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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborators: Janssen Scientific Affairs, LLC; National Institute of Mental Health (NIMH)
• Treatments: Paliperidone Palmitate; Risperidone

Criteria

Inclusion Criteria:

1. A first episode of a psychotic illness is occurring or did occur within the last 2 years;

2. A diagnosis by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition(DSM-IV)of schizophrenia, schizoaffective disorder, depressed type, or schizophreniform disorder; and

3. Between 18 and 45 years of age.

Exclusion Criteria:

1. Neurological disorder (e.g., epilepsy) or significant head injury;

2. 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;

3. Mental retardation, i.e. premorbid intelligence quotient (IQ) less than 70;

4. Insufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal abilities;

5. Residence likely to be outside of commuting distance of the University of California, Los Angeles (UCLA) Aftercare Research Program; or

6. Patient has shown an inadequate response to an adequate previous trial of oral or long-acting injectable risperidone, paliperidone, or paliperidone palmitate.