A Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis
Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both paliperidone and risperidone are second generation antipsychotics，but have same pharmacological effects of antipsychotic treatment and paliperidone may have more efficacy and safty.This study was designed to examine the acute efficacy, safety, and tolerability of paliperidone and risperidone for patients with MAP.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multiple-Center, Randomized, Double-Blind Study of Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis|
- The severity of psychosis [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ] [ Designated as safety issue: Yes ]Positive and Negative Syndrome Scale
- Clinical general status [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ] [ Designated as safety issue: Yes ]Clinical general rating scale
|Study Start Date:||February 2013|
|Study Completion Date:||May 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.
Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks
Active Comparator: .Risperidone
Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks
Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
Other Name: Risperdal H20070057
Methods:A Multiple-Center, Randomized, Double-Blind.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822730
|The Second Xiangya Hospital of Central University|
|Changsha, Hunan, China, 410011|
|Study Director:||Wei Hao, MD., Ph.D.||Central South University|