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Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia

Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia (Recent-onset)

Intervention: paliperidone palmitate (Drug); risperidone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Keith H Nuechterlein, Ph.D., Principal Investigator, Affiliation: University of California, Los Angeles (UCLA) Semel Institute for Neuroscience and Human Behavior

Overall contact:
Kenneth L Subotnik, Ph.D., Phone: (310) 825-0334, Email: ksubotnik@mednet.ucla.edu


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.

Clinical Details

Official title: Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Exacerbation or relapse of psychotic symptoms

Cognitive functioning based on Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery

Role Functioning

Secondary outcome:

Cognitive performance on test battery (MCCB)

Insight (Awareness of Mental Disorder)

Retention in treatment

Social functioning

Emotional reactivity on psychophysiological measures

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 schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer extrapyramidal side effects than older "typical" antipsychotics. Oral risperidone is an atypical antipsychotic medication that is very commonly used to control the symptoms of schizophrenia. Adherence to prescribed oral medication continues to be a major clinical issue. This study will determine the effectiveness of oral risperidone versus a long-acting injectible alternative, paliperidone palmitate, in treating people with first-episode schizophrenia. Impact on clinical symptoms and cognitive functioning will be examined. Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting paliperidone palmitate administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of paliperidone palmitate once every 4 weeks. Dosages will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient oral risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. Study visits will occur once weekly throughout the study. They will include psychiatrist monitoring of medication response and side effects; group therapy meetings focused on everyday living skills; family education about schizophrenia; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms, work recovery, and social functioning.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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.

Locations and Contacts

Kenneth L Subotnik, Ph.D., Phone: (310) 825-0334, Email: ksubotnik@mednet.ucla.edu

UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California 90095, United States; Recruiting
Keith H Nuechterlein, Ph.D., Phone: 310-825-0036, Email: keithn@ucla.edu
Kenneth L Subotnik, Ph.D., Phone: (310) 825-0334, Email: ksubotnik@mednet.ucla.edu
Keith H Nuechterlein, Ph.D., Principal Investigator
Kenneth L Subotnik, Ph.D., Sub-Investigator
Additional Information

UCLA Center for Neurocognition and Emotion in Schizophrenia

Starting date: October 2011
Last updated: June 9, 2013

Page last updated: August 23, 2015

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