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

Methamphetamine Dependence Clinical Trial

Official title:

A Multiple-Center, Randomized, Double-Blind Study of Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822730
• Other study ID #: 100000-068943
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2013
• Last updated: February 2, 2015
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: National Natural Science FoundationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

Drug:
• paliperidone
Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks
• Risperidone
Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Wei Hao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of psychosis	Positive and Negative Syndrome Scale	up to 4 weeks. participants will be followed for the duration of hospital stay	Yes
Secondary	Clinical general status	Clinical general rating scale	up to 4 weeks. participants will be followed for the duration of hospital stay	Yes