A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Disease Progression; Schizophrenia; Mental Disorders; Psychotic Disorders
Intervention: Aripiprazole; Haloperidol; Olanzapine; Oral Paliperidone ER; Perphenazine; Quetiapine; Oral Risperidone; Paliperidone Palmitate Injection (PP1M); Paliperidone Palmitate Injection (PP3M)
Intervention description: Aripiprazole will be administered in accordance with the label or Investigator's discretion; Haloperidol will be administered in accordance with the label or Investigator's discretion; Olanzapine will be administered in accordance with the label or Investigator's discretion; Paliperidone Extended Release (ER) tablets 1.5 to 12 milligram (mg) per day will be administered orally.; Perphenazine will be administered in accordance with the label or Investigator's discretion; Quetiapine will be administered in accordance with the label or Investigator's discretion; Risperidone tablets 1-6 mg per day will be administered orally.; Participants will receive 5 doses of PP1M. First dose at a starting dose of 234 mg on Day 1 and a second dose of 156 mg on Day 8 and then 78 to 234 mg (in 3 flexible doses), every month up to Day 92.; Paliperidone Palmitate injection (PP3M) will be administered once every 12 weeks intramuscularly. The initial dose will be calculated as 3.5 fold multiple of the final PP1M dose administered on Day 92 (or Day 176). Dose will be increased based on Investigator's discretion.
Intervention MeSH terms: Haloperidol; Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate; Haloperidol decanoate; Perphenazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 337.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Paliperidone Palmitate; Oral Antipsychotics; Schizophrenia; Psychotic Disorders; Cognition in Schizophrenia; Brain intracortical myelin volume; Personal and Social Performance; Disease Modification

Summary:

      The purpose of the study is to compare effectiveness of paliperidone palmitate (PP:
      paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP
      [that is oral paliperidone extended release {ER}, oral risperidone, or another OAP]) in
      delaying time to treatment failure. The study will also evaluate changes in cognition,
      functioning, brain intracortical myelin (ICM) volume following treatment with PP compared
      with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have a current diagnosis of schizophrenia (295.90) or
             schizophreniform disorder (295.40) as defined by Diagnostic and Statistical Manual of
             Mental Disorders, 5th edition (DSM-5) and confirmed by the Structured Clinical
             Interview for DSM-5 Disorders (SCID) with a first psychotic episode within the last 24
             months prior to the screening visit

          -  Participant requires treatment with an antipsychotic medication

          -  Participant must sign an informed consent form (ICF) indicating that he or she
             understands the purpose of and procedures required for the study and are willing to
             participate in the study

          -  Participant must have available a designated individual (example, family member,
             significant other, friend) who has knowledge of the participant and is generally aware
             of the participants daily activities, and who agrees to let the study site personnel
             know of changes in the participants circumstances when the participant is not able to
             provide this information. The designated individual must sign an informed consent form

          -  Participant is anticipated to have a stable place of residence for the duration of the
             trial

        Exclusion Criteria:

          -  Participant has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder,
             major depressive disorder, schizoaffective disorder, autistic disorder, or
             intellectual disabilities

          -  Participant meets the DSM-5 definition of moderate or severe substance use disorder
             (except for nicotine) within 2 months prior to Screening

          -  Participant has a history of neuroleptic malignant syndrome

          -  Participant has received long-acting injectable (LAI) medication within 2 injection
             cycles prior to the Screening visit

          -  Participant has mental retardation, defined as pre-morbid intelligence quotient (IQ)
             as measured by Wechsler Test of Adult Reading at Screening less than (<) 70