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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´╝îbut 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?

Methamphetamine Dependence

Study Interventions

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

Study Arms

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

Study Status

Completed

Start Date: February 2013

Completed Date: May 2014

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01822730

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