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Melatonin fails to improve sleep or agitation in double-blind randomized placebo-controlled trial of institutionalized patients with Alzheimer disease
Gehrman PR, Connor DJ, Martin JL, Shochat T, Corey-Bloom J, Ancoli-Israel S.. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry, 2009-02-01
Topic: Amyloid, tau and blood-test diagnosis
Objectives Patients with Alzheimer dementia often display both agitated behavior and poor sleep. Given that the disease is often associated with low endogenous levels of melatonin, exogenous melatonin administration may lead to improvements in sleep and agitation. Design Randomized, placebo-controlled study. Setting Nursing homes in San Diego, CA, metropolitan area. Participants Subjects were patients with probable Alzheimer disease. Intervention Melatonin (8.5 mg immediate release and 1.5 mg sustained release) (N = 24) or placebo (N = 17) administered at 10:00 P.M. for 10 consecutive nights. The protocol consisted of baseline (3 days), treatment (10 days), and posttreatment (5 days) phases. Measurements Sleep was measured continuously using actigraphy. Agitation was rated using both the Agitated Behavior Rating Scale and the Cohen-Mansfield Agitation Inventory. Treatment effects were examined both across the 24-hr day and separately by nursing shift. Results There were no significant effects of melatonin, compared with placebo, on sleep, circadian rhythms, or agitation. Conclusion : This study failed to find a beneficial effect of exogenous melatonin, consistent with a number of other studies. The lack of efficacy may be related to the absence of a true treatment effect or to the superphysiologic dose of melatonin used.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Gehrman, P. R., Connor, D. J., Martin, J. L., Shochat, T., Corey-Bloom, J., & Ancoli-Israel, S. (2009). Melatonin fails to improve sleep or agitation in double-blind randomized placebo-controlled trial of institutionalized patients with Alzheimer disease. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. https://doi.org/10.1097/jgp.0b013e318187de18
Vancouver
Gehrman PR, Connor DJ, Martin JL, Shochat T, Corey-Bloom J, Ancoli-Israel S. Melatonin fails to improve sleep or agitation in double-blind randomized placebo-controlled trial of institutionalized patients with Alzheimer disease. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. 2009. doi:10.1097/jgp.0b013e318187de18. PMID: 19155748.
BibTeX
@article{gehrman2009-19155748,
author = {Gehrman, P. R. and Connor, D. J. and Martin, J. L. and Shochat, T. and Corey-Bloom, J. and Ancoli-Israel, S.},
title = {{Melatonin fails to improve sleep or agitation in double-blind randomized placebo-controlled trial of institutionalized patients with Alzheimer disease}},
journal = {The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry},
year = {2009},
doi = {10.1097/jgp.0b013e318187de18},
pmid = {19155748},
url = {https://doi.org/10.1097/jgp.0b013e318187de18}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
Key findings
- Given that the disease is often associated with low endogenous levels of melatonin, exogenous melatonin administration may lead to improvements in sleep and agitation.
- Results There were no significant effects of melatonin, compared with placebo, on sleep, circadian rhythms, or agitation.
Why it matters
In this small trial, melatonin had no significant effect on sleep, circadian rhythms, or agitation in institutionalized patients with Alzheimer disease. This means melatonin did not help these symptoms in this study.
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Study details
- Participants24
- Evidence strengthHigh
How this study scored 67/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry) |
| Journal's citation record | 2 / 4 | American Journal of Geriatric Psychiatry: journal h-index 178 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2009 — within 20 year(s) of the newest study here |
| Sample size | 1 / 4 | 24 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 5 / 7 | Cited 188 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 9.9 citations a year over 19 year(s) since 2009 |
| Impact for its field and year | 3 / 6 | Cited 5.9× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 6 other studies in this library |
| Still being cited | 2 / 4 | Cited 23 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 4 / 4 | Last-listed author Sonia Ancoli‐Israel: h-index 132 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | University of California, Los Angeles: institution h-index 1,923 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 6 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 19155748) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 67 / 100 | — |
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Read the original
- DOI: 10.1097/jgp.0b013e318187de18
- PubMed: 19155748
- Original source →
- Free full text: PubMed Central →
Full text: free to read — PubMed Central lists this copy as free to read: the link above (checked 10 Oct 2026).
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