Depression in Alzheimer's Disease-2 - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00086138

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 II Phase III

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia Depression

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will receive sertraline	Drug: Sertraline (Zoloft) Sertraline: range of 25 to 125 mg per day for 24 weeks
Placebo Comparator: 2 Participants will receive placebo	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

National Institute of Mental Health (NIMH)

Investigators

Study Chair:

Constantine G. Lyketsos, MD, MHS

Johns Hopkins University

More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Drye LT, Martin BK, Frangakis CE, Meinert CL, Mintzer JE, Munro CA, Porsteinsson AP, Rabins PV, Rosenberg PB, Schneider LS, Weintraub D, Lyketsos CG; DIADS-2 Research Group. Do treatment effects vary among differing baseline depression criteria in depression in Alzheimer's disease study ± 2 (DIADS-2)? Int J Geriatr Psychiatry. 2011 Jun;26(6):573-83.

Martin BK, Frangakis CE, Rosenberg PB, Mintzer JE, Katz IR, Porsteinsson AP, Schneider LS, Rabins PV, Munro CA, Meinert CL, Niederehe G, Lyketsos CG. Design of Depression in Alzheimer's Disease Study-2. Am J Geriatr Psychiatry. 2006 Nov;14(11):920-30.

Responsible Party:	CONSTANTINE LYKETSOS, MD,MHS, JOHNS HOPKINS UNIVERSITY
ClinicalTrials.gov Identifier:	NCT00086138 History of Changes
Other Study ID Numbers:	U01 MH066136, DATR A4-GPX
Study First Received:	June 25, 2004
Last Updated:	October 13, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

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 February 09, 2012