Antipsychotic to Treat Psychosis Syndrome | NCT02137616

Studies
Antipsychotic to Treat Psychosis Syndrome

NCT02137616

Sponsor

Central South University

Status

Unknown status

Last Update Posted

May 14, 2014Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Psychotic Disorders

Interventions

risperidone
olanzapine
Quetiapine
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

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

May 5, 2014

First Submission Date that Met QC Criteria

May 12, 2014

First Posted Date

May 14, 2014Estimated

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

May 12, 2014

Last Update Posted Date

May 14, 2014Estimated

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

This study assess the safety and effects of atypical antipsychotics in subjects with psychosis syndrome and psychosis risk syndrome.

Detailed Description

The investigators investigated whether administration of atypical antipsychotics could alleviate prodromal symptoms and be well tolerated by subjects with psychosis syndrome and psychosis risk syndrome.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
risperidone	Active Comparator	low dosage of antipsychotic drug	Drug: risperidone
olanzapine	Active Comparator	low doseage of antipsychotic	Drug: olanzapine
quetiapine	Active Comparator	low doseage of antipsychotic	Drug: Quetiapine
aripiprazole	Active Comparator	low doseage of antipsychotic	Drug: Aripiprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
risperidone	Drug	Risperdal tablets	risperidone	Risperidol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of PANSS total scores from baseline to 18 months		18 months

Secondary Outcomes

Measure	Description	Time Frame
Social function	Social function was assessed by the Global Assessment of Functioning (GAF) every three month	18 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

were help-seeking young individuals in outpatients service
aged 16-30 years
fitted one of the following Criteria: Psychosis-risk Syndromes (COPS-SIPS) or Psychotic Syndrome (POPS-SIPS) or DSM-IV diagnosis of schizophreniform disorder

Exclusion Criteria:

a previous diagnosis of any psychotic disorder or bipolar disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
symptoms fully accounted for by an Axis 1 disorder or sequelae of drug/alcohol use;
neurological disorders or organic disorders affecting the central nervous system, substance-related disorders or mental retardation as defined by the DSM-IV criteria;
history treatment of antipsychotic or antidepression, mood stabilizers or electroconvulsive therapy;
diagnosed as having a serious and unstable medical condition.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xiaofeng Guo, Dr.	Contact	073185554052	073185554052	fengcsu@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
xiaofeng Guo, Dr	the second xiangya hospitcal	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Second Xiangya Hospital	Recruiting	Changsha	Hunan	410011	China

Condition Browse Module

MeSH Terms

ID	Term
D011618	Psychotic Disorders
D013577	Syndrome

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D004194	Disease
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018967	Risperidone
D000077152	Olanzapine
D000069348	Quetiapine Fumarate
D000068180	Aripiprazole

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided