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

This study is currently recruiting participants.
Verified March 2013 by Central South University
Sponsor:
Information provided by (Responsible Party):
Wei Hao, Central South University
ClinicalTrials.gov Identifier:
NCT01822730
First received: March 28, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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 Intervention Phase
Methamphetamine Dependence
Drug: paliperidone
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • The severity of psychosis [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ] [ Designated as safety issue: Yes ]
    Positive and Negative Syndrome Scale


Secondary Outcome Measures:
  • Clinical general status [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ] [ Designated as safety issue: Yes ]
    Clinical general rating scale


Estimated Enrollment: 240
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Risperdal H20070057

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822730

Contacts
Contact: Gang Wang, doctor 18684667092 visa8752@yahoo.com.cn

Locations
China, Hunan
The Second Xiangya Hospital of Central University Recruiting
Changsha, Hunan, China, 410011
Contact: Gang Wang, doctor    18684667092    visa8752@yahoo.com.cn   
Principal Investigator: Gang Wang, doctor         
Sponsors and Collaborators
Wei Hao
Investigators
Study Director: Wei Hao, MD., Ph.D. Central South University
  More Information

No publications provided

Responsible Party: Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
ClinicalTrials.gov Identifier: NCT01822730     History of Changes
Other Study ID Numbers: 100000-068943
Study First Received: March 28, 2013
Last Updated: March 28, 2013
Health Authority: China: Ethics Committee
China: National Natural Science Foundation
United States: Food and Drug Administration

Keywords provided by Central South University:
Methamphetamine-Associated Psychosis
Aripiprazole
Risperidone

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Methamphetamine
Risperidone
9-hydroxy-risperidone
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on April 15, 2014