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NCT Number: NCT01822730

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

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.

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Key information

Conditions

Methamphetamine Dependence

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Xiangya Hospital of Central University

Changsha, Hunan, 410011, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 paliperidone.
  • pregnancy and breastfeeding women.

Treatment and study plan

Paliperidone

Drug

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

Other names: Paliperidone Extended-Release Tablets, Invega

Risperidone

Drug

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

Other names: Risperdal H20070057

Primary outcomes

  1. The severity of psychosis

    Time frame: up to 4 weeks. participants will be followed for the duration of hospital stay

    Positive and Negative Syndrome Scale

Secondary outcomes

  1. Clinical general status

    Time frame: up to 4 weeks. participants will be followed for the duration of hospital stay

    Clinical general rating scale

Sponsors and collaborators

Lead sponsor

Wei Hao

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2013
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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