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

W

Wei Hao

Status and phase

Completed
Phase 4

Conditions

Methamphetamine Dependence

Treatments

Drug: paliperidone
Drug: Risperidone

Study type

Interventional

Funder types

Other

Identifiers

NCT01822730
100000-068943

Details and patient eligibility

About

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 paliperidone and risperidone are second generation antipsychotics,but have same pharmacological effects of antipsychotic treatment and paliperidone may have more efficacy and safty.This study was designed to examine the acute efficacy, safety, and tolerability of paliperidone and risperidone for patients with MAP.

Full description

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

Enrollment

120 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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 paliperidone.
  5. pregnancy and breastfeeding women.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

paliperidone
Experimental group
Description:
paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.
Treatment:
Drug: paliperidone
.Risperidone
Active Comparator group
Description:
Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks
Treatment:
Drug: Risperidone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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