CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 469 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Sertraline 50-200 mg once dailyAI-extracted
Key inclusion· 3
  • ✓Diagnosis of chronic heart failure
  • ✓Major depression meeting DSM-IV criteria
  • ✓Current use of antipsychotic medication at study entry
Key exclusion· 7
  • ✕Life-threatening comorbidity with ≥50% mortality risk within 1 year
  • ✕History of psychosis, bipolar disorder, or severe personality disorder
  • ✕Alcohol or drug dependence within the past year
  • ✕Severe physical disability interfering with study participation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00078286
NCT00078286Phase 3Completed
CompareCT.gov

Safety and Efficacy of Sertraline for Depression CHF

Duke University·interventional·Posted Feb 24, 2004·Updated Feb 27, 2013

In Brief

A Phase 3 clinical trial evaluating Sertraline and Placebo for Heart Failure, Congestive and 2 related conditions. Completed, enrolled 469 participants across 1 site.

Detailed Summary

This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive, Chronic Heart Failure, Depression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2004
Enrollment StartNov 1, 2003
Primary CompletionMar 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 22.4 years ago

Interventions

Sertralinedrug

Dosage ranging from 50 mg to 200 mg once a day

Placebodrug

Dosage ranging from 50 mg to 200 mg once a day