Baltimore, Maryland 21287

  • Depression


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 summary:

Participants are randomly assigned to treatment with sertraline (range 25-125 mg per day) or identical placebo for 24 weeks. There are 8 scheduled in-person visits in the 24 weeks. Visits include neuropsychological testing. Caregivers are asked to are the patient on a Daily Affect Diary for 6 weeks during the study period. Telephone followup is done at weeks 36 and 48. Both groups receive caregiver support/education.


Inclusion: - Ability of the participant, caregiver or surrogate to provide written informed consent. - Dementia due to Alzheimer's disease - Stable treatment for Alzheimer's disease - Ability for the participant's caregiver to accompany the participant to study visits and participate in the study. Exclusion - Presence of a brain disease that might otherwise explain the presence of dementia - Clinically significant hallucinations or delusions - Current treatment of antipsychotics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications - Need for hospitalization or residence in a nursing facility

Study is Available At:

Original ID:

U01 MH066136



Secondary ID:


Study Acronym:


Brief Title:

Depression in Alzheimer's Disease-2

Official Title:

Depression in Alzheimer's Disease (DIADS-2)

Overall Status:


Study Phase:

Phase 2/Phase 3



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Constantine G. Lyketsos, MD, MHS
Study Chair
Johns Hopkins University

Study Dates

Start Date:July 2004
Completion Date:July 2009
Completion Type:Actual
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 17, 2013
First Received Date:June 25, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Depression remission (measured by the Cornell Scale for Depression in Dementia) and a global response measure (mADCS-CGI measuring mood, activity enjoyment, neurovegetative function and depressive cognitions.)
Time Frame:Measured at Week 12
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Caregiver Burden and Quality of Life
Time Frame:Measured at Weeks 24, 36, and 48
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient Cognitive Functioning, Quality of Life
Time Frame:Measured at Weeks 24, 36, and 48
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Sertraline (Zoloft)
Description:Sertraline: range of 25 to 125 mg per day for 24 weeks
Arm Name:1
Intervention Type:Drug
Description:Placebo designed to mimic sertraline taken daily for 24 weeks
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Participants will receive sertraline at a target dose of 100mg daily.
Study Arm Type:Placebo Comparator
Arm Name:2
Description:Participants will receive placebo matched to sertraline

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: April 03, 2020

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