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A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects With Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics

Trial Profile

A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects With Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Sep 2023

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At a glance

  • Drugs Paliperidone (Primary) ; Aripiprazole; Haloperidol; Olanzapine; Paliperidone; Perphenazine; Quetiapine; Risperidone
  • Indications Psychotic disorders; Schizophrenia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms DREaM
  • Sponsors Janssen

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.
  • 01 May 2023 Results (n=71 DREaM participants (PP, 23; OAP, 48) and n=64 healthy controls) assessing the changes in brain intracortical myelin (ICM) volume in the frontal lobe after 9 months of treatment with paliperidone palmitate (PP) compared with 9 months of treatment with oral antipsychotics (OAP) in participants with recent-onset schizophrenia or schizophreniform disorder from the DREaM study, published in the Schizophrenia Research.
  • 01 Oct 2022 Results of post hoc analysis assessing the time to first major treatment failure (i.e, arrest/incarceration or psychiatric hospitalization) in participants with recent-onset schizophrenia or schizophreniform disorder treated with paliperidone palmitate (PP) versus oral antipsychotics, published in the Schizophrenia Research.

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