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

Phase 4
Terminated
Conditions
Methamphetamine Dependence
Interventions
Registration Number
NCT01813643
Lead Sponsor
Wei Hao
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.

Detailed Description

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

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
50
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RisperidoneRisperidoneRisperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks.
AripiprazoleAripiprazoleAripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.
Primary Outcome Measures
NameTimeMethod
The severity of psychosisup to 4 weeks. participants will be followed for the duration of hospital stay

Positive and Negative Syndrome Scale

Secondary Outcome Measures
NameTimeMethod
adverse drug reactionup to 4 weeks. participants will be followed for the duration of hospital

Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale

Clinical general statusup to 4 weeks. participants will be followed for the duration of hospital stay

Clinical general rating scale

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central University

🇨🇳

Changsha, Hunan, China

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