The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia
Open accessAbstract
Background: Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic for the treatment of schizophrenia, requires 21 days of oral aripiprazole supplementation upon initiation. We report findings from a phase 1 study investigating a nanocrystalline milled dispersion of AL (AL NCD) as a potential 1-day initiation regimen. The 1-day initiation regimen is designed to enable rapid achievement of plasma aripiprazole concentrations that are comparable with the 21-day oral initiation regimen. Here, a 6-month pharmacokinetic study compared 2 different initiation regimens for starting AL. Methods: Patients were randomized 1:1:1:1 to receive 1 of 4 treatments consisting of the 1-day (single AL NCD injection + one 30-mg dose of oral aripiprazole on day 1 only) or the 21-day (15-mg daily dose of oral aripiprazole for 21 days) initiation regimen, each combined with a starting AL dose of either 441 mg or 882 mg. Results: In total, 133/161 patients completed the study. The pharmacokinetic profile of the 1-day initiation regimen was comparable to the 21-day initiation regimen; both achieved aripiprazole concentrations in the therapeutic range within 4 days and remained in a comparable concentration range during treatment initiation. Common adverse events (≥5.0%) were injection-site pain, headache, increased weight, insomnia, dyspepsia, and anxiety. Nine akathisia events occurred (4 events in 4 patients and 5 events in 2 patients in the 1-day and 21-day initiation regimen groups, respectively). Conclusions: The 1-day initiation regimen resulted in plasma aripiprazole concentrations consistent with the 21-day initiation regimen. Therefore, a single dose of AL NCD with a single 30-mg oral dose of aripiprazole provides an alternative initiation regimen for starting AL.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The cited source says what the claim attributes to it.
In the citing paper
“When aripiprazole lauroxil was first approved, oral supplementation with aripiprazole was recommended for 21 days following initiation [63, 68].”
From Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview (2021) · cites this paper as [68]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Nanosizing: a formulation approach for poorly-water-soluble compounds
Merisko-Liversidge, E. M., Liversidge, G. G., & Cooper, E. R. (2003) · European Journal of Pharmaceutical Sciences · doi:10.1016/s0928-0987(02)00251-8 · Cited by 1,270
Weiden, P. J., Kozma, C., Grogg, A., & Locklear, J. (2004) · Psychiatric Services · doi:10.1176/appi.ps.55.8.886 · Cited by 621
Self-citationHarrison, T. S., & Perry, C. M. (2004) · Drugs · doi:10.2165/00003495-200464150-00010 · Cited by 276
Serum levels of aripiprazole and dehydroaripiprazole, clinical response and side effects
Kirschbaum, K. M., Müller, M. J., Malevani, J., Mobascher, A., Burchardt, C., Piel, M., & Hiemke, C. (2008) · The World Journal of Biological Psychiatry · doi:10.1080/15622970701361255 · Cited by 123
Meltzer, H. Y., Risinger, R. C., Nasrallah, H. A., Du, Y., Zummo, J., Corey, L., Bose, A., Stankovic, S., Silverman, B. L., & Ehrich, E. W. (2015) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.14m09741 · Cited by 116
Self-citationCitrome, L. (2009) · International journal of clinical practice · doi:10.1111/j.1742-1241.2009.02240.x · Cited by 110
Kubo, M., Koue, T., Inaba, A., et al. (2005) · Drug Metabolism and Pharmacokinetics · doi:10.2133/dmpk.20.55 · Cited by 83
Hard, M. L., Mills, R. J., Sadler, B. M., Turncliff, R. Z., & Citrome, L. (2017) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000000691 · Cited by 51
Self-citationAzuma, J., Hasunuma, T., Kubo, M., Miyatake, M., Koue, T., Higashi, K., Fujiwara, T., Kitahara, S., Katano, T., & Hara, S. (2011) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-011-1094-4 · Cited by 48
Hard, M. L., Mills, R. J., Sadler, B. M., Wehr, A. Y., Weiden, P. J., & von Moltke, L. (2017) · CNS Drugs · doi:10.1007/s40263-017-0447-7 · Cited by 44
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Correll, C. U., Kim, E., Sliwa, J. K., Hamm, W., Gopal, S., Mathews, M., Venkatasubramanian, R., & Saklad, S. R. (2021) · CNS Drugs · doi:10.1007/s40263-020-00779-5 · Cited by 205
Metadata
- Authors
- Hard, M. L., Wehr, A. Y., Du, Y., Weiden, P. J., Walling, D., & von Moltke, L.
- Affiliations
- Alkermes (United States) (US)
- Collaborative Neuroscience Network (US)
- Alkermes, Inc, Waltham, MA; and
- Corresponding author
- Hard, Marjie L.
- Wehr, Angela Y.
- Du, Yangchun
- Weiden, Peter J.
- Venue
- Journal of Clinical Psychopharmacology
- Published
- 2018-10
- Volume
- 38
- Issue
- 5
- Pages
- 435-441
- ISSN
- 0271-0749 (ISSN-L)
- 1533-712X
- PMC
- PMC6133194
- OpenAlex
- W2883349192
- Cited by
- 17
- References
- 21
- Citations by year
- 2025: 3 · 2024: 2 · 2023: 2 · 2021: 4 · 2020: 2 · 2019: 3 · 2018: 1
- FWCI
- 1.95
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Clinical Psychopharmacology (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- aripiprazole lauroxil, long-acting injectable antipsychotics, schizophrenia, pharmacokinetics, akathisia, injection site pain
- MeSH terms
- Aripiprazole, Administration, Oral, Adult, Delayed-Action Preparations, Double-Blind Method, Drug Administration Schedule, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Schizophrenia, Antipsychotic Agents, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
