Depression in Alzheimer's Disease-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...
Brief Summary
Official Title: “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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: July 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Participants will receive sertraline
- Placebo Comparator: 2
- Participants will receive placebo
Outcome Measures for this Clinical Trial
Primary Measures
- 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
Safety Issue?: Yes
- Time Frame: Measured at Week 12
Secondary Measures
- Caregiver Burden and Quality of Life
- Time Frame: Measured at Weeks 24, 36, and 48
Safety Issue?: No
- Time Frame: Measured at Weeks 24, 36, and 48
- Patient Cognitive Functioning, Quality of Life
- Time Frame: Measured at Weeks 24, 36, and 48
Safety Issue?: No
- Time Frame: Measured at Weeks 24, 36, and 48
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Institute of Mental Health (NIMH) NIH
Overall Clinical Trial Officials and Contacts
Constantine G. Lyketsos, MD, MHS Study Chair Johns Hopkins University
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00086138
Study ID Number: U01 MH066136
ClinicalTrials.gov Identifier: NCT00086138
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00086138
