Panic DisorderNCT01371474
Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
An observational study of Panic Disorder, run by GlaxoSmithKline.
Trial summary
The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Paroxetine
- How many people
- 1,483 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jun 2008
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Japanese subjects with depression or in a depressed state who are considered appropriate to prescribe paroxetine tablet starting at 20mg/day according to the prescribing information
Who may be able to join
- Patients with depression or in a depressed state
- Patients who start taking paroxetine at 20mg a day
Who cannot join
- Patients who have been treated with paroxetine prior to this investigation
- Patients with hypersensitivity to paroxetine
- Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
- Concomitant use in patients taking pimozide
About this study
The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.
- Conditions
- Panic Disorder
- Being tested
- Paroxetine
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients prescribed PAXIL | Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period Receives: Drug: Paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
Measured: 12 weeks
Efficacy evaluation based on overall improvement
The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL.
Measured: 12 weeks
Efficacy evaluation based on severity by symptoms
At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders.
Measured: 12 weeks
Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)
The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment).
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 posted10 Jun 2011 (estimated)
- Study startApr 2006
- Primary completionMar 2008
- Study completionJun 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 GlaxoSmithKlineThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,483 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371474
- Sponsor's protocol ID
- 112308
- Status last verified
- May 2017
- First submitted
- 9 Jun 2011
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
- ClinicalTrials.gov ID
- NCT01371474
- Acronym / sponsor ID
- 112308
- Conditions
- Panic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,483 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Jun 2011 (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.
The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prescribed PAXIL | – | Drug: ParoxetinePatients with depression or in a depressed state starting PAXIL at 20 mg/day during study period |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese subjects with depression or in a depressed state who are considered appropriate to prescribe paroxetine tablet starting at 20mg/day according to the prescribing information
Key inclusion criteria (2 listed)
- Patients with depression or in a depressed state
- Patients who start taking paroxetine at 20mg a day
Key exclusion criteria (4 listed)
- Patients who have been treated with paroxetine prior to this investigation
- Patients with hypersensitivity to paroxetine
- Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
- Concomitant use in patients taking pimozide
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 |
|---|---|---|
| Paroxetine | Drug | Patients prescribed PAXIL |
Primary outcome
Incidence of adverse events
Time frame: 12 weeks
Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
Efficacy evaluation based on overall improvement
Time frame: 12 weeks
The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL.
Efficacy evaluation based on severity by symptoms
Time frame: 12 weeks
At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders.
Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)
Time frame: 12 weeks
The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment).
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 22 May 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder, run by GlaxoSmithKline.
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 2 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 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of adverse events (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 22 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.