Preventing Depression Recurrence in Diabetes - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00374426

Purpose

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.

Condition	Intervention	Phase
Major Depression Diabetes	Drug: sertraline	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Preventing Depression Recurrence in Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Depression

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:	262
Study Start Date:	March 1998
Estimated Study Completion Date:	October 2004

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374426

Locations

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

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Patrick J Lustman, Ph.D.

Washington University School of Medicine

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00374426 History of Changes
Other Study ID Numbers:	96-0806 (completed), DK53060
Study First Received:	September 8, 2006
Last Updated:	March 1, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

depression
diabetes mellitus
depression recurrence

Additional relevant MeSH terms:

Depression
Depressive Disorder
Diabetes Mellitus
Recurrence
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes

Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012