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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00086138

First received: June 25, 2004

Last updated: October 13, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 25, 2004

Last Updated Date

October 13, 2008

Start Date ^ICMJE

July 2004

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00086138 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Depression in Alzheimer's Disease-2

Official Title ^ICMJE

Depression in Alzheimer's Disease (DIADS-2)

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease
Depression

Intervention ^ICMJE

Drug: Sertraline (Zoloft)
Sertraline: range of 25 to 125 mg per day for 24 weeks
Drug: Placebo
Placebo designed to mimic sertraline taken daily for 24 weeks

Study Arm (s)

Experimental: 1
Participants will receive sertraline

Intervention: Drug: Sertraline (Zoloft)
Placebo Comparator: 2
Participants will receive placebo

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

131

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00086138

Other Study ID Numbers ^ICMJE

U01 MH066136, DATR A4-GPX

Has Data Monitoring Committee

Yes

Responsible Party

CONSTANTINE LYKETSOS, MD,MHS, JOHNS HOPKINS UNIVERSITY

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Constantine G. Lyketsos, MD, MHS

Johns Hopkins University

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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