A Multiple-Center, Randomized, Double-Blind Study of Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis
Overview
- Phase
- Phase 4
- Intervention
- paliperidone
- Conditions
- Methamphetamine Dependence
- Sponsor
- Wei Hao
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The severity of psychosis
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
Methods:A Multiple-Center, Randomized, Double-Blind.
Investigators
Wei Hao
The Second Xiangya Hospital of Cental South University
Central South University
Eligibility Criteria
Inclusion Criteria
- •Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
- •Must sign a Information consent form.
- •Required to provide detailed address and phone number
Exclusion Criteria
- •Serious organic disease.
- •Suicide ideation or hurt others.
- •Taking antipsychotic within two weeks before.
- •drug allergy to Risperidone or paliperidone.
- •pregnancy and breastfeeding women.
Arms & Interventions
paliperidone
paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.
Intervention: paliperidone
.Risperidone
Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks
Intervention: Risperidone
Outcomes
Primary Outcomes
The severity of psychosis
Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay
Positive and Negative Syndrome Scale
Secondary Outcomes
- Clinical general status(up to 4 weeks. participants will be followed for the duration of hospital stay)