Preventing Depression Recurrence in Diabetes
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.
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.
Status: Completed (Phase 4). Started on March 1st, 1998.
Enrollment: 262 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double-Blind
- Primary Purpose: Treatment
Conditions:
Interventions:
- Drug: sertraline
Eligibility
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
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
80 Years
- Healthy Volunteers
No
Resources
Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Authority: United States: Federal Government
Locations
-
Washington University School of Medicine
St. Louis
Missouri
63110
United States
Officials
Patrick J Lustman, Ph.D. (Principal Investigator, Washington University School of Medicine)
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- March 1st, 2010
- First Received
- March 1st, 2010
- Last Changed
- March 1st, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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