Anxiety DisordersNCT01788553
Study Of Remission In Patients Treated For Generalized Anxiety Disorder
An observational study of Anxiety Disorders, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Belgium.
Trial summary
The aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. Factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- remission prevalence of generalized anxiety disorder
- How many people
- 750 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2006to Mar 2007
- 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 treated with generalized anxiety disorder in primary and specialized care in Belgium.
Who may be able to join
- To be eligible the patient must meet all of the following:
- Being treated for generalized anxiety disorder for approximately 3 months and not more than 12 months
- Be at least 18 years of age;
- Written informed consent
- Out-patient
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Remission in Patients Treated for Generalized Anxiety Disorder in Primary and Specialized Care in Belgium.
The aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. Factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be evaluated. The study will also assess patient functioning and compare functioning in patients who do and do not achieve remission.
Read the detailed description
The aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. Factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be evaluated. The study will also assess patient functioning and compare functioning in patients who do and do not achieve remission.
The objectives of the study are:
Primary: To determine the prevalence of remission in patients treated for generalized anxiety disorder in primary care and specialized care. Secondary: To determine patient functioning and work loss days and compare these in patients who do or do not achieve remission. To determine the effect of disease factors on remission rate such as disease history, duration, severity, co-morbidity with depression or other anxiety disorders. To determine the effect of treatment factors on remission rate such as setting, type of treatment, duration and adherence. To determine the effect of socio-demographic factors on remission rate such as gender, age, region (language), marital status, educational level and employment status.
This will be a cross-sectional observational study looking at the point prevalence of remission in treated patients with generalized anxiety disorder in general practice and specialized care in Belgium. General practitioners and psychiatrists will assess remission rates in patients treated for generalized anxiety disorder during 1 routine visit of these patients.
The participating physicians will have 3 months to evaluate remission at a routine visit in 5 to 10 patients that have been treated for generalized anxiety disorder since at least 3 months
- Conditions
- Anxiety Disorders
- Being tested
- remission prevalence of generalized anxiety disorder
- Keywords
- remission, generalized anxiety disorder
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remission prevalence of generalized anxiety disorderOther
| Study group | Role | What they receive |
|---|---|---|
| patients with generalized anxiety disorder | Not described Receives: Other: remission prevalence of generalized anxiety disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission of generalized anxiety disorder
Measured: 5 months
Secondary outcomes (1)
determine the effect of disease and treatment factors on remission rates
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMar 2006
- Primary completionMar 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788553
- Sponsor's protocol ID
- 0600B-102246
- Other IDs
- B2411129
- Status last verified
- Apr 2022
- First submitted
- 6 Jul 2009
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Remission in Patients Treated for Generalized Anxiety Disorder in Primary and Specialized Care in Belgium.
- ClinicalTrials.gov ID
- NCT01788553
- Acronym / sponsor ID
- 0600B-102246
- Conditions
- Anxiety Disorders
- Keywords
- remission, generalized anxiety disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006 (actual)
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 11 Feb 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.
The aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. Factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be evaluated. The study will also assess patient functioning and compare functioning in patients who do and do not achieve remission.
Detailed description
The aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. Factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be evaluated. The study will also assess patient functioning and compare functioning in patients who do and do not achieve remission.
The objectives of the study are:
Primary: To determine the prevalence of remission in patients treated for generalized anxiety disorder in primary care and specialized care. Secondary: To determine patient functioning and work loss days and compare these in patients who do or do not achieve remission. To determine the effect of disease factors on remission rate such as disease history, duration, severity, co-morbidity with depression or other anxiety disorders. To determine the effect of treatment factors on remission rate such as setting, type of treatment, duration and adherence. To determine the effect of socio-demographic factors on remission rate such as gender, age, region (language), marital status, educational level and employment status.
This will be a cross-sectional observational study looking at the point prevalence of remission in treated patients with generalized anxiety disorder in general practice and specialized care in Belgium. General practitioners and psychiatrists will assess remission rates in patients treated for generalized anxiety disorder during 1 routine visit of these patients.
The participating physicians will have 3 months to evaluate remission at a routine visit in 5 to 10 patients that have been treated for generalized anxiety disorder since at least 3 months
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with generalized anxiety disorder | – | Other: remission prevalence of generalized anxiety disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with generalized anxiety disorder in primary and specialized care in Belgium.
Key inclusion criteria (5 listed)
- Being treated for generalized anxiety disorder for approximately 3 months and not more than 12 months
- Be at least 18 years of age;
- Written informed consent
- Out-patient
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| remission prevalence of generalized anxiety disorder | Other | patients with generalized anxiety disorder |
Primary outcome
remission of generalized anxiety disorder
Time frame: 5 months
1 secondary outcome
determine the effect of disease and treatment factors on remission rates
Time frame: 5 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 3 May 2022.
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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 Anxiety Disorders, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Belgium.
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 5 inclusion and 0 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 3 May 2022. 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 Belgium. 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?
remission of generalized anxiety disorder (time frame: 5 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 3 May 2022.