SchizophreniaNCT01758887
Antipsychotic Discontinuation in High-risk Subjects
An observational study of Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Would be there any difference in dopamine synthesis between remitted clinical high risk subjects for psychosis and healthy control? What would happen to dopamine synthesis after antipsychotic discontinuation in clinical high risk subjects for psychosis? What about the dopamine synthesis in recurred clinical high risk… Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Sep 2016
- 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 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Clinical high risk subjects for psychosis who have been treated with antipsychotic medication so that reach to the remission.
Who may be able to join
- Diagnosed as a clinical High Risk
- Treated with antipsychotic drugs
- PSP1-5 (from SIPS criteria) <3 (severity index)for more than 6 months
- Had not experienced a symptomatic relapse in the 6 months
Who cannot join
- Significant abnormality in laboratory tests
- History of head trauma
Trial locations and contacts
1 site in 1 country.
About this study
- Would be there any difference in dopamine synthesis between remitted clinical high risk subjects for psychosis and healthy control?
- What would happen to dopamine synthesis after antipsychotic discontinuation in clinical high risk subjects for psychosis?
- What about the dopamine synthesis in recurred clinical high risk subjects for psychosis after the discontinuation?
Read the detailed description
After the antipsychotic medication discontinuation, we are going to assess the changes of the biological markers
- Conditions
- Schizophrenia
- 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 |
|---|---|---|
| Controls | Healthy control | |
| patients | clinical high risk subjects for psychosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presynaptic dopamine synthesis in the striatum
measured with [18F]DOPA positron emission tomography
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: administrative reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 0 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, MD PhD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758887
- Sponsor's protocol ID
- H-1207-055-417
- Status last verified
- Oct 2016
- First submitted
- 27 Dec 2012
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antipsychotic Discontinuation in High-risk Subjects
- ClinicalTrials.gov ID
- NCT01758887
- Acronym / sponsor ID
- H-1207-055-417
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: administrative reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 1 Jan 2013 (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.
- Would be there any difference in dopamine synthesis between remitted clinical high risk subjects for psychosis and healthy control?
- What would happen to dopamine synthesis after antipsychotic discontinuation in clinical high risk subjects for psychosis?
- What about the dopamine synthesis in recurred clinical high risk subjects for psychosis after the discontinuation?
Detailed description
After the antipsychotic medication discontinuation, we are going to assess the changes of the biological markers
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Healthy control |
| patients | – | –clinical high risk subjects for psychosis |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Clinical high risk subjects for psychosis who have been treated with antipsychotic medication so that reach to the remission.
Key inclusion criteria (4 listed)
- Diagnosed as a clinical High Risk
- Treated with antipsychotic drugs
- PSP1-5 (from SIPS criteria) <3 (severity index)for more than 6 months
- Had not experienced a symptomatic relapse in the 6 months
Key exclusion criteria (2 listed)
- Significant abnormality in laboratory tests
- History of head trauma
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
Presynaptic dopamine synthesis in the striatum
Time frame: baseline
measured with [18F]DOPA positron emission tomography
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: No
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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, MD PhD principal investigator
Seoul National University College of Medicine
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 Schizophrenia, 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 2 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: withdrawn, as of the sponsor's last update on 13 Oct 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Presynaptic dopamine synthesis in the striatum (time frame: baseline). 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 13 Oct 2016.