Mental DisordersNCT01371435
Drug Use Investigation for PAXIL Tablet
An observational study of Mental Disorders, run by GlaxoSmithKline.
Trial summary
This post-marketing surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Paroxetine
- How many people
- 3,708 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Dec 2005
- 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/depressed state or panic disorder who were indicated for PAXIL
Who may be able to join
- Patients with depression/depressed state or panic disorder
Who cannot join
- Patients who had been taking PAXIL since before the start of the survey
- 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
This post-marketing surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine.
- Conditions
- Mental Disorders
- Being tested
- Paroxetine
- Medical subject headings
- Mental Disorders
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/depressed state or panic disorder prescribed PAXIL 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 in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
Measured: 8 weeks
Presence/absence of concomitant use of drugs metabolized by CYP2D6
PAXIL inhibits drug-metabolizing enzyme CYP2D6, and it takes about 1 week following discontinuation of PAXIL for this CYP2D6 function to recover from the inhibiting effect. Since it requires attention if drugs that are metabolized by CYP2D6 are administered during this recovery period, it was decided to investigate the presence/absence of use of drugs metabolized by CYP2D6 within 2 weeks after discontinuation of treatment in patients for whom treatment with PAXIL was discontinued, as well as the safety thereof.
Measured: Within 2 weeks after discontinuation or completion of treatment
Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; "SJW", hereinafter)
Although the action mechanism for this is not clear, SJW has been reported to have the action of inhibiting reuptake of serotonin, noradrenaline and dopamine, and to exhibit an antidepressant effect. Since PAXIL also acts to inhibit serotonin reuptake, concomitant use of products containing SJW is thought to have an effect upon the serotonin reuptake inhibiting action of PAXIL, so it was decided to check for concomitant use of products containing SJW and investigate the safety of such concomitant use.
Measured: 8 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 2001
- Primary completionSep 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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
- 3,708 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
- NCT01371435
- Sponsor's protocol ID
- 112301
- Status last verified
- May 2017
- First submitted
- 9 Jun 2011
- Last updated
- 8 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for PAXIL Tablet
- ClinicalTrials.gov ID
- NCT01371435
- Acronym / sponsor ID
- 112301
- Conditions
- Mental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,708 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Sep 2005 (actual)
- Study completion
- Dec 2005 (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.
This post-marketing surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prescribed PAXIL | – | Drug: ParoxetinePatients with depression/depressed state or panic disorder prescribed PAXIL during study period |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese subjects with depression/depressed state or panic disorder who were indicated for PAXIL
Key inclusion criteria (1 listed)
- Patients with depression/depressed state or panic disorder
Key exclusion criteria (4 listed)
- Patients who had been taking PAXIL since before the start of the survey
- 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 in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
Time frame: 8 weeks
Presence/absence of concomitant use of drugs metabolized by CYP2D6
Time frame: Within 2 weeks after discontinuation or completion of treatment
PAXIL inhibits drug-metabolizing enzyme CYP2D6, and it takes about 1 week following discontinuation of PAXIL for this CYP2D6 function to recover from the inhibiting effect. Since it requires attention if drugs that are metabolized by CYP2D6 are administered during this recovery period, it was decided to investigate the presence/absence of use of drugs metabolized by CYP2D6 within 2 weeks after discontinuation of treatment in patients for whom treatment with PAXIL was discontinued, as well as the safety thereof.
Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; "SJW", hereinafter)
Time frame: 8 weeks
Although the action mechanism for this is not clear, SJW has been reported to have the action of inhibiting reuptake of serotonin, noradrenaline and dopamine, and to exhibit an antidepressant effect. Since PAXIL also acts to inhibit serotonin reuptake, concomitant use of products containing SJW is thought to have an effect upon the serotonin reuptake inhibiting action of PAXIL, so it was decided to check for concomitant use of products containing SJW and investigate the safety of such concomitant use.
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 Jun 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 Mental Disorders, 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 1 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 Jun 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 in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice (time frame: 8 weeks). The study lists 3 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 8 Jun 2017.