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

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT01451736
Collaborator
National Institute of Mental Health (NIMH) (NIH), Janssen Scientific Affairs, LLC (Industry)
146
1
2
123
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: paliperidone palmitate
long-acting injectable
Other Names:
  • Invega Sustenna
  • Active Comparator: oral risperidone

    Participants will be provided oral risperidone, plus group skills training and case management

    Drug: risperidone
    oral
    Other Names:
  • Risperdal
  • Outcome Measures

    Primary Outcome Measures

    1. Exacerbation or relapse of psychotic symptoms [Evaluated for 12 months]

      Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)

    2. Cognitive functioning based on Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery [Baseline to 12 months]

      The Overall Composite Score from the MATRICS Consensus Cognitive Battery will be the primary cognitive outcome measure.

    3. Role Functioning [Baseline to 12 months]

      Role Functioning Scale (RFS; Goodman et al. 1993).

    Secondary Outcome Measures

    1. Cognitive performance on test battery (MCCB) [Measured at baseline and 12 months]

      The cognitive domain scores from the MATRICS Consensus Cognitive Battery (MCCB) will be used as secondary measures to identify the domains in which treatment effects occurred.

    2. Insight (Awareness of Mental Disorder) [Measured at baseline and 12 months]

      Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)

    3. Retention in treatment [Measured at 12 months]

      Retention in treatment

    4. Social functioning [Baseline to 12 months]

      Social Functioning Scale (Goodman et al., 1993)

    5. Emotional reactivity on psychophysiological measures [Measured at baseline and 12 months]

      Emotional reactivity on psychophysiological measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Semel Institute for Neuroscience and Human Behavior Los Angeles California United States 90095

    Sponsors and Collaborators

    • University of California, Los Angeles
    • National Institute of Mental Health (NIMH)
    • Janssen Scientific Affairs, LLC

    Investigators

    • Principal Investigator: Keith H Nuechterlein, Ph.D., University of California, Los Angeles (UCLA) Semel Institute for Neuroscience and Human Behavior

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Keith Nuechterlein, Ph.D., Professor, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT01451736
    Other Study ID Numbers:
    • P50 MH066286 Phase II
    • P50MH066286
    • R092670SCH4005
    • NCT01458379
    First Posted:
    Oct 14, 2011
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Keith Nuechterlein, Ph.D., Professor, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2022