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

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Risperidone, administered via injection (RLAI); Drug: Risperidone, administered orally (Oral Ris); Behavioral: Cognitive remediation training (CT); Behavioral: Healthy behavior training (HBT)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00333177

R01MH037705-06

R01MH037705 (U.S. NIH Grant/Contract)

DAHBR AD-P

Details and patient eligibility

About

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.

Full 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 once 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 intelligence quotient (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 4 patient groups

Cog Remediation, risperidone injection

Experimental group

Description:

Participants will receive cognitive remediation training plus risperidone, administered via injection.

Treatment:

Behavioral: Cognitive remediation training (CT)

Drug: Risperidone, administered via injection (RLAI)

Healthy Behavior Training, risperidone injection

Active Comparator group

Description:

Participants will receive health behavior training plus risperidone, administered via injection.

Treatment:

Behavioral: Healthy behavior training (HBT)

Drug: Risperidone, administered via injection (RLAI)

Cog Remediation, oral risperidone

Experimental group

Description:

Participants will receive cognitive remediation training plus risperidone administered orally.

Treatment:

Behavioral: Cognitive remediation training (CT)

Drug: Risperidone, administered orally (Oral Ris)

Healthy Behavior Training, oral risperidone

Active Comparator group

Description:

Participants will receive health behavior training plus risperidone administered orally.

Treatment:

Behavioral: Healthy behavior training (HBT)

Drug: Risperidone, administered orally (Oral Ris)