CoChat
Sign Up
Cited by 27Schizophrenia research and treatmentTreatment of Major DepressionHistorical Psychiatry and Medical Practices

Maintenance therapy with once-monthly administration of long-acting injectable risperidone in patients with schizophrenia or schizoaffective disorder: a pilot study of an extended dosing interval

Open access
Gharabawi, Georges M, Gearhart, Natalie C, Lasser, Robert A, Mahmoud, Ramy A, Zhu, Young, Mannaert, Erik, Naessens, Ineke, Bossie, Cynthia A +2 more·2007·Annals of General Psychiatry
DOI 10.1186/1744-859x-6-3
Open this paper in CoChat — free accountOpen PDF

Abstract

Background: Several clinical studies have established the efficacy, safety, and tolerability of long-acting risperidone administered once every 2 weeks in patients with schizophrenia or schizoaffective disorder. This report evaluates preliminary efficacy, safety, tolerability, and pharmacokinetic data for a novel (once-monthly) administration of long-acting injectable risperidone 50 mg in patients with schizophrenia or schizoaffective disorder. Methods: Clinically stable patients participated in a 1-year, open-label, single-arm, multicenter pilot study. During the 4-week lead-in phase, patients received long-acting risperidone 50 mg injections every 2 weeks, with 2 weeks of oral risperidone supplementation. Injections of long-acting risperidone 50 mg every 4 weeks followed for up to 48 weeks, without oral supplementation. The primary endpoint was relapse; other assessments included PANSS, CGI-S, adverse event reports, and determination of risperidone and 9-hydroxyrisperidone plasma concentrations. Results: Twelve patients in the intent-to-treat population (n = 67) met relapse criteria (17.9%). Relapse risk at 1 year was estimated as 22.4%. Non-statistically significant improvements in symptoms (PANSS) and clinical status (CGI-S) at endpoint were observed. The most common adverse events included schizophrenia aggravated not otherwise specified (19.5%), anxiety (16.1%), insomnia (16.1%), and headache (11.5%). There were no unexpected safety and tolerability findings. Mean plasma concentrations for risperidone and 9-hydroxyrisperidone were generally stable during the study. Conclusion: Once-monthly dosing of long-acting risperidone was well tolerated, associated with a relatively low relapse rate (similar to that reported with other antipsychotics), and maintained the clinically stable baseline status of most patients. Although the results suggest that some symptomatically stable patients with schizophrenia or schizoaffective disorder might be safely managed with long-acting risperidone 50 mg once monthly, these findings alone do not identify which patients will have a sufficient therapeutic benefit nor do they quantify comparative effects of standard and altered dosing. Study limitations (the open-label pilot study design, small sample size, and lack of a concurrent biweekly treatment arm) prevent broad interpretations and extrapolations of results. Controlled studies would be required to support a recommendation for alternative dosing regimens.

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.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1186/1744-859x-6-3

Cites

21 of 21 references verified0 citation errors · 0 not checkable

Statistics

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.

A few free checks a day · papers already verified open instantly · results are public

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?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 3

  1. Eerdekens M, Van Hove I, Remmerie B, Mannaert E: Pharmacoki- netics and tolerability of long-acting risperidone in schizo- phrenia. Schizophr Res 2004, 70:91-100.
  2. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders: DSM-IV-TR. text revision 4th edition. Washington, DC: American Psychiatric Association; 2000.
  3. Chouinard G, Ross-Chouinard A, Annable L: Extrapyramidal Symptom Rating Scale. Can J Neurolog Sci 1980, 7:233.

Cited by

Sorted by citations

Related

Authors
Gharabawi, G. M., Gearhart, N. C., Lasser, R. A., Mahmoud, R. A., Zhu, Y., Mannaert, E., Naessens, I., Bossie, C. A., Kujawa, M., & Simpson, G. M.
Affiliations
  • Janssen Scientific Affairs (United States) (US)
  • Janssen (Belgium) (BE)
  • University of Southern California (US)
Corresponding author
Kujawa, Mary
ORCID
Venue
Annals of General Psychiatry
Publisher
Springer Science and Business Media LLC
Published
2007-01-29
Volume
6
Issue
1
Pages
3-3
ISSN
1744-859X (ISSN-L)
DOI
10.1186/1744-859x-6-3
OpenAlex
W1523943650
Cited by
27
References
21
Citations by year
2025: 2 · 2023: 1 · 2021: 1 · 2020: 2 · 2019: 1 · 2017: 1 · 2016: 1 · 2015: 2 · 2014: 1 · 2013: 2 · 2012: 4
FWCI
1.21
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Annals of General Psychiatry (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
University of Texas Health Science Center at San Antonio
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Clinical Psychology › Historical Psychiatry and Medical Practices
Keywords
long-acting injectable risperidone, schizophrenia, schizoaffective disorder, maintenance therapy, extended dosing interval, relapse prevention, antipsychotic pharmacokinetics, paliperidone, adverse events, tolerability, PANSS, CGI-S, insomnia

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