Panic DisorderPhase 4NCT00767754
Changes of Cerebral Glucose Metabolism After 12 Weeks of Paroxetine Treatment in Panic Disorder
A Phase 4 study testing Paxil CR in people with Panic Disorder, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Paxil CR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Dec 2008
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- panic disorder 20-60 years
Who cannot join
- history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder, alcohol abuse and dependence, current regular use of benzodiazepines
- less than 17 on the HAM-D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Panic Disorder That Expresses to Change of Cerebral Glucose Metabolism After 12 Week of Paroxetine Treatment
Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary agent for treatment of panic disorder but there is little information on how paroxetine affects the brain function in patients with panic disorder.
The specific aim of this study is to examine the differences in brain activity between responders and nonresponders and to determine the predictor of paroxetine treatment in patients with panic disorder in terms of brain activity.
- Conditions
- Panic Disorder
- Being tested
- Paxil CR
- Keywords
- panic disorder, paroxetine, PET
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxil CRDrug
12 week treatment of Paxil(20-40mg)
| Study group | Role | What they receive |
|---|---|---|
| paroxetine cr | Other | single arm Receives: Drug: Paxil CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
18FDG PET, PDSS & HAM-A
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Bum-Hee Yu, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767754
- Sponsor's protocol ID
- SMC IRB 2006-07-091
- Status last verified
- Jul 2011
- First submitted
- 6 Oct 2008
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Panic Disorder That Expresses to Change of Cerebral Glucose Metabolism After 12 Week of Paroxetine Treatment
- ClinicalTrials.gov ID
- NCT00767754
- Acronym / sponsor ID
- SMC IRB 2006-07-091
- Conditions
- Panic Disorder
- Keywords
- panic disorder, paroxetine, PET
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Oct 2008 (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.
Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary agent for treatment of panic disorder but there is little information on how paroxetine affects the brain function in patients with panic disorder.
The specific aim of this study is to examine the differences in brain activity between responders and nonresponders and to determine the predictor of paroxetine treatment in patients with panic disorder in terms of brain activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paroxetine cr | Other | Drug: Paxil CRsingle arm |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- panic disorder 20-60 years
Key exclusion criteria (2 listed)
- history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder, alcohol abuse and dependence, current regular use of benzodiazepines
- less than 17 on the HAM-D
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paxil CR12 week treatment of Paxil(20-40mg) | Drug | paroxetine cr |
Primary outcome
18FDG PET, PDSS & HAM-A
Time frame: 12 weeks
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 25 Jul 2011.
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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.
Bum-Hee Yu, M.D., Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paxil CR in people with Panic Disorder, run by Samsung Medical Center 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 1 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: finished, as of the sponsor's last update on 25 Jul 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
18FDG PET, PDSS & HAM-A (time frame: 12 weeks). 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 25 Jul 2011.