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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Behavioral: Cognitive remediation
Behavioral: Health behavior training
Drug: Risperidone, administered orally
Drug: Risperidone, administered via injection
Behavioral: Individual Placement and Support
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: Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 153
Study Start Date: March 2006
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive cognitive remediation training plus injectable, long-acting risperidone.
Behavioral: Cognitive remediation
Cognitive remediation training includes computerized cognitive training plus learning skills group.
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
Active Comparator: 2
Participants will receive health behavior training plus injectable, long-acting risperidone.
Behavioral: Health behavior training
Health behavior training includes group skills training in nutrition, exercise, and relaxation.
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: 3
Participants will receive cognitive remediation training plus risperidone administered orally.
Behavioral: Cognitive remediation
Cognitive remediation training includes computerized cognitive training plus learning skills group.
Drug: Risperidone, administered orally
Oral risperidone at dosage judged optimal by treating psychiatrist
Other Name: Risperdal
Behavioral: Individual Placement and Support
Supported education/employment
Active Comparator: 4
Participants will receive health behavior training plus risperidone administered orally.
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
Behavioral: Individual Placement and Support
Supported education/employment

Detailed Description:

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.

  Eligibility

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

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
  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: NCT00333177

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
Janssen Scientific Affairs, LLC
Investigators
Principal Investigator: Keith H. Nuechterlein, PhD University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
  More Information

No publications provided

Responsible Party: Keith Nuechterlein, Ph.D., Prinicipal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00333177     History of Changes
Other Study ID Numbers: R01 MH037705-06, R01MH037705, DAHBR AD-P
Study First Received: June 1, 2006
Last Updated: March 27, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Schizoaffective Disorder, Depressed Type
Schizophreniform Disorder
First-Episode Schizophrenia
Supported Employment
Cognitive Remediation
Health Behavior Training
Antipsychotic Medication

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