A Comparison of Risperidone and Aripiprazole 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 risperidone and aripiprazole are second generation antipsychotics，but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole 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 Risperidone and Aripiprazole for Treatment|
- 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
- adverse drug reaction [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital ] [ Designated as safety issue: Yes ]Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement 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:||July 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.
Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks
Other Name: Aopai H20041507
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: NCT01813643
|The Second Xiangya Hospital of Central University|
|Changsha, Hunan, China, 410011|
|Study Director:||Wei Hao, MD., Ph.D.||Central South University|