Schizophrenia (Recent-onset) Clinical Trial
Official title:
Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia
Verified date | April 2022 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 146 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Semel Institute for Neuroscience and Human Behavior | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Janssen Scientific Affairs, LLC, National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Role Functioning | Role Functioning Scale (RFS; Goodman et al. 1993). | Baseline to 12 months | |
Secondary | Cognitive performance on test battery (MCCB) | The cognitive domain scores from the MATRICS Consensus Cognitive Battery (MCCB) will be used as secondary measures to identify the domains in which treatment effects occurred. | Measured at baseline and 12 months | |
Secondary | Insight (Awareness of Mental Disorder) | Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R) | Measured at baseline and 12 months | |
Secondary | Retention in treatment | Retention in treatment | Measured at 12 months | |
Secondary | Social functioning | Social Functioning Scale (Goodman et al., 1993) | Baseline to 12 months | |
Secondary | Emotional reactivity on psychophysiological measures | Emotional reactivity on psychophysiological measures | Measured at baseline and 12 months |