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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01813643
Other study ID # 100000-068941
Secondary ID
Status Terminated
Phase Phase 4
First received August 19, 2012
Last updated February 2, 2015
Start date July 2012
Est. completion date August 2014

Study information

Verified date February 2015
Source Central South University
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeChina: National Natural Science FoundationUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date August 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Risperidone
Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
Aripiprazole
Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks

Locations

Country Name City State
China The Second Xiangya Hospital of Central University Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Wei Hao

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The severity of psychosis Positive and Negative Syndrome Scale up to 4 weeks. participants will be followed for the duration of hospital stay Yes
Secondary adverse drug reaction Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale up to 4 weeks. participants will be followed for the duration of hospital Yes
Secondary Clinical general status Clinical general rating scale up to 4 weeks. participants will be followed for the duration of hospital stay Yes
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