Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Keith Nuechterlein, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00330551
First received: May 26, 2006
Last updated: November 2, 2013
Last verified: November 2013

May 26, 2006
November 2, 2013
March 2006
November 2012   (final data collection date for primary outcome measure)
  • Medication adherence [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Return to work or school (SAS Work Section) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Maintenance of work/school attendance (SAS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Quality of community functioning and interpersonal relatedness (CAF) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • 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)
Complete list of historical versions of study NCT00330551 on ClinicalTrials.gov Archive Site
  • Cognitive performance on test battery [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Emotional reactivity on psychophysiological measures [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Retention in treatment [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • 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)
Not Provided
Not Provided
 
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia

This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
  • Behavioral: Group Skills Training and Psychoeducation
    Group skills training sessions will be weekly throughout the study. The sessions 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.
  • Behavioral: Individual Case Management
    An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.
  • Drug: Oral Risperidone
    Daily oral risperidone dosage will 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 once every 2 weeks. Dosage will be adjusted if needed.
    Other Name: Risperdal Consta
  • Experimental: Long-acting injectible risperidone
    Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management
    Interventions:
    • Behavioral: Group Skills Training and Psychoeducation
    • Behavioral: Individual Case Management
    • Drug: Risperidone in Long-Acting Injectable Form (Consta)
  • Active Comparator: Oral risperidone
    Participants taking daily oral risperidone, plus group skills training and case management
    Interventions:
    • Behavioral: Group Skills Training and Psychoeducation
    • Behavioral: Individual Case Management
    • Drug: Oral Risperidone
Bartzokis G, Lu PH, Amar CP, Raven EP, Detore NR, Altshuler LL, Mintz J, Ventura J, Casaus LR, Luo JS, Subotnik KL, Nuechterlein KH. Long acting injection versus oral risperidone in first-episode schizophrenia: differential impact on white matter myelination trajectory. Schizophr Res. 2011 Oct;132(1):35-41. Epub 2011 Jul 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00330551
P50 MH066286, P50MH066286, DATR A2-AISZ, Janssen RIS-NAP-4009
Not Provided
Keith Nuechterlein, Ph.D., University of California, Los Angeles
University of California, Los Angeles
  • National Institute of Mental Health (NIMH)
  • Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: Keith H. Nuechterlein, PhD University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
University of California, Los Angeles
November 2013

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