Randomized, Double-Blind, Placebo-Controlled Study of Paliperidone Extended-Release and Quetiapine in Inpatients With Recently Exacerbated Schizophrenia

Canuso, Carla M.; Dirks, Bryan; Carothers, Jennifer; Kosik‐Gonzalez, Colette; Bossie, Cynthia A.; Zhu, Young; Damaraju, C. V.; Kalali, Amir H; Mahmoud, Ramy

doi:10.1176/appi.ajp.2009.08040613

Cited by 60 publications

(39 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The current population and flexibledose design were chosen to reflect a more representative patient sample treated in a naturalistic setting with treatment that closely resembles day-to-day clinical practice. These data help support results from previously published, fixed-dose, randomized clinical trials [11][12][13][14] . It is important to recognize that concomitant medications, particularly benzodiazepines, and hospitalization may have contributed to some of the benefits, including early response, seen with paliperidone ER.…”

Section: Discussionsupporting

confidence: 87%

“…Benzodiazepines were used by 75-78% of patients in one study 11 ; rescue medications were used by 54-72% of patients in the other two studies, with benzodiazepines reported to be the most commonly used rescue therapies 12,13 . A subsequent 6-week, double-blind, randomized, controlled study with paliperidone ER, quetiapine, or placebo arms was less restrictive by permitting additional psychotropic medication after 2 weeks of initial assigned therapy, with 53% of patients being treated with supplemental therapy, most commonly antipsychotics 14 . Finally, although randomized trials evaluated efficacy starting 4 days after treatment initiation, information on earlier clinical response is important in clinical practice when managing acute schizophrenia, particularly among hospitalized patients as were used in the clinical trials.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Flexible dosing with paliperidone ER in the treatment of patients with acutely exacerbated schizophrenia: results from a single-arm, open-label study

Schmauß

Jukić²,

Siracusano

et al. 2012

Current Medical Research and Opinion

View full text Add to dashboard Cite

These data support findings in more selected patient populations treated with fixed-dose paliperidone ER. Flexibly-dosed paliperidone ER administered in a naturalistic hospital setting to a more representative patient population experiencing an acute episode of schizophrenia, was associated with clinically meaningful treatment response. Strength of conclusions is limited by the open-label design and lack of a comparator group. Furthermore, some of the improvements observed may in part be associated with increased attention provided to patients and concomitant use of psychotropic medications, such as benzodiazepines, during this study.

show abstract

Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Flexible dosing with paliperidone ER in the treatment of patients with acutely exacerbated schizophrenia: results from a single-arm, open-label study

Schmauß

Jukić²,

Siracusano

et al. 2012

Current Medical Research and Opinion

View full text Add to dashboard Cite

show abstract

“…The ziprasidone studies [37][38][39] indicated that somnolence rates were positively correlated to study durations. However, the paliperidone studies did not show a similar correlation between somnolence rates and paliperidone treatment duration [29][30][31][32]. Two maintenance studies [40,41] showed no significant differences in somnolence rates between antipsychotics and placebo ( Table 1).…”

Section: Acute and Maintenance Active Treatment Versus Placebomentioning

confidence: 95%

Antipsychotic Drug-Induced Somnolence: Incidence, Mechanisms, and Management

et al. 2016

View full text Add to dashboard Cite

Somnolence is a common side effect of antipsychotics. To assess the incidence of this side effect, we performed a MEDLINE search for randomized, double-blinded, placebo- or active-controlled studies of adult patients treated with antipsychotics for schizophrenia, mania, bipolar depression, or bipolar disorder. We extracted rates of somnolence from original publications and pooled them based on the dose of each antipsychotic in the same psychiatric condition, then estimated the absolute risk increase (ARI) and the number needed to harm (NNH) of an antipsychotic relative to placebo or an active comparator in the same psychiatric condition. According to the ARI in acute schizophrenia, bipolar mania, and bipolar depression, antipsychotics can be classified as high somnolence (clozapine), moderate somnolence (olanzapine, perphenazine, quetiapine, risperidone, ziprasidone), and low somnolence (aripiprazole, asenapine, haloperidol, lurasidone, paliperidone, cariprazine). The risk of somnolence with blonanserin, brexpiprazole, chlorpromazine, iloperidone, sertindole, and zotepine needs further investigation. The rates of somnolence were positively correlated to dose and duration for some antipsychotics, but not for others. Many factors, including antipsychotic per se, the method used to measure somnolence, patient population, study design, and dosing schedule, might affect the incidence of antipsychotic-induced somnolence. The mechanisms of antipsychotic-induced somnolence are likely multifactorial, although the blockade of histamine 1 receptors and α1 receptors may play a major role. The management of antipsychotic-induced somnolence should include sleep hygiene education, choosing an antipsychotic with a lower risk for somnolence, starting at a lower dose with a slower titration based on psychiatric diagnoses, adjusting doses when necessary, and minimizing concurrent somnolence-prone agents. Since most cases of somnolence were mild to moderate, allowing tolerance to develop over at least 4 weeks is reasonable before discontinuing an antipsychotic.

show abstract

“…Does evidence exist that any medication will reduce hostility in patients With schizophrenia spectrum disorders? 34,48,49,51,52,54,55,[103][104][105][106][107][108][109][110][111][112][113] ( Table 2) Eighteen articles were identified that reported relevant data. No Class I studies were identified that tested this hypothesis.…”

Section: Resultsmentioning

confidence: 99%

Pharmacological Management of Persistent Hostility and Aggression in Persons With Schizophrenia Spectrum Disorders: A Systematic Review

Victoroff

Coburn

Reeve

et al. 2014

JNP

View full text Add to dashboard Cite

The incidence of aggressive behaviors is higher among persons with schizophrenia spectrum disorders (SSDs) than among persons without such disorders. This phenomenon represents a risk to the well-being of patients, their families, and society. The authors undertook a systematic review of the English language literature to determine the efficacy of neuropharmacological agents for the management of hostility and aggression among persons with SSDs. The search combined findings from the Medline, EMBASE, and PsycINFO databases. Ninety-two full text articles were identified that reported relevant findings. The American Academy of Neurology criteria were used to determine levels of evidence. Paliperidone-extended release is probably effective for the management of hostility among inpatients with SSDs who have not been preselected for aggression (Level B). Clozapine is possibly more effective than haloperidol for the management of overt aggression and possibly more effective than chlorpromazine for the management of hostility among inpatients with SSDs who have not been preselected for aggression (Level C). Clozapine is also possibly more effective than olanzapine or haloperidol for reducing aggression among selected physically assaultive inpatients (Level C). Adjunctive propranolol, valproic acid, and famotidine are possibly effective for reducing some aspects of hostility or aggression among inpatients with SSDs (Level C). Paliperidone-extended release currently appears to be the agent for the management of hostility among inpatients with SSDs for which there is the strongest evidence of efficacy.

show abstract

Randomized, Double-Blind, Placebo-Controlled Study of Paliperidone Extended-Release and Quetiapine in Inpatients With Recently Exacerbated Schizophrenia

Abstract: Compared with quetiapine, paliperidone extended-release improved symptoms earlier and to a greater degree in patients with recently exacerbated schizophrenia requiring hospitalization, with no unexpected tolerability findings.

Cited by 60 publications

References 29 publications

Flexible dosing with paliperidone ER in the treatment of patients with acutely exacerbated schizophrenia: results from a single-arm, open-label study

Flexible dosing with paliperidone ER in the treatment of patients with acutely exacerbated schizophrenia: results from a single-arm, open-label study

Antipsychotic Drug-Induced Somnolence: Incidence, Mechanisms, and Management

Pharmacological Management of Persistent Hostility and Aggression in Persons With Schizophrenia Spectrum Disorders: A Systematic Review

Contact Info

Product

Resources

About