Depression in Alzheimer's Disease-2 (DIADS-2)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00086138
First received: June 25, 2004
Last updated: October 13, 2008
Last verified: October 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Depression |
Drug: Sertraline (Zoloft) Drug: Placebo |
Phase 2 Phase 3 |
| 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 |
| Official Title: | Depression in Alzheimer's Disease (DIADS-2) |
Resource links provided by NLM:
Further study details as provided by National Institute of Mental Health (NIMH):
Primary Outcome 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 131 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive sertraline
|
Drug: Sertraline (Zoloft)
Sertraline: range of 25 to 125 mg per day for 24 weeks
|
|
Placebo Comparator: 2
Participants will receive placebo
|
Drug: Placebo
Placebo designed to mimic sertraline taken daily for 24 weeks
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086138
Locations
| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14620 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| North Charleston, South Carolina, United States, 29406 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Constantine G. Lyketsos, MD, MHS | Johns Hopkins University |
More Information
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | CONSTANTINE LYKETSOS, MD,MHS, JOHNS HOPKINS UNIVERSITY |
| ClinicalTrials.gov Identifier: | NCT00086138 History of Changes |
| Other Study ID Numbers: | U01 MH066136, DATR A4-GPX |
| Study First Received: | June 25, 2004 |
| Last Updated: | October 13, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Alzheimer's disease Depression |
Additional relevant MeSH terms:
|
Alzheimer Disease Depression Depressive Disorder Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Behavioral Symptoms Mood Disorders |
Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013