paliperidone-palmitate and Dyskinesia--Drug-Induced

The aim of this paper is to present a case of paliperidone-induced Pisa syndrome and provide treatment experience.. The case report is combined with a review of the literature.. A 37-year-old man had been diagnosed with paranoid-type schizophrenia for about 10 years. He received three-month treatment of paliperidone extended release (ER) at 6 mg per day, but showed a progressively Pisa-like physical position. We initially added an anticholinergic drug, but saw no improvement. The paliperidone ER was replaced by olanzapine at 10 mg per day, and the Pisa-like symptom improved after 1 month of the drug replacement.. We propose olanzapine as a possible replacement choice for patients with paliperidone-related Pisa syndrome.

Topics: Adult; Antipsychotic Agents; Benzodiazepines; Dyskinesia, Drug-Induced; Dystonia; Humans; Male; Olanzapine; Paliperidone Palmitate; Psychiatric Status Rating Scales; Schizophrenia, Paranoid; Syndrome

Topics: Animals; Antipsychotic Agents; Clozapine; Drug Administration Routes; Dyskinesia, Drug-Induced; Humans; Paliperidone Palmitate; Psychotic Disorders

Oculogyric crises are considered to be a form of focal dystonia and can be observed as reactions to pharmaceuticals. The signs and symptoms may be confused with epileptic crises.. To describe the clinical features and progress of patients with pharmaceutical-related oculogyric crises and to carry out a review of the topic.. We conducted a retrospective, descriptive study of four patients evaluated in the neurology service due to oculogyric crises. The patients had been diagnosed with an associated conduct disorder requiring treatment with antipsychotic drugs. The episodes of oculogyric crises did not correlate with the findings in the electroencephalogram. They responded well to the reduction in dosage or to withdrawal of the apparent causing agent.. The clinical picture does not present only in patients treated with antipsychotics but is also linked with other pharmaceuticals that are frequently used in daily paediatric practice. When oculogyric crises are the reason for visiting, differential diagnoses must be taken into account in order to avoid unnecessary studies and to carry out an appropriate therapeutic management.

Topics: Adolescent; Anticonvulsants; Antipsychotic Agents; Aripiprazole; Child; Child Behavior Disorders; Child, Preschool; Dopamine; Dopamine Antagonists; Down Syndrome; Dyskinesia, Drug-Induced; Dystonic Disorders; Electroencephalography; Epilepsy; Female; Fragile X Syndrome; Humans; Intellectual Disability; Isoxazoles; Male; Methotrimeprazine; Ocular Motility Disorders; Paliperidone Palmitate; Piperazines; Pyrimidines; Quinolones; Risperidone; Substance Withdrawal Syndrome; Translocation, Genetic; Valproic Acid

Paliperidone, the active metabolite of risperidone is a relatively recent introduction for the treatment of schizophrenia. There is paucity of data regarding the use of paliperidone in elderly patients. We have attempted to highlight the prominent aspects of the use of paliperidone in the geriatric population. The limited data indicate that paliperidone may be effective and safe in the treatment of schizophrenia in the elderly.

Topics: Age Factors; Aged; Clinical Trials as Topic; Dyskinesia, Drug-Induced; Humans; Isoxazoles; Nervous System Diseases; Paliperidone Palmitate; Pyrimidines; Schizophrenia

It has been proposed that relapse rates after antipsychotic discontinuation may be artificially inflated and that some of these symptom recurrences may be due to rebound or withdrawal phenomena rather than due to illness recurrence.. Post hoc analysis of data from a relapse-prevention study (conducted from March 2005 to February 2007) of paliperidone palmitate once-monthly (PP1M) versus placebo was conducted to compare the nature of operationally defined relapse events in schizophrenia patients (diagnosed by DSM-IV criteria) experiencing relapses after randomization to placebo (n = 97) with those in patients receiving maintenance PP1M treatment (n = 36). These 2 groups were compared for onset and severity of recurrence symptoms, symptom profiles at relapse, and postrelapse treatment response. Psychological and physiological signs of discontinuation and signs of antipsychotic tolerance, dyskinesia, and prolactin elevation that might indicate dopamine receptor supersensitivity were compared.. Both groups were similar in terms of relapse symptom profiles, onset and severity of relapse symptoms, and postrelapse treatment response. The Positive and Negative Syndrome Scale total score (mean ± SD) for placebo versus maintenance treatment group at baseline was 54.5 ± 11.74 vs 54.1 ± 11.64 and at relapse was 75.6 ± 16.79 vs 75.2 ± 17.23 (P = .9). No elevated blood pressure or heart rate, dyskinesia, antipsychotic tolerance, or elevated prolactin in the patients relapsing after antipsychotic discontinuation was noted.. Findings suggest that relapses after treatment discontinuation reflect recurrence of the underlying illness and may be consistent with a hypothesis of direct relationship between dopamine and psychosis. No evidence was obtained for withdrawal-related phenomena contributing to the high relapse rates after treatment discontinuation.. ClinicalTrials.gov identifier: NCT00111189.

Topics: Adolescent; Adult; Aged; Antipsychotic Agents; Double-Blind Method; Drug Tolerance; Dyskinesia, Drug-Induced; Female; Humans; Male; Middle Aged; Paliperidone Palmitate; Prolactin; Recurrence; Schizophrenia; Withholding Treatment; Young Adult

This study was to evaluate the effects on clinical symptoms and cognitive function of switching the treatment of elderly patients with schizophrenia from risperidone to paliperidone (PAL).. This study was a 12-weeks, preliminary open-label trial. The subjects were 17 inpatients. Their extrapyramidal symptoms (EPS) were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS), Abnormal Involuntary Movement Scale (AIMS), and Barnes Akathisia Scale (BAS), and their cognitive function was assessed using the Brief Assessment Cognition in Schizophrenia: Japanese language version (BACS-J), and their clinical symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity of illness scale (CGI-S) at the 0 and 12 weeks.. The DIEPSS and BAS significantly improved after switching from risperidone to PAL. Furthermore, improvement was found on AIMS. The mean change from baseline in z-score of the digit sequencing task was significantly increased. All items on the PANSS and CGI-S were not significant; however, changes in some cognitive function were correlated with changes in EPS.. The results of this study suggest the possibility that switching elderly patients from risperidone to PAL may have improved pre-existing EPS, and may also have helped improve working memory.

Topics: Aged; Akathisia, Drug-Induced; Antipsychotic Agents; Cognition Disorders; Drug Substitution; Dyskinesia, Drug-Induced; Female; Humans; Isoxazoles; Male; Memory, Short-Term; Neuropsychological Tests; Paliperidone Palmitate; Psychiatric Status Rating Scales; Pyrimidines; Risperidone; Schizophrenia; Severity of Illness Index; Treatment Outcome

This open-label, rater-blinded, parallel-group study was designed to evaluate noninferiority of paliperidone palmitate (PP), a once-monthly injectable atypical antipsychotic, to once-biweekly risperidone long-acting injectable (RIS-LAI) in adult Chinese patients with acute schizophrenia. Eligible Chinese adults (N=452) with schizophrenia were randomized (1:1) to either PP (N=229; deltoid injections on day 1 [150 mg eq.] and day 8 [100 mg eq.]; then once-monthly deltoid or gluteal injections, flexibly dosed [50, 100, or 150 mg eq.]), or RIS-LAI (N=223; once-biweekly gluteal injections, flexibly dosed [25, 37.5 or 50 mg]). RIS-LAI-treated patients received oral risperidone supplementation (1-6 mg/day) at initiation and with RIS-LAI dose increases. Mean (SD) Positive and Negative Syndrome Scale (PANSS) total score at baseline was 83.2 (12.44). Mean (SD) change from baseline to endpoint in PANSS total scores (primary efficacy measure) was: -23.6 (16.28) for PP group and -26.9 (15.43) for RIS-LAI group. PP was noninferior to RIS-LAI (least squares mean difference [95% CI]: -2.3 [-5.20; 0.63]; predetermined non-inferiority margin: -5.5). Mean (SD) change from baseline to endpoint in Clinical Global Impression-Severity scale score was: -1.5 (1.24; PP group), -1.7 (1.16; RIS-LAI group) and in Personal and Social Performance Scale scores was: 16.8 (14.76; PP group), 18.6 (13.92; RIS-LAI group). The incidence of treatment-emergent adverse events (TEAEs) was similar between the two groups (73% [PP]; 75% [RIS-LAI]). The most common TEAEs were akathisia, tremor, and insomnia. The study demonstrated the noninferiority of PP (50-150 mg eq., flexibly dosed, without oral paliperidone supplementation) to risperidone-LAI (25-50 mg, flexibly dosed, with oral risperidone supplementation) for the treatment of acute schizophrenia in adult Chinese patients. PP injections were generally tolerable, and no new safety signals were detected in this population.

Topics: Adolescent; Adult; Antipsychotic Agents; Data Interpretation, Statistical; Delayed-Action Preparations; Diagnostic and Statistical Manual of Mental Disorders; Double-Blind Method; Dyskinesia, Drug-Induced; Endpoint Determination; Female; Glucose; Heart Diseases; Humans; Injections, Intramuscular; Isoxazoles; Male; Middle Aged; Paliperidone Palmitate; Palmitates; Prolactin; Psychiatric Status Rating Scales; Risperidone; Sample Size; Schizophrenia; Schizophrenic Psychology; Suicide; Treatment Outcome; Young Adult

Paliperidone extended-release tablet (paliperidone ER) is an investigational oral psychotropic developed for schizophrenia treatment. It utilizes OROS technology to provide a unique pharmacokinetic profile, eliminating the need for titration and potentially leading to improved tolerability. Furthermore, paliperidone undergoes limited hepatic metabolism.. The efficacy and safety of once-daily paliperidone ER (6 mg, 9 mg and 12 mg) were assessed versus placebo in 628 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study.. All doses of paliperidone ER demonstrated significant improvement in PANSS score, all PANSS Marder factor scores (p<0.001) and personal and social functioning versus placebo (p<0.001). The PANSS total score also improved significantly in the olanzapine treatment arm. Significantly higher percentages of paliperidone ER patients demonstrated a > or =30% reduction in PANSS total score versus placebo (p<0.001). The incidence of movement disorder-related AEs and rating scales measurements were similar to placebo for the paliperidone ER 6 mg group and higher in the 9 mg and 12 mg groups. In the paliperidone ER groups there were no reports of glucose-related AEs or clinically relevant changes in plasma lipid levels and changes in mean bodyweight<1 kg.. In this study, all doses of paliperidone ER were effective in significantly improving the symptoms of schizophrenia and personal and social functioning and were generally well tolerated. Paliperidone ER offers a distinctive treatment profile and may provide a valuable new treatment option for patients with schizophrenia.

Topics: Adult; Antipsychotic Agents; Delayed-Action Preparations; Dose-Response Relationship, Drug; Drug-Related Side Effects and Adverse Reactions; Dyskinesia, Drug-Induced; Female; Humans; Isoxazoles; Male; Middle Aged; Paliperidone Palmitate; Patient Dropouts; Psychiatric Status Rating Scales; Pyrimidines; Randomized Controlled Trials as Topic; Schizophrenia; Schizophrenic Psychology; Sleep Initiation and Maintenance Disorders; Tachycardia; Treatment Outcome

Paliperidone extended-release tablet (paliperidone ER) is an oral psychotropic agent developed for schizophrenia treatment. Paliperidone (9-OH-risperidone, metabolite of risperidone), when used with OROS technology has a unique pharmacokinetic profile undergoing limited hepatic metabolism.. The efficacy and safety of once-daily paliperidone ER (3 mg, 9 mg and 15 mg) were compared with placebo in 618 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study. An assay sensitivity group with known efficacy was included to confirm trial validity (olanzapine 10 mg).. All doses of paliperidone ER demonstrated significant improvements in PANSS total and PANSS factors scores (p<0.05) and in personal and social functioning (p<0.001) compared with placebo. Symptom improvement has been observed at the first observation assessment (Day 4) (p<0.001) compared with placebo, suggesting a rapid onset of action for paliperidone ER. Paliperidone ER was associated with a low incidence of treatment-emergent adverse events. The incidence of movement disorder-related adverse events and rating scale scores were similar in the paliperidone ER 3 mg and placebo groups and increased with dose. Increases in prolactin plasma levels and dose-related increases in body weight (<2 kg) were observed; there were no significant changes in serum lipid or glucose levels.. In this study, all doses of paliperidone ER were effective in significantly improving the symptoms of schizophrenia and personal and social functioning and were generally well tolerated. As such, paliperidone ER may provide a valuable new treatment option for patients with schizophrenia.

Topics: Administration, Oral; Adult; Antipsychotic Agents; Blood Glucose; Body Weight; Delayed-Action Preparations; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions; Dyskinesia, Drug-Induced; Female; Humans; Isoxazoles; Lipids; Male; Middle Aged; Neurologic Examination; Paliperidone Palmitate; Psychiatric Status Rating Scales; Pyrimidines; Schizophrenia; Schizophrenic Psychology; Treatment Outcome

The effects of paliperidone extended-release on sleep architecture in patients with schizophrenia-related insomnia were evaluated in this multicenter, double-blind, randomized, placebo-controlled study. Patients received paliperidone extended-release 9 mg/day or matching placebo during the 14-day double-blind phase. Sleep architecture and sleep continuity were evaluated using polysomnograms. Subjective sleep measures were evaluated daily using the Leeds Sleep Evaluation Questionnaire. Efficacy and safety were also assessed. Thirty-six patients (17 on paliperidone extended-release, 19 on placebo; mean age 32.2 years) completed the study. Paliperidone extended-release treatment vs. placebo resulted in clinically and statistically significant differences in sleep measurements from baseline to endpoint including a reduction in: persistent sleep latency (41 min), sleep onset latency (35 min), number of awakenings after sleep onset (7), time awake in bed (50 min), and stage 1 sleep duration (12 min); prolongation in: total sleep time (53 min), sleep period time (42 min), stage 2 sleep duration (51 min), and rapid eye movement sleep duration (18 min); and an increase in sleep efficiency index (11%). Paliperidone extended-release, compared with placebo, did not exacerbate daytime somnolence and improved symptoms of schizophrenia. Paliperidone extended-release was well tolerated and improved sleep architecture and sleep continuity in patients diagnosed with schizophrenia and concomitant insomnia.

Topics: Adult; Antipsychotic Agents; Delayed-Action Preparations; Double-Blind Method; Dyskinesia, Drug-Induced; Female; Hospitalization; Humans; Isoxazoles; Male; Middle Aged; Paliperidone Palmitate; Polysomnography; Psychiatric Status Rating Scales; Pyrimidines; Schizophrenia; Schizophrenic Psychology; Sleep Stages; Tablets

An open-label, non-randomized, pilot study has been performed in inpatients in need of treatment with an antipsychotic (risperidone) and an antidepressant (mirtazapine) with the objective to preliminarily assess a possible pharmacokinetic interaction and the tolerability of this combination. A 1-4-week single drug treatment phase (risperidone 1-3 mg bid or mirtazapine 30 mg nocte) was followed by a 2-4-week combined drug treatment phase at unchanged doses. Twelve patients were enrolled, nine of whom were treated with risperidone in the single drug phase. Results of plasma level measurements are available for six patients and indicate that adding mirtazapine to risperidone does not alter steady-state plasma concentrations of risperidone and its 9-hydroxy metabolite. Data from one patient suggest that adding risperidone to mirtazapine does not result in clinically relevant changes in plasma concentrations of either compound. The combination was well tolerated and no major or relevant adverse events were observed. Adding risperidone to mirtazapine probably does not necessitate a change of the dosage of either drug, but more extensive investigations are needed.

Topics: Adult; Aged; Antidepressive Agents, Tricyclic; Antipsychotic Agents; Depression; Depressive Disorder; Drug Interactions; Drug Therapy, Combination; Dyskinesia, Drug-Induced; Dystonia; Female; Humans; Isoxazoles; Male; Mianserin; Middle Aged; Mirtazapine; Paliperidone Palmitate; Pilot Projects; Psychotic Disorders; Pyrimidines; Risperidone; Severity of Illness Index; Treatment Outcome

Topics: Adult; Antipsychotic Agents; Dyskinesia, Drug-Induced; Follow-Up Studies; Humans; Male; Paliperidone Palmitate; Psychotic Disorders; Tardive Dyskinesia; Young Adult

Topics: Adolescent; Antipsychotic Agents; Dyskinesia, Drug-Induced; Dystonia; Humans; Isoxazoles; Male; Paliperidone Palmitate; Pyrimidines; Schizophrenia; Syndrome

Topics: Adult; Antipsychotic Agents; Dyskinesia, Drug-Induced; Female; Humans; Isoxazoles; Paliperidone Palmitate; Psychiatric Status Rating Scales; Psychotic Disorders; Pyrimidines; Time Factors

Topics: Adult; Antipsychotic Agents; Dyskinesia, Drug-Induced; Female; Haloperidol; Humans; Isoxazoles; Paliperidone Palmitate; Palmitates; Schizophrenia

Topics: Adult; Antipsychotic Agents; Benzodiazepines; Drug Substitution; Dyskinesia, Drug-Induced; Humans; Isoxazoles; Male; Olanzapine; Paliperidone Palmitate; Pyrimidines; Schizophrenia; Schizophrenic Psychology; Treatment Outcome

Topics: Antipsychotic Agents; Dyskinesia, Drug-Induced; Humans; Isoxazoles; Male; Middle Aged; Paliperidone Palmitate; Parkinsonian Disorders; Psychotic Disorders; Pyrimidines; Substance Withdrawal Syndrome; Syndrome

Topics: Antipsychotic Agents; Dyskinesia, Drug-Induced; Female; Humans; Isoxazoles; Middle Aged; Paliperidone Palmitate; Pyrimidines; Syndrome

Topics: Antipsychotic Agents; Dyskinesia, Drug-Induced; Female; Humans; Isoxazoles; Paliperidone Palmitate; Pyrimidines; Schizophrenia; Young Adult

This 12-week open-label study was designed to investigate the pharmacokinetics and efficacy of a direct switch from a conventional depot to long-acting injectable risperidone in patients with schizophrenia and schizoaffective disorder.. Men or women from 18 to 65 years old with a diagnosis of schizophrenia or schizoaffective disorder were eligible for participation if they had been treated with conventional depot for at least 8 weeks before study entry. Intramuscular long-acting risperidone was administered starting from 25 mg, with the dose flexibly adjusted every two weeks for 12 weeks from week 4.. Of the 25 patients enrolled in this study, 21 completed at least one post-baseline assessment and were thus included in the analysis. The mean serum concentration of risperidone plus 9-hydroxyrisperidone was 29.1 ng/mL at the 12th week after switching, with an average injection dose of 31.25 mg long-acting risperidone every two weeks. The levels of active moiety of risperidone seemed to be higher in Chinese patients compared to those in Caucasian patients. Positive and Negative Syndrome Scale total scores (from 67.5 to 56.4; P = 0.002), scores for negative symptoms (P = 0.006) and general symptoms (P = 0.001) were improved significantly 12 weeks after the switch. Mean Extrapyramidal Symptom Rating Scale scores were improved significantly from 20.1 to 5.5 (P < 0.001). Significantly decreased levels of cholesterol and triglyceride were found at the 12th week. The levels of fasting glucose, low-density lipoprotein, high-density lipoprotein and bodyweight remained unchanged.. These findings suggest that switching from conventional depot to long-acting risperidone is feasible with the advantage of symptom reduction and side-effect profile decrement.

Topics: Administration, Oral; Adolescent; Adult; Aged; Antipsychotic Agents; Asian People; Delayed-Action Preparations; Dyskinesia, Drug-Induced; Female; Humans; Injections, Intramuscular; Isoxazoles; Male; Middle Aged; Paliperidone Palmitate; Psychiatric Status Rating Scales; Psychotic Disorders; Pyrimidines; Risperidone; Schizophrenia; Treatment Outcome; White People