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

February 2, 2015 updated by: Wei Hao

A Multiple-Center, Randomized, Double-Blind Study of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second XiangYa Hospital Of Central University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • Invega
  • Paliperidone Extended-Release Tablets
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 4 weeks. participants will be followed for the duration of hospital stay

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Hao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100000-068943

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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