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CompletedNCT00374426Updated Mar 2, 2010

Preventing Depression Recurrence in Diabetes

A Phase 4 interventional study of sertraline in Major Depression and Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-03-02.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
262
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Major Depression
  • Diabetes

Keywords

  • depression
  • diabetes mellitus
  • depression recurrence
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 262 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-80
  • Type 1 or Type 2 Diabetes
  • Screen positive for depression

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
262 participants

Interventions

  • Drugsertraline
06

Study locations

1 site
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00374426
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted
Sep 11, 2006
Start date
Mar 1998
Completion
Oct 2004
Last update
Mar 2, 2010

Study contacts

Patrick J Lustman, Ph.D.
principal investigator · Washington University School of Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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