Depression in Alzheimer's Disease-2

Condition(s) targeted: Alzheimer's Disease; Depression

Intervention: Sertraline (Zoloft) (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Constantine G. Lyketsos, MD, MHS, Study Chair, Affiliation: Johns Hopkins University

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.

Official title: Depression in Alzheimer's Disease (DIADS-2)

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.)

Secondary outcome:

Caregiver Burden and Quality of Life

Patient Cognitive Functioning, Quality of Life

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

University of Southern California, Los Angeles, California 90033, United States

Johns Hopkins Hospital, Baltimore, Maryland 21287, United States

University of Rochester, Rochester, New York 14620, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Medical University of South Carolina, North Charleston, South Carolina 29406, United States

Starting date: July 2004
Ending date: July 2009
Last updated: February 19, 2008