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

NCT00333177 | Completed Phase 4 Results DMC

• 3 other identifiers: R01MH037705-06R01MH037705DAHBR AD-P
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizoaffective Disorder, Depressed Type; Schizophreniform Disorder; First-Episode Schizophrenia; Supported Employment; Cognitive Remediation; Health Behavior Training; Antipsychotic Medication

Outcome Measures

Primary Outcomes (4)

• Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

  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.

  Measured at baseline and 12 months

• Work/School Functioning (Global Functioning Scale: Role)

  Change in role functioning from baseline to the 6 month point (rated on a scale from 1= Extreme Role Dysfunction to 10 = Superior Role Functioning) is presented here.

  Baseline to 6 months

• Average Medication Non-adherence

  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.

  Averaged over study participation (up to 12 months)

• Work/School Functioning (Global Functioning Scale: Role)

  Changes in role functioning from baseline to 12 months. Ratings on a 10-point scale with 10 being best.

  Baseline to 12 months

Secondary Outcomes (7)

• Work Behavior Inventory (WBI) Quality of Work/School Performance

  Baseline to 1 year

• Maintenance of Work/School Attendance

  12 months

• Exacerbation or Relapse of Psychotic Symptoms

  Occurence after randomization and until end of study participation (up to 12 mos.)

• Retention in Treatment

  12 months

• Awareness of Illness, as Assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)

  12 months after randomization

Study Arms (4)

Cog Remediation, risperidone injection

EXPERIMENTAL

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

Behavioral: Cognitive remediation training (CT); Drug: Risperidone, administered via injection (RLAI)

Healthy Behavior Training, risperidone injection

ACTIVE COMPARATOR

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

Behavioral: Healthy behavior training (HBT); Drug: Risperidone, administered via injection (RLAI)

Cog Remediation, oral risperidone

EXPERIMENTAL

Participants will receive cognitive remediation training plus risperidone administered orally.

Behavioral: Cognitive remediation training (CT); Drug: Risperidone, administered orally (Oral Ris)

Healthy Behavior Training, oral risperidone

ACTIVE COMPARATOR

Participants will receive health behavior training plus risperidone administered orally.

Behavioral: Healthy behavior training (HBT); Drug: Risperidone, administered orally (Oral Ris)

Interventions

Cognitive remediation training (CT) BEHAVIORAL

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

Cog Remediation, oral risperidone; Cog Remediation, risperidone injection

Healthy behavior training (HBT) BEHAVIORAL

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

Healthy Behavior Training, oral risperidone; Healthy Behavior Training, risperidone injection

Risperidone, administered orally (Oral Ris) DRUG

Oral risperidone at dosage judged optimal by treating psychiatrist

Also known as: Risperdal

Cog Remediation, oral risperidone; Healthy Behavior Training, oral risperidone

Risperidone, administered via injection (RLAI) DRUG

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

Also known as: Risperdal Consta

Cog Remediation, risperidone injection; Healthy Behavior Training, risperidone injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
• First major episode of psychotic symptoms occurred within 2 years prior to study entry

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Semel Institute for Neuroscience and Human Behavior at UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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.

  PMID: 32981534 DERIVED

• 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.

  PMID: 26107752 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Keith H. Nuechterlein, Ph.D., Principal Investigator
• Organization: University of California, Los Angeles

keithn@ucla.edu

(310) 825-0036

Study Officials

• Keith H. Nuechterlein, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: June 1, 2006
• First Posted: June 2, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 26, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)