CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
Sertraline (Zoloft) +1 moredrug
Likely dose
Sertraline 25–125 mg orally once daily for 24 weeksAI-extracted
Key inclusion· 3
  • ✓Confirmed dementia due to Alzheimer's disease
  • ✓Stable treatment for Alzheimer's disease at study entry
  • ✓Participant has a caregiver able to attend visits and participate in the study
Key exclusion· 4
  • ✕Other brain disease that could explain dementia symptoms
  • ✕Clinically significant hallucinations or delusions
  • ✕Current use of antipsychotics, anticonvulsants, other antidepressants, benzodiazepines, or other psychotropic medications
  • ✕Need for hospitalization or nursing facility placement

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

Search/NCT00086138
NCT00086138Phase 3Completed
CompareCT.gov

Depression in Alzheimer's Disease (DIADS-2)

Johns Hopkins University·interventional·Posted Jun 28, 2004·Updated Apr 11, 2017

In Brief

A Phase 3 clinical trial evaluating Sertraline (Zoloft) and Placebo for Alzheimer's Disease and Depression. Completed, enrolled 131 participants across 5 sites.

Detailed Summary

The purpose of this study is to learn whether treating individuals with Alzheimer's disease and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people with Alzheimer's disease and to their families and caregivers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease, Depression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2004
Enrollment StartJul 1, 2004
Primary CompletionJul 1, 2008
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 22.0 years ago

Interventions

Sertraline (Zoloft)drug

Sertraline: range of 25 to 125 mg per day for 24 weeks

Placebodrug

Placebo designed to mimic sertraline taken daily for 24 weeks