal impairment (serum creatinine > 3 mg/dl)
- The subset of patients with psychiatric disorders thought to affect management (e.g., schizophrenia, alcohol and drug dependence) will also be excluded from participation
Sites / Locations
- Washington University School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00374426
First Posted
September 8, 2006
Last Updated
March 1, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00374426
Brief Title
Preventing Depression Recurrence in Diabetes
Official Title
Preventing Depression Recurrence in Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
Brief Summary
To study the effectiveness of sertraline (Zoloft) in treating depression in adults with diabetes. The study will also determine whether depressed diabetic patients who have successfully responded to sertraline (Zoloft) are more likely to have depression recur if the sertraline (Zoloft) is discontinued.
Detailed Description
Part A: Prevention of Depression Recurrence in Diabetes
To determine the efficacy of maintenance antidepressant medication in preventing or delaying recur-rence of major depression in diabetes.
To determine the relationship of sustained depression remission to social, occupational, and global func-tioning, and to quality of life and compliance with diabetes treatment.
To determine clinical features predictive of depression recurrence in diabetes.
Part B. Longitudinal Study of the Interrelationship of Glycemic Control and Depression
To determine the effects of depression remission and recurrence on glycemic control.
To determine the efficacy of maintenance antidepressant medication in producing sustained benefits in glycemic control.
To determine the interrelationship of daily mood with blood glucose and the effect of maintenance treatment on this relationship.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Diabetes
Keywords
depression, diabetes mellitus, depression recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
262 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sertraline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-80
Type 1 or Type 2 Diabetes
Screen positive for depression
Exclusion Criteria:
Are pregnant or lactating
Are known to be hypersensitive to the drug
Have a recent history of myocardial infarction or unstable heart disease
Have severe hepatic disease or renal impairment (serum creatinine > 3 mg/dl)
The subset of patients with psychiatric disorders thought to affect management (e.g., schizophrenia, alcohol and drug dependence) will also be excluded from participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J Lustman, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preventing Depression Recurrence in Diabetes
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