Baltimore, Maryland 21287

  • Depression

Purpose:

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.


Criteria:

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


NCT ID:

NCT00086138


Secondary ID:

U01MH066136


Study Acronym:

DIADS-2


Brief Title:

Depression in Alzheimer's Disease-2


Official Title:

Depression in Alzheimer's Disease (DIADS-2)


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

131


Enrollment Type:

Actual


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
Name:Placebo
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: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.