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

This study has been terminated.
(Effects of aripiprazole was not obvious and showed adverse reaction obviously)
Sponsor:
Information provided by (Responsible Party):
Wei Hao, Central South University
ClinicalTrials.gov Identifier:
NCT01813643
First received: August 19, 2012
Last updated: March 27, 2013
Last verified: March 2013
  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 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 Intervention Phase
Methamphetamine Dependence
Drug: Risperidone
Drug: Aripiprazole
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 Risperidone and Aripiprazole for Treatment

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:
  • adverse drug reaction [ Time Frame: up to 4 weeks. participants will be followed for the duration of hospital ] [ Designated as safety issue: Yes ]
    Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale

  • 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


Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 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 Aripiprazole.
  5. pregnancy and breastfeeding women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813643

Locations
China, Hunan
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
  More Information

No publications provided

Responsible Party: Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
ClinicalTrials.gov Identifier: NCT01813643     History of Changes
Other Study ID Numbers: 100000-068941
Study First Received: August 19, 2012
Last Updated: March 27, 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:
Methamphetamine
Risperidone
Aripiprazole
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 July 20, 2014