Descriptive Study of Pain, Anxiety and Depression | NCT00378274

Studies
Descriptive Study of Pain, Anxiety and Depression

NCT00378274

Sponsor

Danish Pain Research Center

Status

Completed

Last Update Posted

Nov 16, 2007Estimated

Enrollment

75Estimated

Phase

Not provided

Conditions

Pain

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

Nov 2007

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

Sep 2006

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Sep 18, 2006

First Submission Date that Met QC Criteria

Sep 18, 2006

First Posted Date

Sep 19, 2006Estimated

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

Nov 15, 2007

Last Update Posted Date

Nov 16, 2007Estimated

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 chronic pain patients with and without neuropathic pain compared with healthy volunteers

Detailed Description

Primary outcome measures:

Symptom checklist 92

Secondary outcome measures:

Hamilton Depression and Anxiety Rating Scale
Major Depression Inventory
GAD-10 Anxiety Scale
Health Survey SF-36
McGill Pain Questionnaire
Sweat test
Heart rate variability testing
Coping Strategy Questionnare
Quantitative sensory testing
Pain Catastrophizing Scale
Pain rating (VAS)
Interview

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

75Estimated

Name	Type	Description	Arm Group Labels	Other Names
Observation	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Neuropathic pain patient or patient with fibromyalgia
Daily pain in more than 6 months
Weekly average pain score 4 or more (VAS)

Exclusion Criteria:

Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol
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

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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
D009437	Neuralgia
D059350	Chronic Pain
D003863	Depression
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010523	Peripheral Nervous System Diseases

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