Schizophrenia (Recent-onset) | Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia
Schizophrenia (Recent-onset) research study
What is the primary objective of this study?
This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode schizophrenia.
Who is eligible to participate?
Inclusion Criteria: 1. A first episode of a psychotic illness is occurring or did occur within the last 2 years; 2. A diagnosis by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition(DSM-IV)of schizophrenia, schizoaffective disorder, depressed type, or schizophreniform disorder; and 3. Between 18 and 45 years of age. Exclusion Criteria: 1. Neurological disorder (e.g., epilepsy) or significant head injury; 2. Significant alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous; 3. Mental retardation, i.e. premorbid intelligence quotient (IQ) less than 70; 4. Insufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal abilities; 5. Residence likely to be outside of commuting distance of the University of California, Los Angeles (UCLA) Aftercare Research Program; or 6. Patient has shown an inadequate response to an adequate previous trial of oral or long-acting injectable risperidone, paliperidone, or paliperidone palmitate.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:paliperidone palmitatelong-acting injectable
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
paliperidone palmitate (Invega Sustenna)Participants will be provided paliperidone palmitate (Invega Sustenna), administered in injectible long-acting form, plus group skills training and case management
oral risperidoneParticipants will be provided oral risperidone, plus group skills training and case management
Start Date: October 2011
Completed Date: December 2017
Phase: Phase 4
Primary Outcome: Exacerbation or relapse of psychotic symptoms
Secondary Outcome: Cognitive performance on test battery (MCCB)
Study sponsors, principal investigator, and references
Principal Investigator: Keith H Nuechterlein, Ph.D.
Lead Sponsor: University of California, Los Angeles
Collaborator: National Institute of Mental Health (NIMH)