Pharmacological treatment of acute agitation associated with psychotic and bipolar disorder: a systematic review and meta-analysis

Dündar, Yenal; Greenhalgh, J; Richardson, Marty; Dwan, Kerry

doi:10.1002/hup.2535

Cited by 31 publications

(25 citation statements)

References 35 publications

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“…Second‐generation antipsychotics are antipsychotics approved by the Federal Drug Administration for treating agitation associated with schizophrenia and bipolar disorders . However, a frequent side effect associated with these medications that limits their use is weight gain and increased visceral fat, suggesting a potential impact of these drugs on the gut microbiome.…”

Section: Resultsmentioning

confidence: 99%

Systematic review: human gut dysbiosis induced by non‐antibiotic prescription medications

Bastard

Al‐Ghalith

Grégoire

et al. 2017

Aliment Pharmacol Ther

195

126

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Section: Resultsmentioning

confidence: 99%

Systematic review: human gut dysbiosis induced by non‐antibiotic prescription medications

Bastard

Al‐Ghalith

Grégoire

et al. 2017

Aliment Pharmacol Ther

195

126

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“…Another more recent meta-analysis (Meduri et al, 2016) included 16 trials and observational studies of BD, however their analysis focused on the severity of changes in mania and response rates, and did not include subgroup analyses for depression, remission rates or relapse rates. Following these two meta-analyses, another two preliminary meta-analyses have also been published (Dundar et al, 2016;Lindstrom et al, 2017). Of them, the meta-analysis by Dundar et al (2016) focused on pharmacologic treatment for acute agitation but not regular treatment.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

“…Following these two meta-analyses, another two preliminary meta-analyses have also been published (Dundar et al, 2016;Lindstrom et al, 2017). Of them, the meta-analysis by Dundar et al (2016) focused on pharmacologic treatment for acute agitation but not regular treatment. Their results revealed that olanzapine was superior to haloperidol, and that no other treatment, including aripiprazole, was more effective than any other (Dundar et al, 2016).…”

Section: Accepted Manuscriptmentioning

confidence: 99%

“…Of them, the meta-analysis by Dundar et al (2016) focused on pharmacologic treatment for acute agitation but not regular treatment. Their results revealed that olanzapine was superior to haloperidol, and that no other treatment, including aripiprazole, was more effective than any other (Dundar et al, 2016). On the other hand, the meta-analysis by Lindstrom et al (2017), focused on the treatment effect of second-generation antipsychotics in the maintenance phase, and found that aripiprazole was beneficial in preventing relapses (Lindstrom et al, 2017).…”

Section: Accepted Manuscriptmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy, safety and tolerability of aripiprazole in bipolar disorder: An updated systematic review and meta-analysis of randomized controlled trials

Tseng²,

Stubbs

et al. 2017

Progress in Neuro-Psychopharmacology and Biological Psychiatry

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-keung Chow , Efficacy, safety and tolerability of aripiprazole in bipolar disorder: An updated systematic review and meta-analysis of randomized controlled trials. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Pnp(2017Pnp( ), doi: 10.1016Pnp( /j.pnpbp.2017 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.A C C E P T E D M A N U S C R I P T Aripiprazole was associated with lower relapse rates in bipolar mania when used in combination versus a placebo in maintenance therapy (odds ratio: 0.522, p<0.029). ACCEPTED MANUSCRIPT A C C E P T E D M A N U S C R I P TAripiprazole was also associated with higher levels of high density lipoprotein, lower dropout rates, but no difference in extrapyramidal symptoms in the maintenance phase versus a placebo or in comparison with other medications (haloperidol or lithium). Our results suggest that aripiprazole is effective and safe in treating bipolar mania. Further trials are necessary to evaluate the efficacy and tolerability versus other medications.

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“…It is administered by inhalation using the Staccato delivery system. The efficacy of inhaled loxapine for the management of agitation among patients with schizophrenia or bipolar I disorder has been confirmed in placebo-controlled, Phase III trials [15–17] and is supported by indirect comparisons with other antipsychotics [18]. However, head-to-head comparisons with other antipsychotics, including those delivered via IM injection, are lacking.…”

Section: Introductionmentioning

confidence: 99%

Rationale and design of the PLACID study: a randomised trial comparing the efficacy and safety of inhaled loxapine versus IM aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder

et al. 2017

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BackgroundThe management of acute agitation manifesting in patients with schizophrenia or bipolar disorder requires swift pharmacological intervention to provide rapid symptomatic relief and prevent escalation to aggression and violence. Antipsychotic medications are widely used in this setting and the availability of an inhaled formulation with deep lung absorption of the antipsychotic loxapine has the potential to deliver a faster onset of therapeutic effect than the available intramuscular formulations of antipsychotics.MethodsThe efficacy of inhaled loxapine and the alternative antipsychotic aripiprazole delivered via intramuscular (IM) injection will be compared in the Phase IIIb PLACID study. Adults (18–65 years) with a confirmed diagnosis of schizophrenia or bipolar I disorder presenting with acute agitation will be randomly assigned to open-label treatment in a 1:1 ratio. Clinical evaluation will be conducted by raters blinded to treatment assignment. The primary efficacy endpoint is time to response (defined as a Clinical Global Impression of Improvement [CGI-I] score of 1 [very much improved] or 2 [much improved]).Secondary endpoints will include the percentage of responders at different time points after dosing; the proportion of patients who receive 1 or 2 doses of study drug; time to second dose; time to rescue medication; satisfaction with study drug (evaluated using Item 14 of the Treatment Satisfaction Questionnaire for Medication); and safety and tolerability. Approximately 360 patients will be recruited with an interim analysis conducted once 180 patients have completed the study to decide whether to stop for futility or continue with or without an increase in the sample size up to additional 288 patients.DiscussionThe PLACID trial will assess the efficacy and safety of inhaled loxapine with deep lung absorption compared with the IM antipsychotic, aripiprazole, in acutely agitated patients with schizophrenia or bipolar disorder. In the event that the median time to response of inhaled loxapine is significantly shorter than that of the intramuscular aripiprazole, the PLACID study has the potential to support the inhaled antipsychotic therapy as the standard of care in this setting.Trial registrationThe study protocol was registered with the European Clinical Trials Database on the 31 October 2014 (EudraCT number 2014–000456-29).Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-017-1291-5) contains supplementary material, which is available to authorized users.

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Pharmacological treatment of acute agitation associated with psychotic and bipolar disorder: a systematic review and meta-analysis

Cited by 31 publications

References 35 publications

Systematic review: human gut dysbiosis induced by non‐antibiotic prescription medications

Systematic review: human gut dysbiosis induced by non‐antibiotic prescription medications

Efficacy, safety and tolerability of aripiprazole in bipolar disorder: An updated systematic review and meta-analysis of randomized controlled trials

Rationale and design of the PLACID study: a randomised trial comparing the efficacy and safety of inhaled loxapine versus IM aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder

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