Validation of Receptor Occupancy Simulation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01660880

Enrollment

Registered

2012-08-09

Start date

2012-12-31

Completion date

2014-04-30

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dopamine Receptor Occupancy, Medication Satisfaction, Prolactin Level, Schizophrenia

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Hamilton rating scale for depression	Baseline and 72 hours after the last administration	HAM-D 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	3 hrs after the last administration	—
Medication satisfaction questionnaire	Baseline and 72 hours after the last administration	MSQ score

Countries

South Korea

Outcome results