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

Primary Purpose

Alzheimer's Disease, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sertraline (Zoloft)
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California
  • Johns Hopkins Hospital
  • University of Rochester
  • University of Pennsylvania
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Participants will receive sertraline at a target dose of 100mg daily.

Participants will receive placebo matched to sertraline

Outcomes

Primary Outcome Measures

Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)
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
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.

Full Information

First Posted
June 25, 2004
Last Updated
February 28, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00086138
Brief Title
Depression in Alzheimer's Disease-2
Acronym
DIADS-2
Official Title
Depression in Alzheimer's Disease (DIADS-2)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Depression
Keywords
Alzheimer's disease, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive sertraline at a target dose of 100mg daily.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matched to sertraline
Intervention Type
Drug
Intervention Name(s)
Sertraline (Zoloft)
Intervention Description
Sertraline: range of 25 to 125 mg per day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo designed to mimic sertraline taken daily for 24 weeks
Primary Outcome Measure Information:
Title
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)
Description
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".
Time Frame
Measured at Week 12
Secondary Outcome Measure Information:
Title
Remission According to Cornell Scale for Depression in Dementia Scale
Description
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.
Time Frame
Measured at Weeks 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantine G. Lyketsos, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20087081
Citation
Rosenberg PB, Drye LT, Martin BK, Frangakis C, Mintzer JE, Weintraub D, Porsteinsson AP, Schneider LS, Rabins PV, Munro CA, Meinert CL, Lyketsos CG; DIADS-2 Research Group. Sertraline for the treatment of depression in Alzheimer disease. Am J Geriatr Psychiatry. 2010 Feb;18(2):136-45. doi: 10.1097/JGP.0b013e3181c796eb.
Results Reference
result
PubMed Identifier
20672243
Citation
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. doi: 10.1002/gps.2565.
Results Reference
derived
PubMed Identifier
17068314
Citation
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. doi: 10.1097/01.JGP.0000240977.71305.ee.
Results Reference
derived

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Depression in Alzheimer's Disease-2

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