Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia

February 4, 2023 updated by: Keith Nuechterlein, Ph.D., University of California, Los Angeles

Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer adverse side effects than older "typical" antipsychotics. Risperidone is a type of atypical antipsychotic medication that is used to control the symptoms of schizophrenia. This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of risperidone once every 2 weeks. Dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. Study visits will occur once weekly throughout the study. They will include group therapy meetings focused on everyday living skills; family education about schizophrenia; assessments of medication response; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Semel Institute for Neuroscience and Human Behavior at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long-acting injectible risperidone
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)
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.
Other Names:
  • Risperdal Consta
Active Comparator: Oral risperidone
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
Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.
Other Names:
  • Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence
Time Frame: Measured weekly throughout study participation, averaged over study participation
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
Time Frame: Occurrence after randomization and until end of study participation (up to 12 mos.)
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)
Time Frame: Measured from Baseline to Month 12
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)
Time Frame: Cumulative total measured from Baseline to Month 12
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
Time Frame: Measured at Baseline and Month 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T Score
Time Frame: Measured at baseline and 12 months
The MCCB Overall Composite T score is computed by the MCCB Computer Scoring Program from the raw scores for 10 individual cognitive tests. The mean for the general population of comparable age and sex is 50 with a standard deviation of 10. Higher scores indicate better cognitive functioning. The outcome measure was the change from baseline to 12 months, calculated as 12-month T score minus baseline T score. Higher values indicate better outcome.
Measured at baseline and 12 months
Emotional Reactivity on Psychophysiological Measures
Time Frame: Measured from Baseline to Month 12
Electrodermal reactivity to pictures of negative versus neutral stimuli was the initially proposed measure. Larger skin conductance increases in response to negative pictures compared to neutral pictures would indicate stronger emotional reactivity.
Measured from Baseline to Month 12
Retention in Treatment
Time Frame: From baseline to 12 months
Number of days on the randomized medication before being switched to a different antipsychotic medication or dropping out of the medication trial. Possible range is 0 to 365, with higher numbers indicating better 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)
Time Frame: Baseline to 12 months
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.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Mental Health (NIMH)
Janssen Scientific Affairs, LLC

Investigators

  • Principal Investigator: Keith H. Nuechterlein, PhD, University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P50MH066286 (U.S. NIH Grant/Contract)
  • DATR A2-AISZ (World Health Organization ICTRP)
  • Janssen RIS-NAP-4009 (Other Grant/Funding Number: Janssen Scientific Affairs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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