NCT00560196

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

January 21, 2016

Status Verified

August 1, 2009

Enrollment Period

1.1 years

First QC Date

November 16, 2007

Last Update Submit

January 20, 2016

Conditions

PainAnxietyDepression

Keywords

Neuropathic painChronic painDepressionAnxiety

Outcome Measures

Primary Outcomes (1)

  • Quantitative sensory testing

    3-4 hours

Secondary Outcomes (12)

  • Symptom checklist 92

    3-4 hours

  • Hamilton Depression and Anxiety Rating Scale

    3-4 hours

  • Major Depression Inventory

    3-4 hours

  • GAD-10 Anxiety Scale

    3-4 hours

  • Health Survey SF-36

    3-4 hours

  • +7 more secondary outcomes

Study Arms (3)

1

Patients with panic anxiety disorder without pain

Other: Observation

2

Patients with depression without pain

Other: Observation

3

Healthy controls

Other: Observation

Interventions

ObservationOTHER
123

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient clinic Primary care clinic Community sample

You may qualify if:

  • Patients with panic disorder or depression

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

PainAnxiety DisordersDepressionNeuralgiaChronic Pain

Interventions

Observation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehaviorPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Lise Gormsen, MD

    Danish Pain Research Center, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

January 21, 2016

Record last verified: 2009-08

Locations

DK(1)