Clinical trial NCT00333177: Psychosocial Therapy and Risperidone Treatment in Work Performance in Recent-Onset Schizophrenia
Official title: Developmental Processes in Schizophrenic Disorders: Cognitive Remediation, Medication Adherence, and Work Outcome in Recent-Onset Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizoaffective Disorder, Depressed Type
Schizophreniform Disorder
First-Episode Schizophrenia
Supported Employment
Cognitive Remediation
Health Behavior Training
Antipsychotic Medication
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Janssen Scientific Affairs, LLC
First posted: 2006-06-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: Measured at baseline and 12 months
measure: Work/School Functioning (Global Functioning Scale: Role)
timeFrame: Baseline to 6 months
measure: Average Medication Non-adherence
timeFrame: Averaged over study participation (up to 12 months)
measure: Work/School Functioning (Global Functioning Scale: Role)
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Work Behavior Inventory (WBI) Quality of Work/School Performance
timeFrame: Baseline to 1 year
measure: Maintenance of Work/School Attendance
timeFrame: 12 months
measure: Exacerbation or Relapse of Psychotic Symptoms
timeFrame: Occurence after randomization and until end of study participation (up to 12 mos.)
measure: Retention in Treatment
timeFrame: 12 months
measure: Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
timeFrame: 12 months after randomization
measure: Change in Motivation for Work/School
timeFrame: Baseline to 12 months
measure: Change in Coping Strategies
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Semel Institute for Neuroscience and Human Behavior at UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
name: Keith H. Nuechterlein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.