Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of California, Los Angeles
Sponsor:
Collaborators:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Keith Nuechterlein, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01451736
First received: October 11, 2011
Last updated: June 9, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Schizophrenia (Recent-onset)
Drug: paliperidone palmitate
Drug: risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Exacerbation or relapse of psychotic symptoms [ Time Frame: Evaluated for 12 months ] [ Designated as safety issue: No ]
    Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)

  • Cognitive functioning based on Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    The Overall Composite Score from the MATRICS Consensus Cognitive Battery will be the primary cognitive outcome measure.

  • Role Functioning [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    Role Functioning Scale (RFS; Goodman et al. 1993).


Secondary Outcome Measures:
  • Cognitive performance on test battery (MCCB) [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]
    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.

  • Insight (Awareness of Mental Disorder) [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]
    Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)

  • Retention in treatment [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
    Retention in treatment

  • Social functioning [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    Social Functioning Scale (Goodman et al., 1993)

  • Emotional reactivity on psychophysiological measures [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]
    Emotional reactivity on psychophysiological measures


Estimated Enrollment: 170
Study Start Date: October 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Invega Sustenna
Active Comparator: oral risperidone
Participants will be provided oral risperidone, plus group skills training and case management
Drug: risperidone
oral
Other Name: Risperdal

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451736

Contacts
Contact: Kenneth L Subotnik, Ph.D. (310) 825-0334 ksubotnik@mednet.ucla.edu
Contact: Luana Turner, Psy.D. (310) 794-7340 luana@ucla.edu

Locations
United States, California
UCLA Semel Institute for Neuroscience and Human Behavior Recruiting
Los Angeles, California, United States, 90095
Contact: Keith H Nuechterlein, Ph.D.    310-825-0036    keithn@ucla.edu   
Contact: Kenneth L Subotnik, Ph.D.    (310) 825-0334    ksubotnik@mednet.ucla.edu   
Principal Investigator: Keith H Nuechterlein, Ph.D.         
Sub-Investigator: Kenneth L Subotnik, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
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
  More Information

Additional Information:
No publications provided

Responsible Party: Keith Nuechterlein, Ph.D., Professor, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01451736     History of Changes
Other Study ID Numbers: P50 MH066286 Phase II, P50MH066286, R092670SCH4005
Study First Received: October 11, 2011
Last Updated: June 9, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
First-episode Schizophrenia
Schizoaffective Disorder, Depressed Type (recent-onset)
Schizophreniform Disorder
oral risperidone
long-acting injectable paliperidone palmitate
functional outcome

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014