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

Primary Purpose

Methamphetamine Dependence

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

paliperidone

Risperidone

About this trial

This is an interventional treatment trial for Methamphetamine Dependence focused on measuring Methamphetamine-Associated Psychosis, Aripiprazole, Risperidone

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 paliperidone.
pregnancy and breastfeeding women.

Sites / Locations

The Second Xiangya Hospital of Central University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

paliperidone

.Risperidone

Arm Description

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

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

Outcomes

Primary Outcome Measures

The severity of psychosis

Positive and Negative Syndrome Scale

Secondary Outcome Measures

Clinical general status

Clinical general rating scale

Full Information

NCT ID

NCT01822730

First Posted

March 28, 2013

Last Updated

February 2, 2015

Sponsor

Wei Hao

1. Study Identification

Unique Protocol Identification Number

NCT01822730

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wei Hao

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Methamphetamine Dependence

Keywords

Methamphetamine-Associated Psychosis, Aripiprazole, Risperidone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

paliperidone

Arm Type

Experimental

Arm Description

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

Arm Title

.Risperidone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

paliperidone

Other Intervention Name(s)

Paliperidone Extended-Release Tablets, Invega

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Risperidone

Other Intervention Name(s)

Risperdal H20070057

Intervention Description

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

Primary Outcome Measure Information:

Title

The severity of psychosis

Description

Positive and Negative Syndrome Scale

Time Frame

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

Secondary Outcome Measure Information:

Title

Clinical general status

Description

Clinical general rating scale

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 paliperidone. pregnancy and breastfeeding women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Hao, MD., Ph.D.

Organizational Affiliation

Central South University

Official's Role

Study Director

Facility Information:

Facility Name

The Second Xiangya Hospital of Central University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

32296355

Citation

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.

Results Reference

derived

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

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