Validation of Receptor Occupancy Simulation

Completed

• Conditions: Dopamine Receptor Occupancy; Medication Satisfaction; Schizophrenia; Prolactin Level

• Registration Number: NCT01660880
• Lead Sponsor: Seoul National University Hospital

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 available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-09
• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dopamine receptor occupancy	72 hrs after the last administration	Measured using 11C-raclopride positron emission tomography

Secondary Outcome Measures

Name	Time	Method
Hamilton rating scale for depression	Baseline and 72 hours after the last administration	HAM-D score
Barnes akathisia scale	Baseline and 72 hours after the last administration	BAS score
Abnormal involuntary movement scale	Baseline and 72 hours after the last administration	AIMS score
Simpson-Angus scale	Baseline and 72 hours after the last administration	SAS score
Treatment satisfaction questionnaire for medication	Baseline and 72 hours after the last administration	TSQM score
Medication satisfaction questionnaire	Baseline and 72 hours after the last administration	MSQ score
N-back task	Baseline and 72 hours after the last administration	To measure the change in working memory performance
Prolactin level	Baseline and 72 hours after the last administration	To explore the effect of receptor occupancy on the blood prolactin level
Dopamine receptor occupancy	24 hrs after the last administration

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of