- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
Enrollment closed: A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients (clinicaltrials.gov) - Jul 5, 2019 P=N/A, N=3298, Active, not recruiting, Although neither pre-planned nor adequately powered, the estimated HRs suggest that the relative advantage of PP over oral APs for reducing the risk for treatment failure may be greater in patients with recent-onset schizophrenia than in those with more chronic illness. Recruiting --> Active, not recruiting
- |||||||||| Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Enrollment open: Substance Misuse To Psychosis for Stimulants (clinicaltrials.gov) - Jun 12, 2019 P2/3, N=240, Recruiting, Analysis using multivariate linear regression based on generalized estimating equations and sensitivity analysis using a linear mixed model supported the findings. Not yet recruiting --> Recruiting
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Clinical, Journal: Long-Acting Injectable Paliperidone Palmitate: A Review of Efficacy and Safety. (Pubmed Central) - May 31, 2019 Overall, both 1-month and 3-month formulations of PDP are safe and effective in the treatment of schizophrenia and schizoaffective disorder. They may be most effective in patients with prior failed treatment of oral antipsychotics or other LAIAs, in patients with a history of medication noncompliance, or in patients with an individual preference for less frequent dosing.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Journal: Long-acting injection - four-times-a-year. Review of the 3-monthly paliperidone-palmitate injection (Pubmed Central) - May 26, 2019 Data on safety have revealed that TREVICTA was well tolerated and safe, and the rare side effects were consistent with that of paliperidone previously described. In conclusion, TREVICTA is a new and unique treatment option for patients who respond well to paliperidone treatment.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Risperdal Consta (risperidone depot formulation) / J&J
Enrollment open: Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS) (clinicaltrials.gov) - May 2, 2019 P=N/A, N=1000, Recruiting, PP1M was associated with higher antipsychotic adherence and persistence, and similar total costs versus OAA. Not yet recruiting --> Recruiting
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Journal: Is paliperidone palmitate more effective than other long-acting injectable antipsychotics? (Pubmed Central) - Apr 14, 2019 Paliperidone palmitate was more likely to be prescribed in patients with more frequent and lengthy hospital admissions prior to initiation. However, the absence of differences in outcomes after initiation indicates that paliperidone palmitate was not more effective than other cheaper LAI antipsychotics.
- |||||||||| Aristada two-month (aripiprazole lauroxil XR) / Alkermes
Trial completion, Trial completion date, Trial primary completion date: A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia (clinicaltrials.gov) - Apr 12, 2019 P3b, N=200, Completed, However, the absence of differences in outcomes after initiation indicates that paliperidone palmitate was not more effective than other cheaper LAI antipsychotics. Active, not recruiting --> Completed | Trial completion date: Aug 2019 --> Mar 2019 | Trial primary completion date: Aug 2019 --> Mar 2019
- |||||||||| Clinical protocol, Enrollment change: Aripiprazole, Abilify Maintena Collaborative Clinical Protocol (clinicaltrials.gov) - Apr 11, 2019
P4, N=2, Terminated, Active, not recruiting --> Completed | Trial completion date: Aug 2019 --> Mar 2019 | Trial primary completion date: Aug 2019 --> Mar 2019 N=19 --> 2
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Clinical, Journal: Early Australian experience in the maintenance of schizophrenia management with 3-monthly paliperidone palmitate. (Pubmed Central) - Apr 11, 2019 Convenient 3-monthly dosing was preferred by clinicians and patients, and symptoms were adequately managed. This has the potential to improve adherence and lead to better outcomes as patients only need four intramuscular doses per year.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Clinical, Journal: Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation. (Pubmed Central) - Apr 10, 2019 P3 At double-blind baseline, a 1-point reduction in Marder negative symptom factor score was associated with a 20% increase in the odds of achieving remission after PP3M treatment; 1-point reduction in CGI-S was associated with a doubling in remission odds; and 7- and 10-point improvements in PSP scores, respectively, were associated with 42% and 65% increases in remission odds. Patients with early clinically meaningful improvements in disease symptoms and severity while establishing stable PP1M dosage are more likely to achieve remission after transition to PP3M.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Hafyera (paliperidone palmitate extended-release 6-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Enrollment closed: A Study of Paliperidone Palmitate 6-Month Formulation (clinicaltrials.gov) - Apr 8, 2019 P3, N=840, Active, not recruiting, Patients with early clinically meaningful improvements in disease symptoms and severity while establishing stable PP1M dosage are more likely to achieve remission after transition to PP3M. Recruiting --> Active, not recruiting
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Journal: Paliperidone palmitate three-month depot formulation: a helpful innovation with practical pitfalls. (Pubmed Central) - Apr 7, 2019 There are significant challenges: ensuring timely administration and switching a three-month depot treatment to another antipsychotic may be problematic. Paliperidone palmitate three-month depot injection represents an advance for both convenience and effectiveness in the long term psychopharmacological treatment of schizophrenia.
- |||||||||| Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
Level of Compliance With Long Acting Injections and Risk of Hospitalization (Regency S-V) - Apr 3, 2019 - Abstract #SIRS2019SIRS_137; This group demonstrated the best outcomes in terms of reduced hospitalizations with more than half of the patients having no admission during 3 years follow up. Patients with poor compliance had the worst outcomes: they were twice as likely to have completely discontinued PP1M at 3 years as well as showing the highest hospitalization rates both before and after PPM1 initiation.
- |||||||||| Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes
Ongoing Randomized, Double-Blind, Active-Controlled Study of Starting Aripiprazole Lauroxil With a 1-Day Initiation Regimen in Acutely Ill Patients With Schizophrenia: Rationale, Study Design, and Patient Population at Baseline (Regency S-V) - Apr 3, 2019 - Abstract #SIRS2019SIRS_48; P3b On day 1, patients randomized to AL receive a blinded intramuscular (IM) injection of Aristada Initio (675 mg), along with a blinded, single, 30 mg oral dose of aripiprazole...The mean (SD) baseline PANSS score was 94.5 (8.8), which is consistent with acute schizophrenia. Discussion This study will provide important efficacy and safety information related to initiation and continuation of two LAI options available for hospital treatment of acute symptoms of schizophrenia.
- |||||||||| Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Trial initiation date: Substance Misuse To Psychosis for Stimulants (clinicaltrials.gov) - Feb 15, 2019 P2/3, N=240, Not yet recruiting, Limits of this study are mainly related with the duration of the clinical trial and to assumptions on the transposability of measured consumed resources in the international clinical trial to the French healthcare system. Initiation date: Dec 2018 --> Apr 2019
- |||||||||| Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J
Enrollment closed: EULAST: European Long-acting Antipsychotics in Schizophrenia Trial (clinicaltrials.gov) - Jan 16, 2019 P4, N=536, Active, not recruiting, Initiation date: Dec 2018 --> Apr 2019 Recruiting --> Active, not recruiting
- |||||||||| Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
Trial completion date, Trial initiation date, Trial primary completion date: Substance Misuse To Psychosis for Stimulants (clinicaltrials.gov) - Sep 4, 2018 P2/3, N=240, Not yet recruiting, Recruiting --> Active, not recruiting Trial completion date: Dec 2021 --> Mar 2022 | Initiation date: Aug 2018 --> Dec 2018 | Trial primary completion date: Sep 2021 --> Dec 2021
- |||||||||| Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck, Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J, Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J
New P2/3 trial: Substance Misuse To Psychosis for Stimulants (clinicaltrials.gov) - Apr 2, 2018 P2/3, N=240, Not yet recruiting,
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