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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Mood Disorders Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sertraline

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Important dates

Study start: 1998
Study completion: 2004
First posted: Sep 11, 2006
Registry last updated: Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed