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

NCT ID: NCT01813643

Last Updated: 2015-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Methamphetamine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aripiprazole

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

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks

Risperidone

Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks.

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks

Interventions

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Risperidone

Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks

Intervention Type DRUG

Aripiprazole

Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks

Intervention Type DRUG

Other Intervention Names

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Risperdal H20070057 Aopai H20041507

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wei Hao

OTHER

Sponsor Role lead

Responsible Party

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Wei Hao

The Second Xiangya Hospital of Cental South University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wei Hao, MD., Ph.D.

Role: STUDY_DIRECTOR

Central South University

Locations

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The Second Xiangya Hospital of Central University

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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100000-068941

Identifier Type: -

Identifier Source: org_study_id

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