Clinical trial NCT00086138: Depression in Alzheimer's Disease-2
Official title: Depression in Alzheimer's Disease (DIADS-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alzheimer's Disease
Depression
Keywords: Alzheimer's disease
Depression
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-06-28
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)
timeFrame: Measured at Week 12
Secondary outcomes:
measure: Remission According to Cornell Scale for Depression in Dementia Scale
timeFrame: Measured at Weeks 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: North Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Johns Hopkins University
name: Constantine G. Lyketsos, MD, MHS
role: STUDY_CHAIR
References:
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.
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.
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.