Pain Processing in Anxiety and Depression | NCT00560196

Studies
Pain Processing in Anxiety and Depression

NCT00560196

Sponsor

Danish Pain Research Center

Status

Completed

Last Update Posted

Jan 21, 2016Estimated

Enrollment

71Actual

Phase

Not provided

Conditions

Pain
Anxiety
Depression

Interventions

Observation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
1	Patients with panic anxiety disorder without pain	Other: Observation
2	Patients with depression without pain	Other: Observation
3	Healthy controls	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other		1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantitative sensory testing		3-4 hours

Secondary Outcomes

Measure	Description	Time Frame
Symptom checklist 92		3-4 hours
Hamilton Depression and Anxiety Rating Scale		3-4 hours
Major Depression Inventory

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with panic disorder or depression

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Outpatient clinic Primary care clinic Community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lise Gormsen, MD	Danish Pain Research Center, Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Pain Research Center, Aarhus University Hospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D001008	Anxiety Disorders
D003863	Depression
D009437	Neuralgia
D059350	Chronic Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided