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

February 28, 2017 updated by: Constantine G. Lyketsos, Johns Hopkins University

Depression in Alzheimer's Disease (DIADS-2)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

131

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • New York
      • Rochester, New York, United States, 14620
        • University of Rochester
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Measured at Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at Weeks 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Constantine G. Lyketsos, MD, MHS, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 25, 2004

First Submitted That Met QC Criteria

June 25, 2004

First Posted (Estimate)

June 28, 2004

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01MH066136 (U.S. NIH Grant/Contract)
  • DATR A4-GPX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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