Depression in Alzheimer's Disease-2

Depression Clinical Trial

— DIADS-2  

Official title:

Depression in Alzheimer's Disease (DIADS-2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086138
• Other study ID #: U01MH066136
• Secondary ID: U01MH066136DATR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 25, 2004
• Last updated: September 17, 2013
• Start date: July 2004
• Est. completion date: July 2009

Study information

• Verified date: September 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Depression
• Depressive Disorder

Intervention

Drug:
• Sertraline (Zoloft)
Sertraline: range of 25 to 125 mg per day for 24 weeks
• Placebo
Placebo designed to mimic sertraline taken daily for 24 weeks

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Southern California	Los Angeles	California
United States	Medical University of South Carolina	North Charleston	South Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)		Measured at Week 12	Yes
Secondary	Caregiver Burden and Quality of Life		Measured at Weeks 24, 36, and 48	No
Secondary	Patient Cognitive Functioning, Quality of Life		Measured at Weeks 24, 36, and 48	No