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

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ClinicalTrials.gov Identifier: NCT01822730
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: paliperidone Drug: Risperidone Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2013
Primary Completion Date : January 2014
Study Completion Date : May 2014

Arms and Interventions

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:
  • 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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Clinical general status [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay ]
    Clinical general rating scale

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822730

China, Hunan
The Second Xiangya Hospital of Central University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Wei Hao
Study Director: Wei Hao, MD., Ph.D. Central South University
More Information

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
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Wei Hao, Central South University:
Methamphetamine-Associated Psychosis

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Paliperidone Palmitate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors