Psoriatic ArthritisNCT00884468
Study Evaluating Anxiety and Depression in Patients With Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Spain.
Trial summary
This is an epidemiological non-interventional study assessing the prevalence of anxiety and/or depression disorders in patients suffering from Psoriatic Arthritis (PsA) in Spain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 384 participants
- Where
- 1 siteSpain
- Study dates
- May 2008to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PsA from outpatient's surgery or primary health care centres
Who may be able to join
- Patients both genders over 18 years old
- Patients with PsA diagnosis
Who cannot join
- Patients with PsA that suffer from other rheumatologic diseases or non-concomitant rheumatologic diseases that the investigator considers not to be appropriate for the study.
- Patients with any medical or physical condition (cognitive damage or difficulties for understanding) that create difficulties for reading and completing the questionnaires described in the protocol.
- Patients that in the study period are taking part in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anxiety and Depression in Patients With Psoriatic Arthritis: Prevalence and Characteristics
This is an epidemiological non-interventional study assessing the prevalence of anxiety and/or depression disorders in patients suffering from Psoriatic Arthritis (PsA) in Spain.
- Conditions
- Psoriatic Arthritis
- Keywords
- Anxiety and depression in patients with psoriatic arthritis
- Medical subject headings
- Arthritis, Psoriatic, Anxiety Disorders
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 |
|---|---|---|
| 1 | Patients with PsA that fulfill the eligibility criteria of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anxiety and/or depression disorders in patients suffering from PsA in Spain as measured by the Hospital Anxiety and Depression Scale (HAD)
Measured: 12 months
Secondary outcomes (1)
To assess the relation between the PsA severity and the presence of anxiety and/or depression disorders in patients suffering from PsA in Spain.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884468
- Sponsor's protocol ID
- 0881A5-4468
- Status last verified
- May 2009
- First submitted
- 16 Apr 2009
- Last updated
- 27 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Depression in Patients With Psoriatic Arthritis: Prevalence and Characteristics
- ClinicalTrials.gov ID
- NCT00884468
- Acronym / sponsor ID
- 0881A5-4468
- Conditions
- Psoriatic Arthritis
- Keywords
- Anxiety and depression in patients with psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Apr 2009 (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 is an epidemiological non-interventional study assessing the prevalence of anxiety and/or depression disorders in patients suffering from Psoriatic Arthritis (PsA) in Spain.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with PsA that fulfill the eligibility criteria of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PsA from outpatient's surgery or primary health care centres
Key inclusion criteria (2 listed)
- Patients both genders over 18 years old
- Patients with PsA diagnosis
Key exclusion criteria (3 listed)
- Patients with PsA that suffer from other rheumatologic diseases or non-concomitant rheumatologic diseases that the investigator considers not to be appropriate for the study.
- Patients with any medical or physical condition (cognitive damage or difficulties for understanding) that create difficulties for reading and completing the questionnaires described in the protocol.
- Patients that in the study period are taking part in another clinical trial.
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
Prevalence of anxiety and/or depression disorders in patients suffering from PsA in Spain as measured by the Hospital Anxiety and Depression Scale (HAD)
Time frame: 12 months
1 secondary outcome
To assess the relation between the PsA severity and the presence of anxiety and/or depression disorders in patients suffering from PsA in Spain.
Time frame: 12 months
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 27 May 2009.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
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 Psoriatic Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Spain.
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 3 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 27 May 2009. 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 Spain. 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?
Prevalence of anxiety and/or depression disorders in patients suffering from PsA in Spain as measured by the Hospital Anxiety and Depression Scale (HAD) (time frame: 12 months). 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 27 May 2009.