Summary

for people ages 18-35 (full criteria)
healthy people welcome
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

A Prospective, matched-control, Randomized (assignment of study drug by chance), open-label, flexible-dose, study in participants with recent-onset schizophrenia or schizophreniform disorder to compare disease progression and disease modification following treatment with PP long-acting injection (once-monthly followed by 3-month injections) or OAP (Any of the following 7 OAPs are permitted: aripiprazole, haloperidol, olanzapine, paliperidone ER, perphenazine, quetiapine, and risperidone). The study consists of 3 parts. Part-1 (Oral Run-In Phase), Part-2 (Disease Progression) and Part-3 (Extended Disease Progression and Disease Modification) with unique endpoints. Screening period will be up to 4 Weeks. Duration of Parts will be as: 2 months for Part-1, 9 months for Part-2 and Part-3. All participants will initially receive oral paliperidone ER or oral risperidone in Part-1. After paliperidone/risperidone treatment in Part-1, participants will be randomized into 1:2 ratio to receive PP or OAP in Part-2. Participants who complete Part-2 will enter into Part-3 wherein OAP group participants of Part-2 will be re-randomized into 1:1 ratio to OAP-OAP group and OAP-PP group, and PP group will continue without further randomization. Treatment failures will be evaluated in Part-2 and Part-3 of the study. Also changes in cognition, functioning, brain intracortical myelin (ICM) volume will be evaluated in the study. Participants' safety will be monitored throughout.

Keywords

Schizophrenia Psychotic Disorders Paliperidone Palmitate Oral Antipsychotics Cognition in Schizophrenia Brain intracortical myelin volume Personal and Social Performance Disease Modification Mental Disorders Disease Progression Risperidone Antipsychotic Agents Aripiprazole Olanzapine Quetiapine Fumarate Haloperidol Haloperidol decanoate Perphenazine Oral Paliperidone ER Quetiapine Oral Risperidone Paliperidone Palmitate Injection (PP1M) Paliperidone Palmitate Injection (PP3M)

Eligibility

You can join if…

Open to people ages 18-35

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego/Psychiatry accepting new patients
    San Diego California 92103 United States
  • Synergy East accepting new patients
    Lemon Grove California 91945 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Scientific Affairs, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT02431702
Phase
Phase 3
Study Type
Interventional
Last Updated
May 30, 2018