Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01451736|
Recruitment Status : Recruiting
First Posted : October 14, 2011
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia (Recent-onset)||Drug: paliperidone palmitate Drug: risperidone||Phase 4|
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 extrapyramidal side effects than older "typical" antipsychotics. Oral risperidone is an atypical antipsychotic medication that is very commonly used to control the symptoms of schizophrenia. Adherence to prescribed oral medication continues to be a major clinical issue. This study will determine the effectiveness of oral risperidone versus a long-acting injectible alternative, paliperidone palmitate, in treating people with first-episode schizophrenia. Impact on clinical symptoms and cognitive functioning will be examined.
Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting paliperidone palmitate 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 paliperidone palmitate once every 4 weeks. Dosages will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient oral 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 psychiatrist monitoring of medication response and side effects; group therapy meetings focused on everyday living skills; family education about schizophrenia; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms, work recovery, and social functioning.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: paliperidone palmitate (Invega Sustenna)
Participants will be provided paliperidone palmitate (Invega Sustenna), administered in injectible long-acting form, plus group skills training and case management
Drug: paliperidone palmitate
Other Name: Invega Sustenna
Active Comparator: oral risperidone
Participants will be provided oral risperidone, plus group skills training and case management
Other Name: Risperdal
- Exacerbation or relapse of psychotic symptoms [ Time Frame: Evaluated for 12 months ]Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)
- Cognitive functioning based on Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery [ Time Frame: Baseline to 12 months ]The Overall Composite Score from the MATRICS Consensus Cognitive Battery will be the primary cognitive outcome measure.
- Role Functioning [ Time Frame: Baseline to 12 months ]Role Functioning Scale (RFS; Goodman et al. 1993).
- Cognitive performance on test battery (MCCB) [ Time Frame: Measured at baseline and 12 months ]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.
- Insight (Awareness of Mental Disorder) [ Time Frame: Measured at baseline and 12 months ]Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
- Retention in treatment [ Time Frame: Measured at 12 months ]Retention in treatment
- Social functioning [ Time Frame: Baseline to 12 months ]Social Functioning Scale (Goodman et al., 1993)
- Emotional reactivity on psychophysiological measures [ Time Frame: Measured at baseline and 12 months ]Emotional reactivity on psychophysiological measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451736
|Contact: Kenneth L Subotnik, Ph.D.||(310) firstname.lastname@example.org|
|Contact: Luana Turner, Psy.D.||(310) email@example.com|
|United States, California|
|UCLA Semel Institute for Neuroscience and Human Behavior||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Keith H Nuechterlein, Ph.D. 310-825-0036 firstname.lastname@example.org|
|Contact: Kenneth L Subotnik, Ph.D. (310) 825-0334 email@example.com|
|Principal Investigator: Keith H Nuechterlein, Ph.D.|
|Sub-Investigator: Kenneth L Subotnik, Ph.D.|
|Principal Investigator:||Keith H Nuechterlein, Ph.D.||University of California, Los Angeles (UCLA) Semel Institute for Neuroscience and Human Behavior|