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

NCT01813643 | Terminated Phase 4 DMC

• 1 other identifier: 100000-068941
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine-Associated Psychosis; Aripiprazole; Risperidone

Outcome Measures

Primary Outcomes (1)

• The severity of psychosis

  Positive and Negative Syndrome Scale

  up to 4 weeks. participants will be followed for the duration of hospital stay

Secondary Outcomes (2)

• adverse drug reaction

  up to 4 weeks. participants will be followed for the duration of hospital

• Clinical general status

  up to 4 weeks. participants will be followed for the duration of hospital stay

Study Arms (2)

Aripiprazole

EXPERIMENTAL

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

Drug: Aripiprazole

Risperidone

ACTIVE COMPARATOR

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

Drug: Risperidone

Interventions

Risperidone DRUG

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

Also known as: Risperdal H20070057

Risperidone

Aripiprazole DRUG

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

Also known as: Aopai H20041507

Aripiprazole

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious organic disease.
• Suicide ideation or hurt others.
• Taking antipsychotic within two weeks before.
• drug allergy to Risperidone or Aripiprazole.
• pregnancy and breastfeeding women.

Sponsors & Collaborators

• Wei Hao: lead

Study Sites (1)

The Second Xiangya Hospital of Central University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Interventions

Risperidone; Aripiprazole

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wei Hao, MD., Ph.D.

  Central South University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Second Xiangya Hospital of Cental South University

Study Record Dates

• First Submitted: August 19, 2012
• First Posted: March 19, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

CN (1)