Depression in Alzheimer's Disease-2 (DIADS-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00086138
Recruitment Status : Completed
First Posted : June 28, 2004
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Constantine G. Lyketsos, Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Depression Drug: Sertraline (Zoloft) Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depression in Alzheimer's Disease (DIADS-2)
Study Start Date : July 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 1
Participants will receive sertraline at a target dose of 100mg daily.
Drug: Sertraline (Zoloft)
Sertraline: range of 25 to 125 mg per day for 24 weeks

Placebo Comparator: 2
Participants will receive placebo matched to sertraline
Drug: Placebo
Placebo designed to mimic sertraline taken daily for 24 weeks

Primary Outcome Measures :
  1. Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) [ Time Frame: Measured at Week 12 ]
    At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 ("much better") to 7 ("much worse"), with a score of 4 being "no change".

Secondary Outcome Measures :
  1. Remission According to Cornell Scale for Depression in Dementia Scale [ Time Frame: Measured at Weeks 12 ]
    The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00086138

United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, New York
University of Rochester
Rochester, New York, United States, 14620
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
Study Chair: Constantine G. Lyketsos, MD, MHS Johns Hopkins University

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Constantine G. Lyketsos, Chairman, Bayview Psychiatry, Johns Hopkins University Identifier: NCT00086138     History of Changes
Other Study ID Numbers: U01MH066136 ( U.S. NIH Grant/Contract )
U01MH066136 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2004    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: February 2017

Keywords provided by Constantine G. Lyketsos, Johns Hopkins University:
Alzheimer's disease

Additional relevant MeSH terms:
Depressive Disorder
Alzheimer Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs