Preventing Depression Recurrence in Diabetes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374426

Enrollment

262

Registered

2006-09-11

Start date

1998-03-31

Completion date

2004-10-31

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Major Depression

Keywords

depression, diabetes mellitus, depression recurrence

Brief 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.

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.

Interventions

DRUGsertraline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026