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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Major Depression
• Intervention / Treatment: Drug: sertraline

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 Type: Interventional
• Enrollment: 262
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Patrick J Lustman, Ph.D., Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 1998
• Study Completion: October 1, 2004

Study Registration Dates

• First Submitted: September 8, 2006
• First Submitted That Met QC Criteria: September 8, 2006
• First Posted (Estimate): September 11, 2006

Study Record Updates

• Last Update Posted (Estimate): March 2, 2010
• Last Update Submitted That Met QC Criteria: March 1, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: depression; diabetes mellitus; depression recurrence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Mood Disorders; Endocrine System Diseases; Disease Attributes; Depression; Depressive Disorder; Diabetes Mellitus; Recurrence; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: 96-0806 (completed); DK53060