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

Sponsor
Wei Hao (Other)
Overall Status
Terminated
CT.gov ID
NCT01813643
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
25
Duration (Months)
2
Patients Per Site Per Month

Study Details

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 risperidone and aripiprazole are second generation antipsychotics，but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole for patients with MAP.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
50 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 Risperidone and Aripiprazole for Treatment
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aripiprazole

Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.

Drug: Aripiprazole
Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks
Other Names:
  • Aopai H20041507

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. adverse drug reaction [up to 4 weeks. participants will be followed for the duration of hospital]

      Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale

    2. Clinical general status [up to 4 weeks. participants will be followed for the duration of hospital stay]

      Clinical general rating scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    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 Aripiprazole.

    5. pregnancy and breastfeeding women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Xiangya Hospital of Central University Changsha Hunan China 410011

    Sponsors and Collaborators

    • Wei Hao

    Investigators

    • Study Director: Wei Hao, MD., Ph.D., Central South University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
    ClinicalTrials.gov Identifier:
    NCT01813643
    Other Study ID Numbers:
    • 100000-068941
    First Posted:
    Mar 19, 2013
    Last Update Posted:
    Feb 4, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
    Methamphetamine-Associated Psychosis
    Aripiprazole
    Risperidone
    Additional relevant MeSH terms:
    Risperidone
    Aripiprazole

    Study Results

    No Results Posted as of Feb 4, 2015