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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Constantine G. Lyketsos, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00086138
First received: June 25, 2004
Last updated: September 17, 2013
Last verified: September 2013

June 25, 2004
September 17, 2013
July 2004
July 2008   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00086138 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00086138
U01 MH066136, U01MH066136, DATR A4-GPX
Yes
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
September 2013

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