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

NCT ID: NCT00333177

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

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 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cog Remediation, risperidone injection

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

Group Type: EXPERIMENTAL

Cognitive remediation training (CT)

Intervention Type: BEHAVIORAL

Cognitive remediation training includes computerized cognitive training plus learning skills group.

Risperidone, administered via injection (RLAI)

Intervention Type: DRUG

Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed

Healthy Behavior Training, risperidone injection

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

Group Type: ACTIVE_COMPARATOR

Healthy behavior training (HBT)

Intervention Type: BEHAVIORAL

Healthy behavior training includes group skills training in nutrition, exercise, and relaxation.

Risperidone, administered via injection (RLAI)

Intervention Type: DRUG

Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed

Cog Remediation, oral risperidone

Participants will receive cognitive remediation training plus risperidone administered orally.

Group Type: EXPERIMENTAL

Cognitive remediation training (CT)

Intervention Type: BEHAVIORAL

Cognitive remediation training includes computerized cognitive training plus learning skills group.

Risperidone, administered orally (Oral Ris)

Intervention Type: DRUG

Oral risperidone at dosage judged optimal by treating psychiatrist

Healthy Behavior Training, oral risperidone

Participants will receive health behavior training plus risperidone administered orally.

Group Type: ACTIVE_COMPARATOR

Healthy behavior training (HBT)

Intervention Type: BEHAVIORAL

Healthy behavior training includes group skills training in nutrition, exercise, and relaxation.

Risperidone, administered orally (Oral Ris)

Intervention Type: DRUG

Oral risperidone at dosage judged optimal by treating psychiatrist

Interventions

Cognitive remediation training (CT)

Cognitive remediation training includes computerized cognitive training plus learning skills group.

Intervention Type: BEHAVIORAL

Healthy behavior training (HBT)

Healthy behavior training includes group skills training in nutrition, exercise, and relaxation.

Intervention Type: BEHAVIORAL

Risperidone, administered orally (Oral Ris)

Oral risperidone at dosage judged optimal by treating psychiatrist

Intervention Type: DRUG

Risperidone, administered via injection (RLAI)

Risperidone in injectable form every 2 weeks, starting with 25 mg and adjusted as needed

Intervention Type: DRUG

Other Intervention Names

Risperdal; Risperdal Consta

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Keith Nuechterlein, Ph.D.

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith H. Nuechterlein, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Locations

Semel Institute for Neuroscience and Human Behavior at UCLA

Los Angeles, California, United States

Countries

United States

References

Nuechterlein KH, Ventura J, Subotnik KL, Gretchen-Doorly D, Turner LR, Casaus LR, Luo J, Boucher ML, Hayata JN, Bell MD, Medalia A. A randomized controlled trial of cognitive remediation and long-acting injectable risperidone after a first episode of schizophrenia: improving cognition and work/school functioning. Psychol Med. 2022 Jun;52(8):1517-1526. doi: 10.1017/S0033291720003335. Epub 2020 Sep 28.

Reference Type: DERIVED

PMID: 32981534 (View on PubMed)

Subotnik KL, Casaus LR, Ventura J, Luo JS, Hellemann GS, Gretchen-Doorly D, Marder S, Nuechterlein KH. Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia. A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):822-9. doi: 10.1001/jamapsychiatry.2015.0270.

Reference Type: DERIVED

PMID: 26107752 (View on PubMed)

Other Identifiers

R01MH037705

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR AD-P

Identifier Type: REGISTRY

Identifier Source: secondary_id

R01MH037705-06

Identifier Type: NIH

Identifier Source: org_study_id

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