scholarly journals Paliperidone Palmitate Every Three Months (PP3M) 2-Year Treatment Compliance, Effectiveness and Satisfaction Compared with Paliperidone Palmitate-Monthly (PP1M) in People with Severe Schizophrenia

2021 ◽  
Vol 10 (7) ◽  
pp. 1408
Author(s):  
Juan J. Fernández-Miranda ◽  
Silvia Díaz-Fernández ◽  
Domenico De Berardis ◽  
Francisco López-Muñoz
Keyword(s):  
Adverse Effects ◽  
Treatment Satisfaction ◽  
Hospital Admissions ◽  
Treatment Compliance ◽  
Paliperidone Palmitate ◽  
Open Label ◽  
Open Label Study ◽  
Clinical Global Impression Severity ◽  
High Doses ◽  
Clinical Stabilization

Paliperidone palmitate every three months (PP3M) is expected to facilitate patient’s treatment compliance and satisfaction. The objective here was to compare PP3M treatment compliance and satisfaction, effectiveness and tolerability, with paliperidone palmitate-monthly (PP1M) in patients with severe schizophrenia. A 24-month prospective, open-label study of patients with severe schizophrenia treated with PP3M after at least 2 years of stabilization with PP1M (n = 84) was carried out. Treatment satisfaction was assessed with the Treatment Satisfaction Questionnaire for Medication (TSQM) and with a Visual Analogue Scale (VAS). Effectiveness was measured with psychiatric hospital admissions and the Clinical Global Impression-Severity (CGI-S) scale. Tolerability assessments included laboratory tests, weight and adverse effects. Reasons for treatment discontinuation were recorded. CGI-S significantly improved after 24 months. Three patients changed back to PP1M due to adverse effects, and four were hospitalized. There were neither abandoning nor significant changes in weight or biological parameters, and lower incidence of side effects, with PP3M treatment. TSQM and VAS scales increased. No differences were found related to doses. Apart from somewhat improvement in treatment adherence, effectiveness, and tolerability, patients with severe schizophrenia lengthy treated with PP1M showed more satisfaction with PP3M, even those who needed high doses to get clinical stabilization.

A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia

2010 ◽  
Vol 25 (5) ◽  
pp. 685-697 ◽  
Author(s):  
S Gopal ◽  
U Vijapurkar ◽  
P Lim ◽  
M Morozova ◽  
M Eerdekens ◽  
...  
Keyword(s):  
Paliperidone Palmitate ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Switching patients with schizophrenia from paliperidone palmitate to aripiprazole lauroxil: A 6-month, prospective, open-label study

2019 ◽  
Vol 208 ◽  
pp. 44-48
Author(s):  
Brian J. Miller ◽  
Amy Claxton ◽  
Yangchun Du ◽  
Peter J. Weiden ◽  
Steven G. Potkin
Keyword(s):  
Paliperidone Palmitate ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Paliperidone in the treatment of delirium: results of a prospective open-label pilot trial

2011 ◽  
Vol 23 (4) ◽  
pp. 179-183 ◽  
Author(s):  
Ho-Kyoung Yoon ◽  
Yong-Ku Kim ◽  
Changsu Han ◽  
Young-Hoon Ko ◽  
Heon-Jeong Lee ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Rating Scale ◽  
Small Sample Size ◽  
Pilot Trial ◽  
Small Sample ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Before And After ◽  
The Status

Yoon H-K, Kim Y-K, Han C, Ko Y-H, Lee H-J, Kwon D-Y, Kim L. Paliperidone in the treatment of delirium: results of a prospective open-label pilot trial.Objective: Delirium is a life-threatening neuropsychiatric syndrome characterised by disturbances in consciousness, attention, cognition and perception. Antipsychotics are considered the drugs of choice in managing the symptoms of delirium. Paliperidone is a benzisoxazole derivative and the principal active metabolite of risperidone. In this study, we aimed to evaluate the efficacy of paliperidone for the treatment of delirium.Methods: A prospective open-label study of paliperidone for delirium treatment was performed with 6-day follow-up. Fifteen patients who met Diagnostic and Statistical Manual of Mental disorders, Fourth Edition criteria for delirium and had a score of 13 on the Delirium Rating Scale were recruited. The starting dose was 3 mg once a day and the dose was adjusted depending on the status of delirium. Daily assessments of the severity of delirium were evaluated using Memorial Delirium Assessment Scale (MDAS).Results: The mean daily maintenance dose of paliperidone was 3.75 ± 1.06. The MDAS scores before and after treatment (day 7) were 23.60 ± 6.31 and 11.33 ± 5.45 (t = 6.78, p < 0.001), respectively. The intensity of delirium showed a statistically significant reduction in MDAS scores from the first day of treatment. No serious adverse effects were observed, and none of the patients discontinued paliperidone because of adverse effects.Conclusions: This study shows that low-dose paliperidone is effective in reducing behavioural disturbances and symptoms in delirium and is well tolerated in delirious patients. This trial is an open-label study with a small sample size, and further controlled studies will be necessary.

scholarly journals Pharmacologic doses of recombinant human erythropoietin in the treatment of myelodysplastic syndromes [see comments]

Blood ◽  
1991 ◽  
Vol 78 (7) ◽  
pp. 1658-1663 ◽  
Author(s):  
RS Stein ◽  
RI Abels ◽  
SB Krantz
Keyword(s):  
Myelodysplastic Syndromes ◽  
Recombinant Human Erythropoietin ◽  
Refractory Anemia ◽  
Double Blind Trial ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Human Erythropoietin ◽  
High Doses

Abstract Twenty patients with myelodysplastic syndromes (MDS) entered a randomized, placebo-controlled, double-blind trial designed to evaluate the efficacy and toxicity of high doses of recombinant human erythropoietin (rhEPO). Patients completing the trial were eligible to receive rhEPO as part of an open-label study. Eighteen patients were transfusion dependent; 10 had refractory anemia (RA), and 10 had refractory anemia with ringed sideroblasts (RARS). A response to rhEPO was defined as an increase in hematocrit of 4 percentage points or more over baseline, or the elimination of all transfusions with the hematocrit stable at the baseline level. In the double-blind trial, 1 patient (12.5%) receiving rhEPO responded, as compared with no responses in the placebo group. Overall, responses occurred in 4 of 17 patients (24%) receiving rhEPO at a dose of 1,200 to 1,600 U/kg intravenously (IV) twice weekly. Changes in granulocyte or platelet counts were not observed. Despite the administration of high doses of rhEPO, toxicity attributable to rhEPO was not observed in either the double-blind or open-label study. Response to rhEPO was not significantly related to age, gender, type of MDS, time since diagnosis, time since initiation of transfusion therapy, or baseline serum EPO. These studies indicate that rhEPO can be administered safely in very high doses to patients with MDS and that 24% of these patients will respond with increased erythropoiesis.

Pilot Open-Label Study of Alprazolam (U-31,889) in Anxious Alcoholic Out-Patients

1977 ◽  
Vol 5 (1) ◽  
pp. 26-32 ◽  
Author(s):  
Louis F Fabre ◽  
Allison Gainey ◽  
Sherrie Kemple
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Therapeutic Effect ◽  
Analysis Of Variance ◽  
Marked Improvement ◽  
Study Analysis ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Twenty out-patients suffering from anxiety and tension after withdrawal from alcohol were treated for 28 days with alprazolam. Three patients dropped out for intercurrent events, and 2 dropped out for recurrent drinking. Of the 15 patients completing the study, analysis of variance showed significant improvement in all Physician's Ratings as well as all patient self-ratings. At the 28th day, 93% of the patients rated moderate to marked improvement on the Physician's Global Impression and Therapeutic Effect, and 93% self rated at least a little better. Side-effects were generally mild and inconsequential. No adverse effects attributable to alprazolam were noted on laboratory evaluations, EKG's, or ophthalmologic examinations.

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