The Comparative Effects of Risperidone Long-Acting Injection and Paliperidone Palmitate on Social Functioning in Schizophrenia: A 6-Month, Open-Label, Randomized Controlled Pilot Trial

2016 ◽  
Vol 73 (1) ◽  
pp. 35-42 ◽  
Author(s):  
Yosuke Koshikawa ◽  
Yoshiteru Takekita ◽  
Masaki Kato ◽  
Shiho Sakai ◽  
Ai Onohara ◽  
...  
Keyword(s):  
Social Functioning ◽  
Pilot Trial ◽  
Paliperidone Palmitate ◽  
Open Label ◽  
Randomized Controlled ◽  
Long Acting

scholarly journals Cognitive function and risperidone long-acting injection vs. paliperidone palmitate in schizophrenia: a 6-month, open-label, randomized, pilot trial

2016 ◽  
Vol 16 (1) ◽  
Author(s):  
Yoshiteru Takekita ◽  
Yosuke Koshikawa ◽  
Chiara Fabbri ◽  
Shiho Sakai ◽  
Naotaka Sunada ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Pilot Trial ◽  
Paliperidone Palmitate ◽  
Open Label ◽  
Long Acting

scholarly journals Impact of paliperidone palmitate one-month formulation on relapse prevention in patients with schizophrenia: A post-hoc analysis of a one-year, open-label study stratified by medication adherence

2018 ◽  
Vol 32 (6) ◽  
pp. 691-701 ◽  
Author(s):  
Tianmei Si ◽  
Nan Li ◽  
Huafei Lu ◽  
Shangli Cai ◽  
Jianmin Zhuo ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Hazard Ratio ◽  
Paliperidone Palmitate ◽  
Open Label ◽  
First Relapse ◽  
Continued Use ◽  
One Year ◽  
Long Acting ◽  
Post Hoc

Background: Limited data are available to help identify patients with schizophrenia who are most likely to benefit from long-acting injectable antipsychotics. Aim: To investigate the efficacy of long-acting injectable antipsychotic paliperidone palmitate one-month formulation for preventing relapses, factors influencing time to first relapse, and the effect of different antipsychotic adherence levels on time to first relapse in Chinese patients with schizophrenia. Methods: This was a post-hoc analysis from an open-label, single-arm study of stable patients (Positive and Negative Syndrome Scale total score <70; n=367) receiving paliperidone palmitate one-month formulation at the end of an acute 13-week treatment phase, who entered a naturalistic one-year follow-up period, either continuing with flexibly dosed paliperidone palmitate one-month formulation (75–150 mg eq.) or switching to another antipsychotic(s). Results: There were 362/367 patients (age=31.4±10.75 years) included in the analysis of time to first relapse (primary outcome) and 327/362 patients (39/327, poor antipsychotic adherence (<80%)) willing to receive antipsychotics were included in the exposure/adherence analysis. Overall, 84.6% (95% confidence interval=79.2–88.7) patients remained relapse-free. Poor adherence during follow-up (hazard ratio=2.97, 95% confidence interval=1.48–5.98, p=0.002) and frequent hospitalizations in the previous year (hazard ratio=1.29, 95% confidence interval=1.02–1.62, p=0.03) were associated with a significant risk of shorter time to first relapse in the univariate analysis. In patients with poor adherence, ‘no use’ (hazard ratio=13.13, 95% confidence interval=1.33–129.96, p=0.03) and ‘interrupted use’ (hazard ratio=11.04, 95% confidence interval=1.03–118.60, p=0.047) of paliperidone palmitate one-month formulation (vs continued use) showed a significantly higher risk of relapse; this was not observed in patients with good (≥80%) antipsychotic adherence. No new safety concerns were identified. Conclusion: Continued use of paliperidone palmitate one-month formulation/long-acting injectable antipsychotic was effective in preventing schizophrenia relapses, especially in patients with suboptimal antipsychotic adherence.

scholarly journals Symptomatic and functional outcomes after treatment with paliperidone palmitate 3-month formulation for 52 weeks in patients with clinically stable schizophrenia

2020 ◽  
Vol 10 ◽  
pp. 204512532092634 ◽  
Author(s):  
Maria Paz Garcia-Portilla ◽  
Pierre-Michel Llorca ◽  
Giuseppe Maina ◽  
Vasilis P. Bozikas ◽  
Halise Devrimci-Ozguven ◽  
...  
Keyword(s):  
Treatment Period ◽  
Maintenance Treatment ◽  
Randomized Clinical Trials ◽  
Social Performance ◽  
Paliperidone Palmitate ◽  
Antipsychotic Treatment ◽  
Open Label ◽  
Open Label Phase ◽  
Symptomatic Remission ◽  
Long Acting

Background: Paliperidone palmitate 3-monthly (PP3M) formulation is a long-acting, injectable antipsychotic treatment approved in many countries worldwide for the maintenance treatment of adult patients with schizophrenia. This single-arm, open-label, phase IIIb study evaluated the efficacy and safety of converting patients with schizophrenia stabilized with paliperidone palmitate 1-month (PP1M) to PP3M in a naturalistic clinical setting. Methods: After screening (days –7 to 1), patients were converted from PP1M (50–150 mg eq.) to PP3M (175–525 mg eq.), and entered a 52-week, flexible-dose PP3M treatment period. The primary efficacy endpoint was symptomatic remission (SR) (Andreasen criteria) at last observation carried forward (LOCF) endpoint. Results: Patients ( n = 305) received PP3M, of whom 291 (95.4%) completed the study. Doses of PP3M remained stable during the 12-month treatment period, and changes in dose were uncommon. Overall, 56.8% of patients [95% confidence interval (CI): 51.0, 62.4] achieved SR, and 31.8% achieved both symptomatic and functional remission (Personal and Social Performance scale total score > 70) at LOCF endpoint. Secondary endpoint results were generally consistent with primary endpoint results. There were improvements in Positive and Negative Syndrome Scale total, subscale and Marder factor scores, and also Clinical Global Impression-Severity and -Change scores from baseline to LOCF endpoint. Carer burden was reduced, and the proportion of patients requiring hospitalization for psychiatric reasons decreased from 13.5% in the 12 months prior to baseline to 4.6% during the treatment period. No new safety signals were identified. Conclusion: Results from this naturalistic study were similar to those observed in previous randomized clinical trials of PP3M and underline the importance of continuous maintenance treatment in patients with schizophrenia.

Effect of Two Long-acting Treatments, The Paliperidone Palmitate 1-month and 3-month Formulations on Caregiver Burden in European patients with Schizophrenia

2017 ◽  
Vol 41 (S1) ◽  
pp. S198-S198
Author(s):  
L. Hargarter ◽  
S. Gopal ◽  
H. Xu ◽  
K. McQuarrie ◽  
A. Savitz ◽  
...  
Keyword(s):  
Caregiver Burden ◽  
Paliperidone Palmitate ◽  
Open Label ◽  
Double Blind ◽  
Psychiatric Hospitalizations ◽  
Sum Score ◽  
Prior Use ◽  
Significant Burden ◽  
Oral Antipsychotic ◽  
Long Acting

IntroductionSchizophrenia puts a significant burden on caregivers.ObjectivesTo explore the effects of two long-acting treatments (LAT), paliperidone palmitate 1-month and 3-month formulations on caregiver burden (CGB) in European patients with schizophrenia using the Involvement Evaluation Questionnaire (IEQ)AimsTo conduct a subgroup analysis of two randomized, double-blind studies (NCT01515423 and NCT01529515).MethodsCaregivers (≥ 1 h of contact/week with the patients) were offered to complete the IEQ (31 items, each scoring: 0–4; total score: sum of 27 items [0–108]).ResultsAmong 756 European caregivers (53% parents, 18% spouse/partner or girl/boyfriend, 10% sister/brother), 60% reported a CGB of ≥ 32 hours/week at open-label baseline (BL-OL). CGB reduced significantly for patients with both BL-OL and at least one double-blind IEQ sum-score (n = 433): mean improvement [SD] (9.9 [12.66], P < 0.001) from BL-OL (mean [SD] 26.0 [13.30]) to study end (16.0 [10.47]); (reduction in burden associated with worrying [2.9 points] and urging [4.3 points]). CGB significantly improved in patients on prior oral antipsychotics post-switching to LAT with less leisure days impacted and less hours spent in caregiving (P < 0.001). There was significant relationship between improvements and relapse status, patient age (P < 0.001), age at diagnosis (P < 0.002), and number of prior psychiatric hospitalizations in the last 24 months (P < 0.05). Prior use of long-acting antipsychotics other than paliperidone palmitate 1-month or 3-month formulations at BL-OL and duration of prior psychiatric hospitalizations in the last 24 months did not show significant effect on improvements.ConclusionSwitching from an oral antipsychotic to an LAT can provide a meaningful and significant improvement in caregiver burden.Disclosure of interestAll authors are employees of Janssen Research & Development, LLC and hold stocks in the company.

scholarly journals Effects and Feasibility of Hyperthermic Baths for Patients with Depressive Disorder: A Randomized Controlled Clinical Pilot Trial

2018 ◽  
Author(s):  
Johannes Naumann ◽  
Catharina Sadaghiani ◽  
Iris Kruza ◽  
Luisa Denkel ◽  
Gunver Kienle ◽  
...  
Keyword(s):  
Depressive Disorder ◽  
Doctoral Students ◽  
Rating Scale ◽  
Water Immersion ◽  
Pilot Trial ◽  
Severe Depression ◽  
Moderate Intensity ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled

AbstractBackgroundEvaluation of efficacy, safety and feasibility of hyperthermic baths (HTB; head-out-of-water-immersion in 40°C), twice a week, compared to a physical exercise program (PEP; moderate intensity aerobic exercises) in moderate to severe depression.MethodSingle-site, open-label randomized controlled 8-week parallel-group pilot study at an university outpatient clinic as part of usual depression care. Medically stable outpatients with depressive disorder (ICD-10: F32/F33) as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥18 and a score ≥2 on item 1 (Depressed Mood) were randomly assigned to receive either two sessions of HTB or PEP per week (40-45 min) provided by two trained doctoral students. An independent biometric center used computer-generated tables to allocate treatments. Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) principle.Findings45 patients (HTB n = 22; PEP n = 23) were randomized and analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference was 4.3 points in the HAM-D score in favor of HTB (p<0.001). This improvement was achieved after two weeks. Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was far higher than in other trials investigating exercise in depression (18.1 % dropouts).ConclusionsHTB seems to be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depressive disorder after two weeks; it is also suitable for persons who have problems performing exercise training.Trial registrationGerman Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study.

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