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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01813656
Other study ID # 100000-068942
Secondary ID
Status Terminated
Phase Phase 4
First received November 28, 2012
Last updated February 2, 2015
Start date September 2012
Est. completion date February 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 substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics,but have different pharmacological effects of neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among mehtamphetamine addicts.


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date February 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 dependence.

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:
Aripiprazole
Aripiprazole group,5mg/pill,10mg/day non-forced titration method,last 12weeks
placebo
placebo group,5mg/pill,10mg/day non-forced titration method,last 12 weeks

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 abstinent time of Methamphetamine addict methamphetamine-positive urine test results,self-reports of substance use up to 3 months Yes
Secondary number of Participants with Adverse Events as a Measure of Safety and Tolerability use Abnormal Involuntary Movement Scale ,Simpson-Angus Scale and Barnes akathisia Scale up to 3 months Yes
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