Preventing Depression Recurrence in Diabetes

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00374426
First received: September 8, 2006
Last updated: March 1, 2010
Last verified: March 2010
  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 4

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:


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

  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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 July 20, 2014