Phase 3
Completed N=131
Depression in Alzheimer's Disease-2
Source: ClinicalTrials.gov NCT00086138 ↗Enrolled (actual)
131
Serious AEs
15.3%
Results posted
Apr 2017
Primary outcomePrimary: Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) — 1; 0; 5; 2 participants — p=0.98
◆ Published Evidence
Highly cited
247citations · ~15 / year
Sertraline for the treatment of depression in Alzheimer disease.
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.
Linked Publications (3)
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Sertraline for the treatment of depression in Alzheimer disease.
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Do treatment effects vary among differing baseline depression criteria in depression in Alzheimer's disease study ± 2 (DIADS-2)?
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Design of Depression in Alzheimer's Disease Study-2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) |
1; 0; 5; 2; 6; 9 | 0.98 |
| SECONDARY Remission According to Cornell Scale for Depression in Dementia Scale |
33; 19 | 0.11 |
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
Data sourced from ClinicalTrials.gov (NCT00086138) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.