Antipsychotic Discontinuation in High-risk Subjects | NCT01758887

Studies
Antipsychotic Discontinuation in High-risk Subjects

NCT01758887

Sponsor

Seoul National University Hospital

Status

Withdrawn

Last Update Posted

Oct 13, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Schizophrenia

Interventions

Not provided

Countries

South Korea

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

administrative reason

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Dec 27, 2012

First Submission Date that Met QC Criteria

Dec 27, 2012

First Posted Date

Jan 1, 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

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Would be there any difference in dopamine synthesis between remitted clinical high risk subjects for psychosis and healthy control?
What would happen to dopamine synthesis after antipsychotic discontinuation in clinical high risk subjects for psychosis?
What about the dopamine synthesis in recurred clinical high risk subjects for psychosis after the discontinuation?

Detailed Description

After the antipsychotic medication discontinuation, we are going to assess the changes of the biological markers

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Controls		Healthy control
patients		clinical high risk subjects for psychosis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presynaptic dopamine synthesis in the striatum	measured with [18F]DOPA positron emission tomography	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as a clinical High Risk
Treated with antipsychotic drugs
PSP1-5 (from SIPS criteria) <3 (severity index)for more than 6 months
Had not experienced a symptomatic relapse in the 6 months

Exclusion Criteria:

Significant abnormality in laboratory tests
History of head trauma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Clinical high risk subjects for psychosis who have been treated with antipsychotic medication so that reach to the remission.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun Soo Kwon, MD PhD	Seoul National University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided