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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086138
First Posted: June 28, 2004
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Constantine G. Lyketsos, Johns Hopkins University
June 25, 2004
June 28, 2004
March 8, 2016
April 11, 2017
April 11, 2017
July 2004
July 2008   (Final data collection date for primary outcome measure)
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".
Not Provided
Complete list of historical versions of study NCT00086138 on ClinicalTrials.gov Archive Site
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.
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Depression in Alzheimer's Disease-2
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Depression
  • 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
  • Experimental: 1
    Participants will receive sertraline at a target dose of 100mg daily.
    Intervention: Drug: Sertraline (Zoloft)
  • Placebo Comparator: 2
    Participants will receive placebo matched to sertraline
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
July 2009
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00086138
U01MH066136( U.S. NIH Grant/Contract )
U01MH066136 ( U.S. NIH Grant/Contract )
DATR A4-GPX
Yes
Not Provided
Not Provided
Constantine G. Lyketsos, Johns Hopkins University
Johns Hopkins University
National Institute of Mental Health (NIMH)
Study Chair: Constantine G. Lyketsos, MD, MHS Johns Hopkins University
Johns Hopkins University
February 2017

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