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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Behavioral: Group Skills Training and Psychoeducation
Behavioral: Individual Case Management
Drug: Oral Risperidone
Drug: Risperidone in Long-Acting Injectable Form (Consta)
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: Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 135
Study Start Date: March 2006
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Long-acting injectible risperidone
Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management
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: 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
Active Comparator: Oral risperidone
Participants taking daily oral risperidone, plus group skills training and case management
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

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.

  Eligibility

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

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
  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: NCT00330551

Locations
United States, California
Semel Institute for Neuroscience and Human Behavior at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Principal Investigator: Keith H. Nuechterlein, PhD University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
  More Information

Additional Information:
No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keith Nuechterlein, Ph.D., Professor, UCLA, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00330551     History of Changes
Other Study ID Numbers: P50 MH066286, P50MH066286, DATR A2-AISZ, Janssen RIS-NAP-4009
Study First Received: May 26, 2006
Last Updated: November 2, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Schizoaffective Disorder, Depressed Type
Schizophreniform Disorder
First-episode Schizophrenia
Injectable Risperidone

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

ClinicalTrials.gov processed this record on August 26, 2014