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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Constantine G. Lyketsos, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00086138
First received: June 25, 2004
Last updated: September 17, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Caregiver Burden and Quality of Life [ Time Frame: Measured at Weeks 24, 36, and 48 ] [ Designated as safety issue: No ]
  • Patient Cognitive Functioning, Quality of Life [ Time Frame: Measured at Weeks 24, 36, and 48 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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
Investigators
Study Chair: Constantine G. Lyketsos, MD, MHS Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional 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: U01 MH066136, U01MH066136, DATR A4-GPX
Study First Received: June 25, 2004
Last Updated: September 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Alzheimer's disease
Depression

Additional relevant MeSH terms:
Alzheimer Disease
Depression
Depressive Disorder
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014