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Usefulness of plasma haloperidol levels for monitoring clinical efficacy and side effects in Alzheimer patients with psychosis and behavioral dyscontrol
Pelton GH, Devanand DP, Bell K, Marder K, Marston K, Liu X, Cooper TB.. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry, 2003-03-01
Topic: Amyloid, tau and blood-test diagnosis
Objective This study investigated whether measurement of plasma levels may be useful in monitoring clinical efficacy and side effects during oral haloperidol (HL) treatment of psychosis and behavioral dyscontrol in patients with Alzheimer disease (AD). Methods After a single-blind placebo period of 1 week, 71 outpatients with AD were randomized to a 6-week, double-blind, placebo-controlled trial of HL 2 mg-3 mg/day (standard dose), HL 0.5 mg-0.75 mg/day (low dose), or placebo, with plasma levels for HL drawn at the end of 6 weeks. Results Of the 40 patients who received active HL for 6 weeks, 35 had plasma levels drawn. Plasma levels were all below the lower limit of the postulated therapeutic range in schizophrenia. Nonetheless, HL plasma level significantly correlated with clinical efficacy as measured by reduction in Brief Psychiatric Rating Scale Total score, Psychosis factor, and Hostile-Suspiciousness factor, the Behavioral Syndromes Scale for Dementia Psychomotor Agitation scale, and with the severity of extrapyramidal side effects (EPS). Oral dose did not significantly correlate with any of these efficacy or side-effect measures. Plasma levels significantly correlated with HL dose. When both HL dose and HL plasma level were included as independent variables in linear-regression analyses, only HL plasma level was a significant predictor of efficacy and EPS. Conclusion Measurement of HL plasma levels may have potential usefulness as an adjunct in monitoring treatment response to oral HL in AD patients with psychosis or disruptive behavior.
Key findings
- Results Of the 40 patients who received active HL for 6 weeks, 35 had plasma levels drawn.
- Nonetheless, HL plasma level significantly correlated with clinical efficacy as measured by reduction in Brief Psychiatric Rating Scale Total score, Psychosis factor, and Hostile-Suspiciousness factor, the Behavioral Syndromes Scale for Dementia Psychomotor Agitation scale, and with the severity of extrapyramidal side effects (EPS).
- Oral dose did not significantly correlate with any of these efficacy or side-effect measures.
- Plasma levels significantly correlated with HL dose.
- When both HL dose and HL plasma level were included as independent variables in linear-regression analyses, only HL plasma level was a significant predictor of efficacy and EPS.
Why it matters
In this 6-week trial of 71 outpatients with Alzheimer's disease, haloperidol plasma levels correlated with clinical efficacy on several measures and with extrapyramidal side effects, while oral dose did not. It concerns monitoring an antipsychotic used for psychosis and behavioral symptoms, not treating, curing or preventing Alzheimer's disease itself.
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Study details
- Participants40
- Evidence strengthHigh
How this study scored 51/100
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. We have no data on journal's citation record, so that was left out: it earned 49 of the 96 points we could judge it on, which is 51 out of 100.
| 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 | — / 4 | No journal record from OpenAlex — left out of this score |
| 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 | 2003 — older than 20 years, still counted |
| Sample size | 1 / 4 | 40 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 | 1 / 7 | Cited 4 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.2 citations a year over 25 year(s) since 2003 |
| Impact for its field and year | 1 / 6 | Cited 0.6× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 0 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Gregory H. Pelton: h-index 42 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Columbia University: institution h-index 1,824 (OpenAlex) |
| Multi-centre collaboration | 1 / 3 | OpenAlex lists 2 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 12611748) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 49 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 49 of the 96 points we could judge it on is 51 out of 100. |
| Total | 51 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
May need a subscription Unpaywall, Europe PMC and OpenAlex found no free copy of the full text (checked 10 Oct 2026), so the publisher may charge for it. The PubMed abstract is free.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
APA 7th
Pelton, G. H., Devanand, D. P., Bell, K., Marder, K., Marston, K., Liu, X., et al. (2003). Usefulness of plasma haloperidol levels for monitoring clinical efficacy and side effects in Alzheimer patients with psychosis and behavioral dyscontrol. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. https://doi.org/10.1176/appi.ajgp.11.2.186
Vancouver
Pelton GH, Devanand DP, Bell K, Marder K, Marston K, Liu X, et al. Usefulness of plasma haloperidol levels for monitoring clinical efficacy and side effects in Alzheimer patients with psychosis and behavioral dyscontrol. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. 2003. doi:10.1176/appi.ajgp.11.2.186. PMID: 12611748.
BibTeX
@article{pelton2003-12611748,
author = {Pelton, G. H. and Devanand, D. P. and Bell, K. and Marder, K. and Marston, K. and Liu, X. and Cooper, T. B.},
title = {{Usefulness of plasma haloperidol levels for monitoring clinical efficacy and side effects in Alzheimer patients with psychosis and behavioral dyscontrol}},
journal = {The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry},
year = {2003},
doi = {10.1176/appi.ajgp.11.2.186},
pmid = {12611748},
url = {https://doi.org/10.1176/appi.ajgp.11.2.186}
}
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