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

Investigator: Dante Durand

Institutional Protocol #: 20150362

National Clinical Trials Identifier: NCT02431702

Funding Agency/Sponsor: Johnson & Johnson

Division: Psychiatry

Therapeutic Area: Urologic

Phase: Phase III

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 2/9/2016


Purpose/Abstract:


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


Gender: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Accepts healthy volunteers: Accepts Healthy Volunteers

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Nicole Brenson, Manager, Business Operations
(305) 243 3487
nbrenson@miami.edu

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