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Cited by 248Bipolar Disorder and TreatmentSchizophrenia research and treatmentPsychiatric care and mental health services

Mood stabilisers plus risperidone or placebo in the treatment of acute mania: International, double-blind, randomised controlled trial

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Yatham, Laksami N., Grossman, Fred, Augustyns, Ilse, Vieta, Eduard, Ravindran, Arun·2003·British Journal of Psychiatry
DOI 10.1192/bjp.182.2.141
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Abstract

Background: Few double-blind trials have examined the efficacy of a combination of a mood stabiliser and an atypical antipsychotic in acute mania. Aims: To determine the efficacy of risperidone in combination with a mood stabiliser in acute mania. Method: Patients taking a mood stabiliser were randomised to 3 weeks' treatment with risperidone (n=75) or placebo (n=76). Results: Young Mania Rating Scale (YMRS) scores improved rapidly with significantly greater reductions at week 1 in the risperidone group compared with the placebo group. At end-point YMRS scores decreased by 14.5 and 10.3 points in the risperidone and placebo groups, respectively. Significant improvements v. placebo (P < 0.05) were noted in the risperidone group on several other clinically meaningful measures. Additionally, a post hoc analysis excluding carbamazepine-treated patients (plasma concentrations of risperidone active moiety were 40% lower in this group) revealed significantly greater reductions (P=0.047) in YMRS scores in the risperidone group than in the placebo group. Incidence of adverse events was similar in both groups. Conclusions: Risperidone is superior to placebo when used in combination with lithium or divalproex in acute mania.

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  • Studies of olanzapine or risperidone plus carbamazepine have been negative, probably due to enzyme-inducing effects of carbamazepine.

    “Studies of olanzapine (level 2 negative) 173 or risperidone (level 3 negative)174 plus carbamazepine have been negative, although this is probably due to enzyme‐inducing effects of carbamazepine.”

    From Canadian Network for Mood and Anxiety Treatments ( <scp>CANMAT</scp> ) and International Society for Bipolar Disorders ( <scp>ISBD</scp> ) 2018 guidelines for the management of patients with bipolar disorder (2018) · cites this paper as [174]

    The ‘Effect of carbamazepine on risperidone plasma levels and efficacy’ section says carbamazepine may have blunted risperidone’s effect; the ‘Post hoc analysis’ section reports a significant benefit after carbamazepine-treated patients were excluded. The paper also reports approximately 40% lower risperidone active-moiety levels with carbamazepine. It does not establish that the risperidone–carbamazepine subgroup itself had a negative result or identify enzyme induction as the demonstrated cause; the olanzapine study is cited separately in the sentence. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • There is no evidence that any first-line combination therapy of lithium or divalproex plus an atypical antipsychotic is more effective than other first-line combination therapy.

    “Similarly, there is no evidence that any first‐line combination therapy of lithium or divalproex plus an atypical antipsychotic is more effective than other first‐line combination therapy.174, 193, 213, 214”

    From Canadian Network for Mood and Anxiety Treatments ( <scp>CANMAT</scp> ) and International Society for Bipolar Disorders ( <scp>ISBD</scp> ) 2018 guidelines for the management of patients with bipolar disorder (2018) · cites this paper as [174]

    The introductory passage (page unavailable) says the most appropriate first-line therapy remains debated and that few well-controlled studies have examined combination therapy. That supports uncertainty about treatment choice, but the paper compares risperidone with placebo added to a mood stabiliser; it does not establish that no lithium- or divalproex–atypical antipsychotic combination is more effective than another first-line combination. (LLM, conf=0.72)

    Experimental — accuracy not yet measured

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Authors
Yatham, L. N., Grossman, F., Augustyns, I., Vieta, E., & Ravindran, A.
Affiliations
University of British Columbia (CA)
ORCID
Venue
British Journal of Psychiatry
Publisher
Royal College of Psychiatrists
Published
2003-02
Volume
182
Issue
2
Pages
141-147
ISSN
  • 0007-1250 (ISSN-L)
  • 1472-1465
DOI
10.1192/bjp.182.2.141
OpenAlex
W2179185741
Cited by
248
References
17
Citations by year
2026: 1 · 2025: 1 · 2024: 5 · 2023: 2 · 2022: 4 · 2021: 1 · 2020: 5 · 2019: 3 · 2018: 3 · 2017: 4 · 2016: 5 · 2015: 7 · 2014: 9 · 2013: 8 · 2012: 14
FWCI
18.66
Type
journal article
Language
en
Open access
Licence
www.cambridge.org/core/terms (unspecified, 5449 d)
Locations
  • The British Journal of Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Social Sciences › Psychology › Clinical Psychology › Psychiatric care and mental health services
Keywords
acute mania, risperidone, mood stabilizers, lithium, divalproex, atypical antipsychotics, combination therapy, Young Mania Rating Scale, carbamazepine, bipolar disorder
MeSH terms
Adult, Aged, Basal Ganglia Diseases, Bipolar Disorder, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Lorazepam, Male, Middle Aged, Brief Psychiatric Rating Scale, Psychiatric Status Rating Scales, Antipsychotic Agents, Valproic Acid, Treatment Refusal, Treatment Outcome, Lithium Compounds, Antimanic Agents, Risperidone

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