Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia

NCT00330551 | Completed Phase 4 Results DMC

• 3 other identifiers: P50MH066286DATR A2-AISZJanssen RIS-NAP-4009
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

Conditions

Schizophrenia

Keywords

Schizoaffective Disorder, Depressed Type; Schizophreniform Disorder; First-episode Schizophrenia; Injectable Risperidone

Outcome Measures

Primary Outcomes (5)

• Medication Adherence

  5-point scale (1 = best adherence, 5= nonadherent) based on pill counts, MEMS cap readings, plasma assays, and psychiatrist judgments for oral risperidone and timing of injections for long-acting injectable risperidone averaged over study participation

  Measured weekly throughout study participation, averaged over study participation

• Number of Participants Who Had an Exacerbation or Relapse of Psychotic Symptoms

  Dichotomous measure: Presence of any of three psychotic relapse or exacerbation categories scored from the Brief Psychiatric Rating Scale (BPRS) occurring any time after randomization and until end of study participation (up to 12 mos.).

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

• Number of Participants Who Returned to Work or School (SAS Work Section)

  The Social Adjustment Scale records the return to work or school and the number of weeks in work or school during each 3-month period. For this outcome, outcome as dichotomized as 0 if an individual did not return to work or school and 1 if they did return to competitive work or regular school enrollment.

  Measured from Baseline to Month 12

• Number of Weeks Maintaining Work or School (SAS)

  Measured as the number of weeks in which a participant has competitive employment or attends regular school courses. Possible range is 0 to 52 weeks.

  Cumulative total measured from Baseline to Month 12

• Change in Global Functioning Scale: Role

  10-point scale of work/school functioning. Scale range is from 1 (extreme role dysfunction) to 10 (superior role functioning). Measured by subtracting the baseline rating from the rating at 12 months.

  Measured at Baseline and Month 12

Secondary Outcomes (4)

• MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score

  Measured at baseline and 12 months

• Emotional Reactivity on Psychophysiological Measures

  Measured from Baseline to Month 12

• Retention in Treatment

  From baseline to 12 months

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

  Baseline to 12 months

Study Arms (2)

Long-acting injectible risperidone

EXPERIMENTAL

Participants who are randomly assigned to this arm will be administered the long-acting injectible form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.

Drug: Risperidone in Long-Acting Injectable Form (Consta)

Oral risperidone

ACTIVE COMPARATOR

Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months.

Drug: Oral Risperidone

Interventions

Oral Risperidone DRUG

Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.

Also known as: Risperdal

Oral risperidone

Risperidone in Long-Acting Injectable Form (Consta) DRUG

Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.

Also known as: Risperdal Consta

Long-acting injectible risperidone

Eligibility Criteria

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

You may qualify if:

• DSM-IV diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
• First major episode of psychotic symptoms occurred within 2 years prior to study entry
• Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia

You may not qualify if:

• Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
• Mental retardation (e.g., premorbid IQ less than 70)
• Significant alcohol or substance abuse within 6 months prior to study entry
• Inability 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)

• 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

• Bartzokis G, Lu PH, Amar CP, Raven EP, Detore NR, Altshuler LL, Mintz J, Ventura J, Casaus LR, Luo JS, Subotnik KL, Nuechterlein KH. Long acting injection versus oral risperidone in first-episode schizophrenia: differential impact on white matter myelination trajectory. Schizophr Res. 2011 Oct;132(1):35-41. doi: 10.1016/j.schres.2011.06.029. Epub 2011 Jul 20.

  PMID: 21767934 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

Limitations and Caveats

This trial used oral risperidone as the comparator to allow a strong comparison between oral and long-acting injectable forms of the same drug. Generalization of results to other oral antipsychotic medications was not assessed.

Results Point of Contact

• Title: Keith Nuechterlein, PhD
• 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: Professor, University of California, Los Angeles

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: March 1, 2006
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 1, 2023
• Results First Posted: March 23, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)