Sertraline for the treatment of depression in Alzheimer disease
Open accessAbstract
Objective Depression is common in Alzheimer disease (AD), and antidepressants are commonly used for its treatment, however, evidence for antidepressant efficacy in this population is lacking. The authors conducted a multicenter, randomized, placebo-controlled trial titled "Depression in Alzheimer's Disease-2" to assess the efficacy and tolerability of sertraline for depression in AD.Methods One hundred thirty-one participants from five U.S. medical centers with mild-to-moderate AD (Mini-Mental State Examination scores 10-26) and depression of AD were randomized to double-blinded treatment with sertraline (N = 67) or placebo (N = 64), with a target dosage of 100 mg daily. Efficacy was assessed using logistic regressions and mixed effects models in an intention-to-treat analysis with imputation of missing data. Principal outcome measures were modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC), change in Cornell Scale for Depression in Dementia (CSDD) scores, and remission defined by both mADCS-CGIC score <or=2 and CSDD score <or=6.Results mADCS-CGIC ratings (odd ratio [OR = 1.01], 95% confidence interval [CI]: 0.52-1.97, p = 0.98), CSDD scores (median difference at 12 weeks 1.2, 95% CI: 1.65-4.05, p = 0.41), and remission at 12 weeks of follow-up (OR = 2.06, 95% CI: 0.84-5.04, p = 0.11) did not differ between sertraline (N = 67) and placebo (N = 64). Sertraline-treated patients experienced more adverse events, most notably gastrointestinal and respiratory, than placebo-treated patients.Conclusion Sertraline did not demonstrate efficacy for the treatment depression symptoms in patients with AD. In addition, its use was associated with an increased incidence of adverse events. Thus, selective serotonin reuptake inhibitors may be of limited value for treating depression in patients with AD.
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The method of drug discovery by re-purposing FDA drugs is inherently limited especially in terms of interpreting null results.
“While this method of drug discovery has the attractive feature of studying drugs with generally well-characterized safety profiles, it is inherently limited especially in terms of interpreting null results (Rosenberg et al., 2010).”
From Neuropsychiatric symptoms in Alzheimer's disease: what might be associated brain circuits? (2015) · cites this paper as Rosenberg et al., 2010
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- Authors
- Rosenberg, P. B., Martin, B. K., Frangakis, C., Mintzer, J. E., Weintraub, D., Porsteinsson, A. P., Schneider, L. S., Rabins, P. V., Munro, C. A., Meinert, C. L., Lyketsos, C. G., & Drye, L. T.
- Affiliations
- Johns Hopkins University (US)
- Medical University of South Carolina (US)
- Mental Illness Research, Education and Clinical Centers (US)
- University of Rochester Medicine (US)
- University of Southern California (US)
- Corresponding author
- Rosenberg, Paul B.
- ORCID
- Venue
- The American Journal of Geriatric Psychiatry
- Publisher
- Elsevier BV
- Published
- 2010-02
- Volume
- 18
- Issue
- 2
- Pages
- 136-145
- ISSN
- 1064-7481 (ISSN-L)
- PMC
- PMC2842121
- OpenAlex
- W1983522355
- Cited by
- 250
- References
- 36
- Citations by year
- 2026: 7 · 2025: 10 · 2024: 14 · 2023: 5 · 2022: 14 · 2021: 8 · 2020: 9 · 2019: 14 · 2018: 13 · 2017: 14 · 2016: 11 · 2015: 21 · 2014: 21 · 2013: 24 · 2012: 24
- FWCI
- 19.46
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- American Journal of Geriatric Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (5u01mh068014-05, 5u01mh066176-05, 5u01mh066174-05, 5u01mh066177-05, 5u01mh066175-05)
- National Institute on Aging (K08AG029157, P50AG005142, P50AG005146)
- National Institute of Mental Health (U01 MH068014, U01 MH066174, 1U01MH066175, 1U01MH068014, U01MH066177, 1U01MH066177, 1U01MH066176, U01 MH066175, 1U01MH066174, U01 MH066176, U01MH066136)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Keywords
- sertraline, Alzheimer's disease, depression, selective serotonin reuptake inhibitors, antidepressant efficacy, adverse events, depression remission, Cornell Scale for Depression in Dementia, mild to moderate dementia
- MeSH terms
- Assessment of Medication Adherence, Aged, Alzheimer Disease, Depression, Double-Blind Method, Female, Humans, Male, Patient Dropouts, Placebos, Treatment Outcome, Drug Monitoring, Selective Serotonin Reuptake Inhibitors, Sertraline, Medication Adherence
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