Preventing Depression Recurrence in Diabetes

Diabetes Clinical Trial

Official title:

Preventing Depression Recurrence in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374426
• Other study ID #: 96-0806 (completed)
• Secondary ID: DK53060
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2006
• Last updated: March 1, 2010
• Start date: March 1998
• Est. completion date: October 2004

Study information

• Verified date: March 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Diabetes
• Major Depression
• Recurrence

Intervention

Drug:
• sertraline

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States,