A Comparison of Risperidone and Aripiprazole for Treatmen... | NCT01813643

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

NCT01813643

Sponsor

Wei Hao

Status

Terminated

Last Update Posted

Feb 4, 2015Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Methamphetamine Dependence

Interventions

Risperidone
Aripiprazole

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Effects of aripiprazole was not obvious and showed adverse reaction obviously

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Aug 2014Actual

First Submitted Date

Aug 19, 2012

First Submission Date that Met QC Criteria

Mar 15, 2013

First Posted Date

Mar 19, 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 risperidone and aripiprazole are second generation antipsychotics，but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole 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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aripiprazole	Experimental	Aripiprazole arm,5mg/pill,20-30mg/day,non-forced titration method.last2-4weeks.	Drug: Aripiprazole
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
Risperidone	Drug	Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks	Risperidone

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
adverse drug reaction	Barnes Scale , Simpson-Angus Scale , Abnormal Involuntary Movement Scale	up to 4 weeks. participants will be followed for the duration of hospital
Clinical general status

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 Aripiprazole.
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

Intervention Browse Module

MeSH Terms

ID	Term
D018967	Risperidone
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

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