Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia

NCT01451736 | Completed Phase 4

• 3 other identifiers: P50 MH066286 Phase IIP50MH066286R092670SCH4005
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode schizophrenia.

Conditions

Schizophrenia (Recent-onset)

Keywords

First-episode Schizophrenia; Schizoaffective Disorder, Depressed Type (recent-onset); Schizophreniform Disorder; oral risperidone; long-acting injectable paliperidone palmitate; functional outcome

Outcome Measures

Primary Outcomes (3)

• Exacerbation or relapse of psychotic symptoms

  Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)

  Evaluated for 12 months

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

  The Overall Composite Score from the MATRICS Consensus Cognitive Battery will be the primary cognitive outcome measure.

  Baseline to 12 months

• Role Functioning

  Role Functioning Scale (RFS; Goodman et al. 1993).

  Baseline to 12 months

Secondary Outcomes (5)

• Cognitive performance on test battery (MCCB)

  Measured at baseline and 12 months

• Insight (Awareness of Mental Disorder)

  Measured at baseline and 12 months

• Retention in treatment

  Measured at 12 months

• Social functioning

  Baseline to 12 months

• Emotional reactivity on psychophysiological measures

  Measured at baseline and 12 months

Study Arms (2)

paliperidone palmitate (Invega Sustenna)

EXPERIMENTAL

Participants will be provided paliperidone palmitate (Invega Sustenna), administered in injectible long-acting form, plus group skills training and case management

Drug: paliperidone palmitate

oral risperidone

ACTIVE COMPARATOR

Participants will be provided oral risperidone, plus group skills training and case management

Drug: risperidone

Interventions

paliperidone palmitate DRUG

long-acting injectable

Also known as: Invega Sustenna

paliperidone palmitate (Invega Sustenna)

risperidone DRUG

oral

Also known as: Risperdal

oral risperidone

Eligibility Criteria

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

You may qualify if:

• A first episode of a psychotic illness is occurring or did occur within the last 2 years;
• A diagnosis by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition(DSM-IV)of schizophrenia, schizoaffective disorder, depressed type, or schizophreniform disorder; and
• Between 18 and 45 years of age.

You may not qualify if:

• Neurological disorder (e.g., epilepsy) or significant head injury;
• Significant alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
• Mental retardation, i.e. premorbid intelligence quotient (IQ) less than 70;
• Insufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal abilities;
• Residence likely to be outside of commuting distance of the University of California, Los Angeles (UCLA) Aftercare Research Program; or
• Patient has shown an inadequate response to an adequate previous trial of oral or long-acting injectable risperidone, paliperidone, or paliperidone palmitate.

Sponsors & Collaborators

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

Study Sites (1)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Paliperidone Palmitate; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Keith H Nuechterlein, Ph.D.

  University of California, Los Angeles (UCLA) Semel Institute for Neuroscience and Human Behavior

  PRINCIPAL INVESTIGATOR

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, Semel Institute for Neuroscience and Human Behavior

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

US (1)