Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Janssen Scientific Affairs, LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: Aripiprazole
  • Drug: Haloperidol
  • Drug: Olanzapine
  • Drug: Oral Paliperidone ER
  • Drug: Perphenazine
  • Drug: Quetiapine
  • Drug: Oral Risperidone
  • Drug: Paliperidone Palmitate Injection (PP1M)
  • Drug: Paliperidone Palmitate Injection (PP3M)

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - 35 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting