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Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330551
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Keith Nuechterlein, Ph.D., University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE May 26, 2006
First Posted Date  ICMJE May 29, 2006
Results First Submitted Date  ICMJE January 2, 2017
Results First Posted Date  ICMJE March 23, 2020
Last Update Posted Date March 23, 2020
Study Start Date  ICMJE March 2006
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2020)
  • Medication Adherence [ Time Frame: Averaged over study participation (up to 12 months) ]
    5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, MEMS cap readings, plasma assays, and psychiatrist judgments for oral risperidone and timing of injections for long-acting injectable risperidone averaged over study participation
  • Exacerbation or Relapse of Psychotic Symptoms [ Time Frame: Occurrence after randomization and until end of study participation (up to 12 mos.) ]
    Dichotomous measure: Presence of any of three psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring any time after randomization and until end of study participation (up to 12 mos.).
  • Return to Work or School (SAS Work Section) [ Time Frame: Measured from Baseline to Month 12 ]
    The Social Adjustment Scale records the return to work or school and the number of weeks in work or school during each 3-month period. For this outcome, outcome as dichotomized as 0 if an individual did not return to work or school and 1 if they did return to competitive work or regular school enrollment.
  • Maintenance of Work/School Attendance (SAS) [ Time Frame: Measured from Baseline to Month 12 ]
    Measured as the number of weeks in which a participant has competitive employment or attends regular school courses. Possible range is 0 to 52 weeks.
  • Global Functioning Scale: Role [ Time Frame: Measured from Baseline to Month 12 ]
    Change on a 10-point scale of work/school functioning. Scale range is from 1 (extreme role dysfunction) to 10 (superior role functioning). Measured by subtracting the baseline rating from the rating at 12 months.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2006)
  • Measured over 12 months: Medication adherence
  • Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)
  • Return to Work or School (SAS Work Section)
  • Maintenance of Work/School Attendance (SAS)
  • Quality of community functioning and interpersonal relatedness (CAF)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2020)
  • MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score [ Time Frame: Measured at baseline and 12 months ]
    The MCCB Overall Composite T score is computed by the MCCB Computer Scoring Program from the raw scores for 10 individual cognitive tests. The mean for the general population of comparable age and sex is 50 with a standard deviation of 10. Higher scores indicate better cognitive functioning. The outcome measure was the change from baseline to 12 months, calculated as 12-month T score minus baseline T score. Higher values indicate better outcome.
  • Emotional Reactivity on Psychophysiological Measures [ Time Frame: Measured from Baseline to Month 12 ]
    Electrodermal reactivity to pictures of negative versus neutral stimuli was the initially proposed measure. Larger skin conductance increases in response to negative pictures compared to neutral pictures would indicate stronger emotional reactivity.
  • Retention in Treatment [ Time Frame: From baseline to 12 months ]
    Number of days on the randomized medication before being switched to a different antipsychotic medication or dropping out of the medication trial. Possible range is 0 to 365, with higher numbers indicating better retention in treatment.
  • Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder-Revised (SUMD-R) [ Time Frame: Baseline to 12 months ]
    Rating scale based on clinician's interview of patient to determine level of lack of awareness of having a mental disorder. Range is from 1 (Aware) to 5 (Unaware), so lower scores indicate better outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2006)
  • Measured over 12 months: Cognitive performance on test battery
  • Emotional Reactivity on Psychophysiological Measures
  • Retention in Treatment
  • Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Official Title  ICMJE Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia
Brief Summary This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone 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 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 adverse side effects than older "typical" antipsychotics. Risperidone is a type of atypical antipsychotic medication that is used to control the symptoms of schizophrenia. This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone 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 risperidone once every 2 weeks. Dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient 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 group therapy meetings focused on everyday living skills; family education about schizophrenia; assessments of medication response; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Oral Risperidone
    Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.
    Other Name: Risperdal
  • Drug: Risperidone in Long-Acting Injectable Form (Consta)
    Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.
    Other Name: Risperdal Consta
Study Arms  ICMJE
  • Experimental: Long-acting injectible risperidone
    Participants who are randomly assigned to this arm will be administered the long-acting injectible form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.
    Intervention: Drug: Risperidone in Long-Acting Injectable Form (Consta)
  • Active Comparator: Oral risperidone
    Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months.
    Intervention: Drug: Oral Risperidone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2020)
126
Original Enrollment  ICMJE
 (submitted: May 26, 2006)
250
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
  • First major episode of psychotic symptoms occurred within 2 years prior to study entry
  • Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia

Exclusion Criteria:

  • Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
  • Mental retardation (e.g., premorbid IQ less than 70)
  • Significant alcohol or substance abuse within 6 months prior to study entry
  • Inability to complete research measures in English
  • Any condition that may make risperidone use medically inadvisable
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00330551
Other Study ID Numbers  ICMJE P50MH066286( U.S. NIH Grant/Contract )
P50MH066286 ( U.S. NIH Grant/Contract )
DATR A2-AISZ ( Registry Identifier: World Health Organization ICTRP )
Janssen RIS-NAP-4009 ( Other Grant/Funding Number: Janssen Scientific Affairs )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Keith Nuechterlein, Ph.D., University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Janssen Scientific Affairs, LLC
Investigators  ICMJE
Principal Investigator: Keith H. Nuechterlein, PhD University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
PRS Account University of California, Los Angeles
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP