PainNCT00560196
Pain Processing in Anxiety and Depression
An observational study of Pain and Anxiety, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate pain, anxiety and depression in patients with panic anxiety disorders without pain or depression without pain compared with healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Depression
- What is being tested?
- Observation
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Feb 2009
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient clinic Primary care clinic Community sample
Who may be able to join
- Patients with panic disorder or depression
Who cannot join
- Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol, SSRI and benzodiazepines
- Serious or unstable medical disease
- Prior or present diagnosis of mania, bipolar or psychotic disorder, delirium, suicidal, drug and alcohol dependence, severe agitation
- Patients who cannot cooperate and do not understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Pain, Anxiety and Depression in Patients With Panic Anxiety Disorders Without Pain or Depression Without Pain Compared With Healthy Volunteers
The purpose of the study is to investigate pain, anxiety and depression in patients with panic anxiety disorders without pain or depression without pain compared with healthy volunteers
- Conditions
- Pain, Anxiety, Depression
- Being tested
- Observation
- Keywords
- Neuropathic pain, Chronic pain, Depression, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders, Depression, Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with panic anxiety disorder without pain Receives: Other: Observation | |
| 2 | Patients with depression without pain Receives: Other: Observation | |
| 3 | Healthy controls Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative sensory testing
Measured: 3-4 hours
Secondary outcomes (12)
Symptom checklist 92
Measured: 3-4 hours
Hamilton Depression and Anxiety Rating Scale
Measured: 3-4 hours
Major Depression Inventory
Measured: 3-4 hours
GAD-10 Anxiety Scale
Measured: 3-4 hours
Health Survey SF-36
Measured: 3-4 hours
McGill Pain Questionnaire
Measured: 3-4 hours
Sweat test
Measured: 3-4 hours
Heart rate variability testing
Measured: 3-4 hours
Coping Strategy Questionnaire
Measured: 3-4 hours
Pain Catastrophizing Scale
Measured: 3-4 hours
Pain rating (VAS)
Measured: 3-4 hours
Interview
Measured: 3-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise Gormsen, MD, Principal investigator, Danish Pain Research Center, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560196
- Sponsor's protocol ID
- PAD2007LG
- Status last verified
- Aug 2009
- First submitted
- 16 Nov 2007
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Anxiety and Depression in Patients With Panic Anxiety Disorders Without Pain or Depression Without Pain Compared With Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00560196
- Acronym / sponsor ID
- PAD2007LG
- Conditions
- Pain, Anxiety, Depression
- Keywords
- Neuropathic pain, Chronic pain, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Nov 2007 (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 purpose of the study is to investigate pain, anxiety and depression in patients with panic anxiety disorders without pain or depression without pain compared with healthy volunteers
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: ObservationPatients with panic anxiety disorder without pain |
| 2 | – | Other: ObservationPatients with depression without pain |
| 3 | – | Other: ObservationHealthy controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic Primary care clinic Community sample
Key inclusion criteria (1 listed)
- Patients with panic disorder or depression
Key exclusion criteria (4 listed)
- Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol, SSRI and benzodiazepines
- Serious or unstable medical disease
- Prior or present diagnosis of mania, bipolar or psychotic disorder, delirium, suicidal, drug and alcohol dependence, severe agitation
- Patients who cannot cooperate and do not understand Danish
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 |
|---|---|---|
| Observation | Other | 1, 2, 3 |
Primary outcome
Quantitative sensory testing
Time frame: 3-4 hours
12 secondary outcomes
Symptom checklist 92
Time frame: 3-4 hours
Hamilton Depression and Anxiety Rating Scale
Time frame: 3-4 hours
Major Depression Inventory
Time frame: 3-4 hours
GAD-10 Anxiety Scale
Time frame: 3-4 hours
Health Survey SF-36
Time frame: 3-4 hours
McGill Pain Questionnaire
Time frame: 3-4 hours
Sweat test
Time frame: 3-4 hours
Heart rate variability testing
Time frame: 3-4 hours
Coping Strategy Questionnaire
Time frame: 3-4 hours
Pain Catastrophizing Scale
Time frame: 3-4 hours
Pain rating (VAS)
Time frame: 3-4 hours
Interview
Time frame: 3-4 hours
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 21 Jan 2016.
Related trials for Pain
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
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.
Lise Gormsen, MD principal investigator
Danish Pain Research Center, Aarhus University Hospital
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 Pain and Anxiety, run by Danish Pain Research Center at 1 site in Denmark.
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 21 Jan 2016. 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 Denmark. 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?
Quantitative sensory testing (time frame: 3-4 hours). 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 21 Jan 2016.