A Comparison of Risperidone and Aripiprazole 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 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.

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 Risperidone and Aripiprazole for Treatment

Conditions
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Methamphetamine Dependence

Intervention / Treatment
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* Drug: Risperidone
* Drug: Aripiprazole


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 Aripiprazole. 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: Aripiprazole<br>Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks. | Drug: Aripiprazole<br>* Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks<br>* Other names: Aopai H20041507;|
| 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 |
| --- | --- | --- |
| adverse drug reaction | Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale | up to 4 weeks. participants will be followed for the duration of hospital | 
| 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