A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis
- 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
- 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
- Serious organic disease.
- Suicide ideation or hurt others.
- Taking antipsychotic within two weeks before.
- drug allergy to Risperidone or Aripiprazole.
- pregnancy and breastfeeding women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risperidone Risperidone Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks. Aripiprazole Aripiprazole Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.
- Primary Outcome Measures
Name Time Method The severity of psychosis up to 4 weeks. participants will be followed for the duration of hospital stay Positive and Negative Syndrome Scale
- Secondary Outcome Measures
Name Time Method adverse drug reaction up to 4 weeks. participants will be followed for the duration of hospital Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale
Clinical general status up 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