A Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Study Overview
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Brief Summary
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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
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Methods:A Multiple-Center, Randomized, Double-Blind.

Official Title
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A Multiple-Center, Randomized, Double-Blind Study of Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Conditions
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Methamphetamine Dependence

Intervention / Treatment
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* Drug: paliperidone
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paliperidone<br>paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks. | Drug: paliperidone<br>* Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks<br>* Other names: Invega;|
| Active Comparator: .Risperidone<br>Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks | Drug: Risperidone<br>* Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks<br>* Other names: Risperdal H20070057;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of psychosis | Positive and Negative Syndrome Scale | up to 4 weeks. participants will be followed for the duration of hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical general status | Clinical general rating scale | up to 4 weeks. participants will be followed for the duration of hospital stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methamphetamine-Associated Psychosis, Aripiprazole, Risperidone