Preventing Depression Recurrence in Diabetes
This study has been completed.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First received: September 8, 2006
Last updated: March 1, 2010
Last verified: March 2010
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Preventing Depression Recurrence in Diabetes
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Type 1 or Type 2 Diabetes
- Screen positive for depression
- 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
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
|Washington University School of Medicine
|St. Louis, Missouri, United States, 63110 |
||Patrick J Lustman, Ph.D.
||Washington University School of Medicine
No publications provided
History of Changes
|Other Study ID Numbers:
||96-0806 (completed), DK53060
|Study First Received:
||September 8, 2006
||March 1, 2010
||United States: Federal Government
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Depressive Disorder, Major
Glucose Metabolism Disorders
Endocrine System Diseases