Preventing Depression Recurrence in Diabetes
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on August 07, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Diabetes
Intervention: sertraline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Official(s) and/or principal investigator(s):
Patrick J Lustman, Ph.D., Principal Investigator, Affiliation: Washington University School of Medicine
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.
Clinical Details
Official title:
Preventing Depression Recurrence in Diabetes
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Detailed description:
Part A: Prevention of Depression Recurrence in Diabetes
1. To determine the efficacy of maintenance antidepressant medication in preventing or delaying recur-rence of major depression in diabetes.
2. 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.
3. To determine clinical features predictive of depression recurrence in diabetes.
Part B. Longitudinal Study of the Interrelationship of Glycemic Control and Depression
1. To determine the effects of depression remission and recurrence on glycemic control.
2. To determine the efficacy of maintenance antidepressant medication in producing sustained benefits in glycemic control.
3. To determine the interrelationship of daily mood with blood glucose and the effect of maintenance treatment on this relationship.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Washington University School of Medicine, St. Louis, Missouri 63110, United States
Additional Information
Starting date:
March 1998
Ending date: October 2004
Last updated: September 8, 2006
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