Brain Myelination Effects of Paliperidone Palmitate Versus Oral Risperidone in First Episode Schizophrenia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Brain Myelination Effects of Paliperidone Palmitate vs. Oral Risperidone in First Episode Schizophrenia|
- Intracortical myelin [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in frontal lobe intracortical myelin The total frontal lobe intracortical myelin will be the primary outcome measure.
- Cognition [ Time Frame: 12 months ] [ Designated as safety issue: No ]Cognitive functioning based on CogState Battery The Complex Reaction Time measures of the CogState Battery will be secondary measures of cognitive outcome.
- Biomarker [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in other brain imaging biomarkers:
- total frontal lobe myelinated white matter volume determined on inversion recovery images,
- subcortical white matter integrity in orbitofrontal white matter and genu of corpus callosum assessed with radial diffusivity on diffusion tensor images and transvesre relaxation rate assessed with spin-echo images,
- whole brain white and gray matter volume changes assessed with vector based morphometry using 3D T1-weighted images
will be the imaging outcome measures.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: 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
Long acting injectable
Active Comparator: Active Comparator: oral risperidone
Participants will be provided oral risperidone, plus group skills training and case management
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 injectable alternative, paliperidone palmitate, in improving brain myelination and cognitive function in people with first-episode schizophrenia. Impact on brain myelination and clinical symptoms will be examined to test the hypothesis that brain myelination changes underlie one of the mechanisms of action of antipsychotics. This study will assess biomarkers at baseline (pre randomization), 6 months, and end of "parent study" participation.
Participants in the "parent" 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. Parent 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458379
|Contact: George Bartzokis, M.D.||firstname.lastname@example.org|
|United States, California|
|UCLA Semel Institute for Neuroscience and Human Behavior||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Contact: George Bartzokis, M.D. 310-206-3207 email@example.com|
|Sub-Investigator: George Bartzokis, M.D.|