A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia

Pandina, Gahan; Lane, Rosanne; Gopal, Srihari; Gassmann-Mayer, Cristiana; Hough, David; Remmerie, Bart; Simpson, George M.

doi:10.1016/j.pnpbp.2010.11.008

Cited by 150 publications

(123 citation statements)

References 26 publications

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“…The results of studies that compared one LAI versus another are summarized in Table 3. [76][77][78][79][80] Although symptom improvement and relapse rates are generally similar with different LAIs, differences Abbreviations: AE = adverse event, ARI = aripiprazole, BL = baseline, BMI = body mass index, BPRS = Brief Psychiatric Rating Scale, BZD = benzodiazepine, CGI-C = Clinical Global Impressions-Change score, DB = double-blind, Dx = diagnosis, eq = equivalent, Hp = hospitalization, IM = intramuscular, Int. = international, LAI = long-acting injectable antipsychotic, N = study population, n = randomized number, NR = not reported, OL = open label, OLA = olanzapine, PANSS = Positive and Negative Syndrome Scale, PBO = placebo, PC = placebo-controlled, PP = paliperidone palmitate, RIS = risperidone, SCZ = schizophrenia, Tx = treatment, USA = United States of America, w/ = with.…”

Section: Efficacy Of Lais Versus Placebo Versus Oral Antipsychoticsmentioning

confidence: 99%

The Use of Long-Acting Injectable Antipsychotics in Schizophrenia

Correll¹,

Citrome²,

Haddad³

et al. 2016

J. Clin. Psychiatry

287

276

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Section: Efficacy Of Lais Versus Placebo Versus Oral Antipsychoticsmentioning

confidence: 99%

The Use of Long-Acting Injectable Antipsychotics in Schizophrenia

Correll¹,

Citrome²,

Haddad³

et al. 2016

J. Clin. Psychiatry

287

276

View full text Add to dashboard Cite

“…22 Long-acting injectable therapies, such as once-monthly paliperidone palmitate (paliperidone monthly), provide consistent therapeutic plasma concentrations over several weeks, eliminating the need for daily oral medication and facilitating monitoring of treatment adherence. 23,24 Building on efficacy data of oral paliperidone in acute management of schizoaffective disorder, 5,6 this relapse-prevention study was designed to compare paliperidone monthly given as monotherapy or with adjunctive antidepressants or mood stabilizers to placebo in patients with schizoaffective disorder.…”

mentioning

confidence: 99%

Paliperidone Palmitate Once-Monthly Reduces Risk of Relapse of Psychotic, Depressive, and Manic Symptoms and Maintains Functioning in a Double-Blind, Randomized Study of Schizoaffective Disorder

Fu¹,

Turkoz²,

Simonson³

et al. 2014

J. Clin. Psychiatry

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Objective: Schizoaffective disorder is a complex illness for which optimal treatment is not well established. Results of the first controlled, relapse-prevention study of paliperidone palmitate once-monthly injectable (paliperidone monthly) in schizoaffective disorder are presented. Method:The study was conducted between September 20, 2010, and October 22, 2013. Patients with schizoaffective disorder (confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders) experiencing acute exacerbation of psychotic and depressive/manic symptoms were stabilized with paliperidone monthly as monotherapy or as adjunctive therapy to mood stabilizers or antidepressants and randomly assigned (1:1) to paliperidone monthly or placebo in a 15-month, double-blind, relapse-prevention phase. Randomization was stratified by administration as monotherapy or adjunctive therapy and by study center. The primary endpoint was time to relapse.Results: 334 patients were evaluated. Paliperidone monthly significantly delayed time to relapse for psychotic, depressive, and manic symptoms compared with placebo (P < .001, log-rank test). Relapse risk was 2.49 times greater for placebo (hazard ratio = 2.49; 95% CI, 1.55 to 3.99; P < .001, Cox proportional hazards model). Overall relapse rates were 33.5% for placebo and 15.2% for paliperidone monthly. For monotherapy, relapse risk was 3.38 times greater with placebo (P = .002), and for adjunctive treatment it was 2.03 times greater with placebo (P = .021). Paliperidone monthly was superior to placebo in maintaining functioning as measured by the Personal and Social Performance scale (P = .014, mixed-model repeated-measures analysis). The most common adverse events (placebo, paliperidone monthly) were increased weight (4.7%, 8.5%), insomnia (7.1%, 4.9%), schizoaffective disorder (5.9%, 3.0%), headache (3.5%, 5.5%), and nasopharyngitis (3.5%, 5.5%). Incidence of any extrapyramidal-related adverse event was 7.1% for placebo and 8.5% for paliperidone monthly.Conclusions: Paliperidone monthly as monotherapy or adjunctive therapy significantly delayed psychotic, depressive, and/or manic relapses; reduced their risk; and better maintained functioning in patients with schizoaffective disorder. Results support the value of maintenance treatment with paliperidone monthly in schizoaffective disorder.Trial Registration: ClinicalTrials.gov identifier: NCT01193153 Clin Psychiatry 2015;76(3):253-262 J

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“…16 For those with a previous response to oral paliperidone or risperidone, paliperidone palmitate LAI may be used without prior stabilisation with oral treatment as long as psychotic symptoms are mild to moderate and an LAI is needed. 16 Paliperidone palmitate has demonstrated non-inferiority when compared with risperidone LAI 17 and a Cochrane review concluded that in short-term studies paliperidone palmitate was more efficacious than placebo. 18 As discussed above, paliperidone palmitate LAI was compared with haloperidol decanoate in the ACLAIMS study, 11 which demonstrated comparable efficacy between the two LAIs.…”

Section: Paliperidone Palmitate Lai (Xeplion ® )mentioning

confidence: 99%

A review of the efficacy and tolerability of antipsychotic long-acting injections

Whyte¹,

Parker²

2016

Prog. Neurol. Psychiatry

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The formulation of long‐acting injections (LAIs) as a method of delivering antipsychotics can be used to improve adherence, particularly in those unintentionally non‐adherent. Here, the authors review the efficacy and tolerability of first‐generation antipsychotic (FGA) and second‐generation antipsychotic (SGA) LAIs, analyse drug cost, give guidance on initiation regimens for SGA LAIs and discuss the future for these drugs.

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A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia

Cited by 150 publications

References 26 publications

The Use of Long-Acting Injectable Antipsychotics in Schizophrenia

The Use of Long-Acting Injectable Antipsychotics in Schizophrenia

Paliperidone Palmitate Once-Monthly Reduces Risk of Relapse of Psychotic, Depressive, and Manic Symptoms and Maintains Functioning in a Double-Blind, Randomized Study of Schizoaffective Disorder

A review of the efficacy and tolerability of antipsychotic long-acting injections

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