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

Sponsor

Wei Hao (Other)

Overall Status

Completed

CT.gov ID

NCT01822730

Collaborator

(none)

120

Enrollment

Location

Arms

14.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence	Drug: paliperidone Drug: Risperidone	Phase 4

Detailed Description

Methods:A Multiple-Center, Randomized, Double-Blind.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: paliperidone paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.	Drug: paliperidone Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks Other Names: Paliperidone Extended-Release Tablets Invega
Active Comparator: .Risperidone Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks	Drug: Risperidone Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks Other Names: Risperdal H20070057

Arm

Intervention/Treatment

Experimental: paliperidone

paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.

Drug: paliperidone

Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks

Other Names:

Paliperidone Extended-Release Tablets

Invega

Active Comparator: .Risperidone

Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks

Drug: Risperidone

Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks

Other Names:

Risperdal H20070057

Outcome Measures

Primary Outcome Measures

The severity of psychosis [up to 4 weeks. participants will be followed for the duration of hospital stay]
Positive and Negative Syndrome Scale

Secondary Outcome Measures

Clinical general status [up to 4 weeks. participants will be followed for the duration of hospital stay]
Clinical general rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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