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

Condition(s) targeted: Schizophrenia

Intervention: Cognitive remediation (Behavioral); Health behavior training (Behavioral); Risperidone, administered orally (Drug); Risperidone, administered via injection (Drug); Individual Placement and Support (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Keith H. Nuechterlein, PhD, Principal Investigator, Affiliation: University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences

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.

Official title: Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Cognitive performance on test battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery plus additional measures)

Work or school functioning (Global Functioning Scale: Role)

Maintenance of work/school attendance (SAS)

Quality of work or school functioning, as assessed by the Work Behavior Inventory (WBI)

Medication adherence

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, California 90095, United States

Starting date: March 2006
Last updated: March 27, 2013