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

• Status: Completed
• Trial end date: 2019-11-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Treatments: Antipsychotic Agents; Aripiprazole; Haloperidol; Haloperidol decanoate; Olanzapine; Paliperidone Palmitate; Perphenazine; Polystyrene sulfonic acid; Quetiapine Fumarate; Risperidone

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