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Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Keith Nuechterlein, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00333177
First received: June 1, 2006
Last updated: March 27, 2013
Last verified: March 2013

June 1, 2006
March 27, 2013
March 2006
January 2013   (final data collection date for primary outcome measure)
  • Cognitive performance on test battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery plus additional measures) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Work or school functioning (Global Functioning Scale: Role) [ Time Frame: Measured every 3 months for 1 year ] [ Designated as safety issue: No ]
  • Maintenance of work/school attendance (SAS) [ Time Frame: Measured every 3 months for 1 year ] [ Designated as safety issue: No ]
  • Quality of work or school functioning, as assessed by the Work Behavior Inventory (WBI) [ Time Frame: Measured every 2 months for 1 year ] [ Designated as safety issue: No ]
  • Medication adherence [ Time Frame: Measured every 2 weeks for 1 year ] [ Designated as safety issue: No ]
  • Measured over 12 months: Cognitive performance on test battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery plus additional measures)
  • Return to work or school (SAS Work Section)
  • Maintenance of work/school attendance (SAS)
  • Quality of work or school functioning, as assessed by the Work Behavior Inventory (WBI)
  • Medication adherence
Complete list of historical versions of study NCT00333177 on ClinicalTrials.gov Archive Site
  • Measured over 12 months: Exacerbation or relapse of psychotic symptoms, as assessed by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
  • Retention in treatment [ Time Frame: Every 3 months ] [ 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: Every 6 months ] [ Designated as safety issue: No ]
  • Increased motivation for work/school [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Improved coping strategies [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Measured over 12 months: Exacerbation or relapse of psychotic symptoms, as assessed by the Brief Psychiatric Rating Scale (BPRS)
  • Retention in treatment
  • Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
  • Increased motivation for work/school
  • Improved coping strategies
Not Provided
Not Provided
 
Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia

This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.

Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. These symptoms make it difficult to maintain a job, participate in school, and keep up self-care. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. Antipsychotic medications, such as risperidone, and psychosocial treatments, such as cognitive enhancement training and health behavior training, are common, effective treatments for schizophrenia. This study will determine the effectiveness of various combinations of psychosocial therapy and risperidone treatment in improving work or school performance in people with first-episode schizophrenia.

Participants in this open label study will be randomly assigned to receive one of the following four combinations of an antipsychotic medication and a psychosocial treatment: cognitive enhancement training plus oral risperidone; cognitive enhancement training plus long-acting injectable risperidone; health behavior training plus oral risperidone; or health behavior training plus long-acting injectable risperidone. Cognitive enhancement training will entail 2 hours per week of computer-assisted training targeted at improving attention, memory, and problem-solving skills. Additionally, participants will attend a weekly 1-hour group meeting to learn how to apply these skills to work and school situations. Health behavior training will involve 3 hours per week of relaxation training, nutrition education, and physical exercise to enhance wellness. Participants assigned to receive oral risperidone will receive their medication in pill form at the dosage determined to be optimal by the study psychiatrist. Participants assigned to receive injectable risperidone will be given one injection every 2 weeks. Dosages will start at 25 mg per injection and will be adjusted as needed.

Treatment will continue for 1 year following dosage stabilization, which typically occurs 2 to 3 months following study entry. For the first 6 months, participants assigned to receive health behavior training will attend study visits once a week and participants assigned to receive cognitive enhancement training will attend study visits twice a week. For the final 6 months, all participants will attend study visits twice weekly. At each visit, participants will receive their assigned psychosocial treatment; attend group therapy; meet with a case manager for counseling and assessment of symptoms, work functioning, and social functioning; and meet with a psychiatrist to monitor medication response. Additional cognitive and health behavior measures will be taken every 6 months to assess treatment effectiveness.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
  • Behavioral: Cognitive remediation
    Cognitive remediation training includes computerized cognitive training plus learning skills group.
  • Behavioral: Health behavior training
    Health behavior training includes group skills training in nutrition, exercise, and relaxation.
  • Drug: Risperidone, administered orally
    Oral risperidone at dosage judged optimal by treating psychiatrist
    Other Name: Risperdal
  • Drug: Risperidone, administered via injection
    Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed
    Other Name: Risperdal Consta
  • Behavioral: Individual Placement and Support
    Supported education/employment
  • Experimental: 1
    Participants will receive cognitive remediation training plus injectable, long-acting risperidone.
    Interventions:
    • Behavioral: Cognitive remediation
    • Drug: Risperidone, administered via injection
    • Behavioral: Individual Placement and Support
  • Active Comparator: 2
    Participants will receive health behavior training plus injectable, long-acting risperidone.
    Interventions:
    • Behavioral: Health behavior training
    • Drug: Risperidone, administered via injection
    • Behavioral: Individual Placement and Support
  • Experimental: 3
    Participants will receive cognitive remediation training plus risperidone administered orally.
    Interventions:
    • Behavioral: Cognitive remediation
    • Drug: Risperidone, administered orally
    • Behavioral: Individual Placement and Support
  • Active Comparator: 4
    Participants will receive health behavior training plus risperidone administered orally.
    Interventions:
    • Behavioral: Health behavior training
    • Drug: Risperidone, administered orally
    • Behavioral: Individual Placement and Support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
  • First major episode of psychotic symptoms occurred within 2 years prior to study entry

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 use during last 6 months
  • Unable 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
 
NCT00333177
R01 MH037705-06, R01MH037705, DAHBR AD-P
Yes
Keith Nuechterlein, Ph.D., University of California, Los Angeles
University of California, Los Angeles
  • National Institute of Mental Health (NIMH)
  • 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
March 2013

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