Status:
COMPLETED
Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Janssen Scientific Affairs, LLC
Conditions:
Schizophrenia (Recent-onset)
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode...
Eligibility Criteria
Inclusion
- A first episode of a psychotic illness is occurring or did occur within the last 2 years;
- A diagnosis by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition(DSM-IV)of schizophrenia, schizoaffective disorder, depressed type, or schizophreniform disorder; and
- Between 18 and 45 years of age.
Exclusion
- Neurological disorder (e.g., epilepsy) or significant head injury;
- 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;
- Mental retardation, i.e. premorbid intelligence quotient (IQ) less than 70;
- Insufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal abilities;
- Residence likely to be outside of commuting distance of the University of California, Los Angeles (UCLA) Aftercare Research Program; or
- Patient has shown an inadequate response to an adequate previous trial of oral or long-acting injectable risperidone, paliperidone, or paliperidone palmitate.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01451736
Start Date
October 1 2011
End Date
December 31 2021
Last Update
April 11 2022
Active Locations (1)
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1
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States, 90095