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

NCT01822730 | Completed Phase 4 DMC

• 1 other identifier: 100000-068943
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine-Associated Psychosis; Aripiprazole; Risperidone

Outcome Measures

Primary Outcomes (1)

• The severity of psychosis

  Positive and Negative Syndrome Scale

  up to 4 weeks. participants will be followed for the duration of hospital stay

Secondary Outcomes (1)

• Clinical general status

  up to 4 weeks. participants will be followed for the duration of hospital stay

Study Arms (2)

paliperidone

EXPERIMENTAL

paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.

Drug: paliperidone

.Risperidone

ACTIVE COMPARATOR

Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks

Drug: Risperidone

Interventions

paliperidone DRUG

Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks

Also known as: Paliperidone Extended-Release Tablets, Invega

paliperidone

Risperidone DRUG

Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks

Also known as: Risperdal H20070057

.Risperidone

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious organic disease.
• Suicide ideation or hurt others.
• Taking antipsychotic within two weeks before.
• drug allergy to Risperidone or paliperidone.
• pregnancy and breastfeeding women.

Sponsors & Collaborators

• Wei Hao: lead

Study Sites (1)

The Second Xiangya Hospital of Central University

Changsha, Hunan, 410011, China

Location

Related Publications (1)

• Wang G, Ding F, Chawarski MC, Hao W, Liu X, Deng Q, Ouyang X. Randomized Controlled Trial of Paliperidone Extended Release Versus Risperidone for the Treatment of Methamphetamine-Associated Psychosis in Chinese Patients. Front Psychiatry. 2020 Apr 1;11:237. doi: 10.3389/fpsyt.2020.00237. eCollection 2020.

  PMID: 32296355 DERIVED

MeSH Terms

Interventions

Paliperidone Palmitate; Risperidone

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pyrimidinones

Study Officials

• Wei Hao, MD., Ph.D.

  Central South University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Second Xiangya Hospital of Cental South University

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 2, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

CN (1)