Preventing Depression Recurrence in Diabetes

Phase 4

Completed

• Conditions: Major Depression; Diabetes

• Registration Number: NCT00374426
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

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.

Study Timeline

• Study Start: 1998-03
• Study Completion: 2004-10
• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-11
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-01
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States