A Comparison of Paliperidone and Risperidone for Treatmen... | NCT01822730

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

NCT01822730

Sponsor

Wei Hao

Status

Completed

Last Update Posted

Feb 4, 2015Estimated

Enrollment

120Actual

Phase

Phase 4

Conditions

Methamphetamine Dependence

Interventions

paliperidone
Risperidone

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jan 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Mar 28, 2013

First Submission Date that Met QC Criteria

Mar 28, 2013

First Posted Date

Apr 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2015

Last Update Posted Date

Feb 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
paliperidone	Drug	Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks	paliperidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Clinical general status	Clinical general rating scale	up to 4 weeks. participants will be followed for the duration of hospital stay

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei Hao, MD., Ph.D.	Central South University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Xiangya Hospital of Central University		Changsha	Hunan	410011	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32296355	Derived	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.

ID	Term
D000068882	Paliperidone Palmitate
D018967	Risperidone

ID	Term
D007555	Isoxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds