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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Constantine G. Lyketsos, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00086138
First received: June 25, 2004
Last updated: February 28, 2017
Last verified: February 2017
  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Depression in Alzheimer's Disease (DIADS-2)

Resource links provided by NLM:


Further study details as provided by Constantine G. Lyketsos, Johns Hopkins University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 131
Study Start Date: July 2004
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086138

Locations
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)
Investigators
Study Chair: Constantine G. Lyketsos, MD, MHS Johns Hopkins University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Constantine G. Lyketsos, Chairman, Bayview Psychiatry, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00086138     History of Changes
Other Study ID Numbers: U01MH066136 ( US NIH Grant/Contract Award Number )
DATR A4-GPX
Study First Received: June 25, 2004
Results First Received: March 8, 2016
Last Updated: February 28, 2017

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Alzheimer Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Sertraline
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

ClinicalTrials.gov processed this record on June 21, 2017