Preventing Depression Recurrence in Diabetes

NCT00374426 | Completed Phase 4

• 2 other identifiers: 96-0806 (completed)DK53060
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Diabetes

Keywords

depression; diabetes mellitus; depression recurrence

Interventions

sertraline DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or Type 2 Diabetes
• Screen positive for depression

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Diabetes Mellitus; Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Patrick J Lustman, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: March 1, 1998
• Study Completion: October 1, 2004
• Last Updated: March 2, 2010

Record last verified: 2010-03

Locations

US (1)