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A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual With Oral Antipsychotic Monotherapy in Adults With Schizophrenia

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A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual With Oral Antipsychotic Monotherapy in Adults With Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Sep 2023

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At a glance

  • Drugs Paliperidone (Primary) ; Paliperidone (Primary) ; Aripiprazole; Haloperidol; Olanzapine; Quetiapine; Risperidone
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms PROSIPAL
  • Sponsors Janssen-Cilag

    • Most Recent Events

    • 25 Sep 2023 Results of post hoc pooled analysis of NCT01157351 (PRIDE), NCT01081769 (PROSIPAL), and NCT02431702 (DREaM) assessing the efficacy and safety of paliperidone palmitate (PP) versus oral antipsychotic (OAP) treatment in adult patients diagnosed with schizophrenia (per DSM IV or DSM 5 criteria) and varying duration of illness (o to 3 years and greater than 3 years) published in the Journal of clinical psychiatry, 2023.
    • 21 Jul 2019 This trial has been completed in United Kingdom, according to the European Clinical Trials Database record.
    • 04 Apr 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.

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