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Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), May 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00333177
  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 IV

MedlinePlus related topics: Healthy Living Mental Health Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]
  • Return to work or school (SAS Work Section) [ 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 ]

Estimated Enrollment: 140
Study Start Date: March 2006
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
Behavioral: Individual Placement and Support
Supported education/employment
2: Active Comparator
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
Behavioral: Individual Placement and Support
Supported education/employment
3: Experimental
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
Behavioral: Individual Placement and Support
Supported education/employment
4: Active Comparator
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333177

Contacts
Contact: Rosemary Collier, MA 310-206-5090 rcollier@mednet.ucla.edu
Contact: Luana Turner, PsyD 310-974-7340 luana@ucla.edu

Locations
United States, California
Semel Institute for Neuroscience and Human Behavior at UCLA Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Keith H. Nuechterlein, PhD            
Sub-Investigator: Kenneth L. Subotnik, PhD            
Sub-Investigator: Joseph Ventura, PhD            
Sub-Investigator: John Luo, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Keith H. Nuechterlein, PhD University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
  More Information

Responsible Party: UCLA ( Keith H. Nuechterlein, PhD )
Study ID Numbers: R01 MH37705-06, DAHBR AD-P
Study First Received: June 1, 2006
Last Updated: May 5, 2008
ClinicalTrials.gov Identifier: NCT00333177  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Schizoaffective Disorder, Depressed Type
Schizophreniform Disorder
First-Episode Schizophrenia
Supported Employment
Cognitive Remediation
Health Behavior Training
Antipsychotic Medication

Study placed in the following topic categories:
Schizophrenia
Dopamine
Depression
Mental Disorders
Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 30, 2009