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

Phase 4

Completed

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

• Registration Number: NCT00333177
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2017-01-02
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-04
• Last Update Submitted: 2020-03-04
• Results First Posted: 2020-03-26
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cog Remediation, risperidone injection	Cognitive remediation training (CT)	Participants will receive cognitive remediation training plus risperidone, administered via injection.
Cog Remediation, risperidone injection	Risperidone, administered via injection (RLAI)	Participants will receive cognitive remediation training plus risperidone, administered via injection.
Healthy Behavior Training, risperidone injection	Healthy behavior training (HBT)	Participants will receive health behavior training plus risperidone, administered via injection.
Healthy Behavior Training, risperidone injection	Risperidone, administered via injection (RLAI)	Participants will receive health behavior training plus risperidone, administered via injection.
Cog Remediation, oral risperidone	Cognitive remediation training (CT)	Participants will receive cognitive remediation training plus risperidone administered orally.
Cog Remediation, oral risperidone	Risperidone, administered orally (Oral Ris)	Participants will receive cognitive remediation training plus risperidone administered orally.
Healthy Behavior Training, oral risperidone	Healthy behavior training (HBT)	Participants will receive health behavior training plus risperidone administered orally.
Healthy Behavior Training, oral risperidone	Risperidone, administered orally (Oral Ris)	Participants will receive health behavior training plus risperidone administered orally.

Primary Outcome Measures

Name	Time	Method
Average Medication Non-adherence	Averaged over study participation (up to 12 months)	5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, Medication Event Monitoring System (MEMS) cap readings, plasma assays, and psychiatrist judgements for oral risperidone and timing of injections for long-acting injectable risperidone. Averaged over medication study participation.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)	Measured at baseline and 12 months	Values presented here are the changes in MCCB Overall Composite T scores from baseline to 12 months, with higher values representing better outcome. Raw test scores are used to generate T-scores and then the seven MCCB domains are combined to generate an Overall Composite T score. MCCB Overall Composite T scores have a mean in the general population of 50 with a standard deviation of 10. Thus, a positive change of 5 T scores is an improvement of half a standard deviation.
Work/School Functioning (Global Functioning Scale: Role)	Baseline to 12 months	Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.

Secondary Outcome Measures

Name	Time	Method
Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)	12 months after randomization	Rating scale based on clinician's interview of patient to determine level of lack of awareness of having a mental disorder. Range is from 1 (Aware) to 5 (Unaware), so lower scores indicate better outcome.
Work Behavior Inventory (WBI) Quality of Work/School Performance	Baseline to 1 year	Change in rating on quality of work/school performance based on patient, employer, and/or teacher reports. The Quality of Work rating at baseline was subtracted from the same rating at 12 mos. Higher scores are better outcome.
Maintenance of Work/School Attendance	12 months	Modified Work Section of the Social Adjustment Scale (SAS) was used to calculate the total number of weeks in school or competitive work. Range of possible values is 0 to 52, with higher numbers being better outcome.
Retention in Treatment	12 months	Days after randomization that a participant continued to receive at least the assigned CT or HBT psychosocial treatment. If a participant needed to end the assigned medication condition (RLAI vs. Oral Ris), they continued in the psychosocial treatment so this outcome focused on the days in the assigned psychosocial treatment. Possible range is 1 to 365, with higher being a better outcome.
Change in Coping Strategies	Baseline to 12 months	Coping Response Inventory, which rates extent to which active coping strategies were used after a significant stressful life event. Range of possible scores is 1 to 4. Higher scores are better.
Exacerbation or Relapse of Psychotic Symptoms	Occurence after randomization and until end of study participation (up to 12 mos.)	Dichotomous measure: Presence of any of 3 psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring after randomization and until end of study participation (up to 12 months post baseline). BPRS was administered every two weeks throughout study participation.
Change in Motivation for Work/School	Baseline to 12 months	The Work Motivation scale is a factor score from the Work Personality Profile. The Work Personality Profile is a set of ratings based on interviewing the participant. Scores at each occasion can range from 8 to 32, with higher indicating better motivation. Scores reported here are changes from baseline to 12 months, which could range from -24 to 24 with higher being better.

Trial Locations

Locations (1)

Semel Institute for Neuroscience and Human Behavior at UCLA; 🇺🇸 Los Angeles, California, United States