A Multiple-Center, Randomized, Double-Blind Study of Comparison of Risperidone and Aripiprazole for Treatment
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The severity of psychosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Serious organic disease.
- •Suicide ideation or hurt others.
- •Taking antipsychotic within two weeks before.
- •drug allergy to Risperidone or Aripiprazole.
- •pregnancy and breastfeeding women.
Arms & Interventions
Risperidone
Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks.
Intervention: Risperidone (Drug)
Aripiprazole
Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.
Intervention: Aripiprazole (Drug)
Outcomes
Primary Outcomes
The severity of psychosis
Time Frame: up to 4 weeks. participants will be followed for the duration of hospital stay
Positive and Negative Syndrome Scale
Secondary Outcomes
- 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)
Investigators
Wei Hao
The Second Xiangya Hospital of Cental South University
Central South University