- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813643
A Comparison of Risperidone and Aripiprazole 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 Risperidone and Aripiprazole for Treatment
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Methods:A Multiple-Center, Randomized, Double-Blind.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
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
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
- Must sign a Information consent form.
- Required to provide detailed address and phone number
Exclusion Criteria:
- Serious organic disease.
- Suicide ideation or hurt others.
- Taking antipsychotic within two weeks before.
- drug allergy to Risperidone or Aripiprazole.
- 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: Aripiprazole
Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.
|
Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks
Other Names:
|
Active Comparator: Risperidone
Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks.
|
Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
Other Names:
|
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
|
adverse drug reaction
Time Frame: up to 4 weeks. participants will be followed for the duration of hospital
|
Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale
|
up to 4 weeks. participants will be followed for the duration of hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
August 19, 2012
First Submitted That Met QC Criteria
March 15, 2013
First Posted (Estimate)
March 19, 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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
- Risperidone
Other Study ID Numbers
- 100000-068941
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.
Clinical Trials on Methamphetamine Dependence
-
University of California, Los AngelesCompletedMethamphetamine Dependence in Remission | Continuous Methamphetamine Dependence
-
National Institute on Drug Abuse (NIDA)Not yet recruitingMethamphetamine-dependence | Methamphetamine Abuse
-
InterveXion Therapeutics, LLCNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine-dependence | Methamphetamine AbuseUnited States
-
Centre for Addiction and Mental HealthNot yet recruitingMethamphetamine-dependence | Methamphetamine AbuseCanada
-
InterveXion Therapeutics, LLCNational Institute on Drug Abuse (NIDA)Active, not recruitingMethamphetamine-dependence | Methamphetamine AbuseUnited States
-
University of ArkansasCompletedCharacterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot StudyMethamphetamine Dependence | Methamphetamine WithdrawalUnited States
-
University of KentuckyNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Dependence | Methamphetamine AbuseUnited States
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA)TerminatedMethamphetamine Dependence | Methamphetamine AbuseUnited States
-
University of CincinnatiNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Dependence | Methamphetamine AbuseUnited States, Canada
-
University of KentuckyNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Dependence | Methamphetamine AbuseUnited States
Clinical Trials on Risperidone
-
Rovi Pharmaceuticals LaboratoriesCompletedAcute SchizophreniaUnited States, Ukraine
-
Northwestern UniversityOrtho-McNeil Janssen Scientific Affairs, LLCCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Rovi Pharmaceuticals LaboratoriesCompletedSchizophrenia | Schizoaffective DisorderSpain, South Africa, Russian Federation, Croatia
-
Zogenix, Inc.CompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Zogenix, Inc.Completed
-
Janssen-Cilag S.p.A.CompletedSchizophrenia | Schizoaffective Disorder
-
Rovi Pharmaceuticals LaboratoriesRecruiting
-
Xijing HospitalUnknown
-
Hoffmann-La RocheCompleted
-
Janssen Korea, Ltd., KoreaCompleted