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

Phase 4

Completed

• Conditions: Methamphetamine Dependence
• Interventions: Drug: Risperidone; Drug: paliperidone

• Registration Number: NCT01822730
• Lead Sponsor: Wei Hao

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-03-28
• Study First Posted: 2013-04-02
• Primary Completion: 2014-01
• Study Completion: 2014-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
.Risperidone	Risperidone	Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks
paliperidone	paliperidone	paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central University; 🇨🇳 Changsha, Hunan, China