Methamphetamine Dependence | A Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis
Methamphetamine Dependence research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis. 2. Must sign a Information consent form. 3. Required to provide detailed address and phone number Exclusion Criteria: 1. Serious organic disease. 2. Suicide ideation or hurt others. 3. Taking antipsychotic within two weeks before. 4. drug allergy to Risperidone or paliperidone. 5. pregnancy and breastfeeding women.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:paliperidonePaliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks
Drug:RisperidoneRisperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
paliperidonepaliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.
.RisperidoneRisperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks
Start Date: February 2013
Completed Date: May 2014
Phase: Phase 4
Primary Outcome: The severity of psychosis
Secondary Outcome: Clinical general status
Study sponsors, principal investigator, and references
Principal Investigator: Wei Hao, MD., Ph.D.
Lead Sponsor: Wei Hao