Validation of Receptor Occupancy Simulation

April 4, 2019 updated by: Jun Soo Kwon, Seoul National University Hospital
  • 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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
aripiprazole
Patient group who is treated with aripiprazole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton rating scale for depression
Time Frame: Baseline and 72 hours after the last administration
HAM-D score
Baseline and 72 hours after the last administration
Barnes akathisia scale
Time Frame: Baseline and 72 hours after the last administration
BAS score
Baseline and 72 hours after the last administration
Abnormal involuntary movement scale
Time Frame: Baseline and 72 hours after the last administration
AIMS score
Baseline and 72 hours after the last administration
Simpson-Angus scale
Time Frame: Baseline and 72 hours after the last administration
SAS score
Baseline and 72 hours after the last administration
Treatment satisfaction questionnaire for medication
Time Frame: Baseline and 72 hours after the last administration
TSQM score
Baseline and 72 hours after the last administration
Medication satisfaction questionnaire
Time Frame: Baseline and 72 hours after the last administration
MSQ score
Baseline and 72 hours after the last administration
N-back task
Time Frame: Baseline and 72 hours after the last administration
To measure the change in working memory performance
Baseline and 72 hours after the last administration
Prolactin level
Time Frame: Baseline and 72 hours after the last administration
To explore the effect of receptor occupancy on the blood prolactin level
Baseline and 72 hours after the last administration
Dopamine receptor occupancy
Time Frame: 3 hrs after the last administration
3 hrs after the last administration
Dopamine receptor occupancy
Time Frame: 24 hrs after the last administration
24 hrs after the last administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (ESTIMATE)

August 9, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1205-094-410
  • A070001 (Other Grant/Funding Number: Korea National Enterprise For Clinical Trials)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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