Validation of Receptor Occupancy Simulation | NCT01660880

Studies
Validation of Receptor Occupancy Simulation

NCT01660880

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 8, 2019Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Dopamine Receptor Occupancy
Medication Satisfaction
Prolactin Level
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

ID	Type	Description	Link
A070001	Other Grant/Funding Number	The Korean Healthcare Technology R&D Project

Status Module

Record Verification Date

Apr 2019

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

Dec 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 23, 2012

First Submission Date that Met QC Criteria

Aug 6, 2012

First Posted Date

Aug 9, 2012Estimated

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

Apr 4, 2019

Last Update Posted Date

Apr 8, 2019Actual

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

To estimate dopamine receptor occupancy by aripiprazole using computer simulation
To measure dopamine receptor occupancy by aripiprazole in patients treated with the antipsychotics
To validate the simulation result by comparing the receptor occupancy from the simulation with that from the patients

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Label	Type	Description	Intervention Names
aripiprazole		Patient group who is treated with aripiprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dopamine receptor occupancy	Measured using 11C-raclopride positron emission tomography	72 hrs after the last administration

Secondary Outcomes

Measure	Description	Time Frame
Hamilton rating scale for depression	HAM-D score	Baseline and 72 hours after the last administration
Barnes akathisia scale	BAS score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of schizophrenia
treated with aripiprazole or risperidone
no change in dose of antipsychotics for at least 6 weeks
total PANSS score should be below 80

Exclusion Criteria:

Other psychiatric disorders rather than schizophrenia
history of head trauma
positive in urine hCG
on antidepressant, anticholinergics or mood stabilizer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Patients with schizophrenia who is in the steady sate of antipsychotic treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun Soo Kwon, M.D., Ph.D.	Seoul National University Hospital	Principal Investigator

Locations

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

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