Preventing Depression Recurrence in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Study Completion Date

2004-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Depression in Alzheimer's Disease-2

NCT00086138

Alzheimer's Disease Depression

COMPLETED PHASE2/PHASE3

Treatment Outcome of Vascular Depression

NCT00045773

Depressive Disorder Depression

COMPLETED

The Depression in Alzheimer's Disease Study (DIADS)

NCT00009191

Alzheimer Disease Depression

COMPLETED PHASE4

Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

NCT00177424

Cerebrovascular Accident Depression

TERMINATED PHASE4

Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight

NCT00834652

Depression

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depression Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sertraline

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No