Dopamine Receptor OccupancyNCT01660880
Validation of Receptor Occupancy Simulation
An observational study of Dopamine Receptor Occupancy and Medication Satisfaction, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Dopamine Receptor Occupancy, Medication Satisfaction, Prolactin Level
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with schizophrenia who is in the steady sate of antipsychotic treatment
Who may be able to join
- 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
Who cannot join
- Other psychiatric disorders rather than schizophrenia
- history of head trauma
- positive in urine hCG
- on antidepressant, anticholinergics or mood stabilizer
Trial locations and contacts
1 site in 1 country.
About this study
- 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
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aripiprazole | Patient group who is treated with aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine receptor occupancy
Measured using 11C-raclopride positron emission tomography
Measured: 72 hrs after the last administration
Secondary outcomes (10)
Hamilton rating scale for depression
HAM-D score
Measured: Baseline and 72 hours after the last administration
Barnes akathisia scale
BAS score
Measured: Baseline and 72 hours after the last administration
Abnormal involuntary movement scale
AIMS score
Measured: Baseline and 72 hours after the last administration
Simpson-Angus scale
SAS score
Measured: Baseline and 72 hours after the last administration
Treatment satisfaction questionnaire for medication
TSQM score
Measured: Baseline and 72 hours after the last administration
Medication satisfaction questionnaire
MSQ score
Measured: Baseline and 72 hours after the last administration
N-back task
To measure the change in working memory performance
Measured: Baseline and 72 hours after the last administration
Prolactin level
To explore the effect of receptor occupancy on the blood prolactin level
Measured: Baseline and 72 hours after the last administration
Dopamine receptor occupancy
Measured: 3 hrs after the last administration
Dopamine receptor occupancy
Measured: 24 hrs after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dopamine Receptor OccupancyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Soo Kwon, Seoul National University Hospital
- Investigators
- Jun Soo Kwon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660880
- Sponsor's protocol ID
- C-1205-094-410
- Other IDs
- A070001
- Status last verified
- Apr 2019
- First submitted
- 23 Jul 2012
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Receptor Occupancy Simulation
- ClinicalTrials.gov ID
- NCT01660880
- Acronym / sponsor ID
- C-1205-094-410
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aripiprazole | – | –Patient group who is treated with aripiprazole |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with schizophrenia who is in the steady sate of antipsychotic treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Other psychiatric disorders rather than schizophrenia
- history of head trauma
- positive in urine hCG
- on antidepressant, anticholinergics or mood stabilizer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dopamine receptor occupancy
Time frame: 72 hrs after the last administration
Measured using 11C-raclopride positron emission tomography
10 secondary outcomes
Hamilton rating scale for depression
Time frame: Baseline and 72 hours after the last administration
Barnes akathisia scale
Time frame: Baseline and 72 hours after the last administration
Abnormal involuntary movement scale
Time frame: Baseline and 72 hours after the last administration
Simpson-Angus scale
Time frame: Baseline and 72 hours after the last administration
Treatment satisfaction questionnaire for medication
Time frame: Baseline and 72 hours after the last administration
Medication satisfaction questionnaire
Time frame: Baseline and 72 hours after the last administration
N-back task
Time frame: Baseline and 72 hours after the last administration
Prolactin level
Time frame: Baseline and 72 hours after the last administration
Dopamine receptor occupancy
Time frame: 3 hrs after the last administration
Dopamine receptor occupancy
Time frame: 24 hrs after the last administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
Related trials for Dopamine Receptor Occupancy
Active, not recruitingPhase 1/2
Evaluation of D3 Receptor Occupancy Using FLUORTRIOPRIDE ([18F]FTP) PET/CT
D3 Dopamine Receptor, Cocaine-dependent
Not yet recruitingPhase 1/2
A Positron Emission Tomography (PET) Study to Evaluate Dopamine D2 and D3 Receptor Occupancy by SIPI6398
Schizophrenia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Soo Kwon, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dopamine Receptor Occupancy and Medication Satisfaction, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dopamine receptor occupancy (time frame: 72 hrs after the last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.