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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01822730

Enrollment

120

Registered

2013-04-02

Start date

2013-02-28

Completion date

2014-05-31

Last updated

2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine-Associated Psychosis, Aripiprazole, Risperidone

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.

Interventions

DRUGpaliperidone

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

DRUGRisperidone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026