Immune Patterns in Pain Patients DSM-IV
IPPPDIV
Phase 1 Study of Immune, Psychometric and Sociodemographic Patterns in Pain Patients Classified by DSM-IV
1 other identifier
observational
52
1 country
1
Brief Summary
The purpose of this study is to define subgroups of patients with somatoform disorders due to DSM-IV by immunological, psychological and genetic characterization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2007
Longer than P75 for all trials
1 active site
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
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
April 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 5, 2013
April 1, 2013
5.6 years
April 15, 2010
April 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pattern of inflammatory biomarkers
1 year
Secondary Outcomes (5)
Pattern of cell surface markers
1 year
Functional polymorphisms
1 year
Psychometric tests
1 year
Demographic tests
1 year
Severity of pain
1 year
Study Arms (1)
A
Patients with somatoform disorders due to DSM-IV
Eligibility Criteria
chronic pain patients with a somatoform disorder due to DSM-IV
You may qualify if:
- chronic pain patients with a somatoform disorder due to DSM-IV
- chronic pain \> 6 months in several anatomical regions
- presence of physical symptoms that suggest a general medical condition
- the symptoms must cause clinically significant distress or impairment in social, occupational, or other areas of functioning
- the physical symptoms are not under voluntary control
- Psychic factors exclusively or in combination with a medical disease factor influence onset, severity, exacerbation or maintenance of symptoms decisively
- fibromyalgia
You may not qualify if:
- age \< 18 years
- psychosis
- symptoms fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Ulmlead
- University Hospital Ulmcollaborator
Study Sites (1)
Clinic of Anesthesiology, Dept. of Pain
Ulm, 89070, Germany
Related Publications (1)
Schneider EM, Ma X, Stratz T, Muller W, Lorenz I, Seeling WD. Immunomodulatory function of the 5-HT3 receptor antagonist tropisetron. Scand J Rheumatol Suppl. 2004;119:34-40.
PMID: 15515411BACKGROUND
Biospecimen
Whole blood, serum, and white cells will be retained.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Steffen, MD
Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, MBA
Study Record Dates
First Submitted
April 15, 2010
First Posted
April 19, 2010
Study Start
August 1, 2007
Primary Completion
March 1, 2013
Study Completion
April 1, 2013
Last Updated
April 5, 2013
Record last verified: 2013-04