Immune Patterns in Pain Patients DSM-IV

Depression Clinical Trial

— IPPPDIV  

Official title:

Phase 1 Study of Immune, Psychometric and Sociodemographic Patterns in Pain Patients Classified by DSM-IV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106339
• Other study ID #: Anae_Pain_Ulm_DSM-IV
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: April 3, 2013
• Start date: August 2007
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Description:

Pain patients are defined as patients with a somatoform disorder due to DSM-IV, if chronic pain lasts for at least 6 months in several anatomical regions. Somatoform disorders (DSM-IV) have the presence of physical symptoms that suggest a general medical condition but that are not fully explained by a general medical condition, by the direct effects of a substance, or by another mental disorder. 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. A subgroup of somatoform disorders, i.e., fibromyalgia, is a common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, headaches, and occasionally depression. There is significant overlap between fibromyalgia and the chronic fatigue syndrome. Fibromyalgia may arise as a primary or secondary disease process. Interleukins IL-1ß, IL-6 und tumor necrosis factor-a have been detected in the skin of these patients. Blockade of the 5HT3 receptor has been reported to alleviate chronic pain in tendopathy, fibromyalgia and autoimmune diseases. However, only a subgroup of patients responds to this therapy. It is supposed that patients with somatoform disorders (DSM-IV) diagnosed according to clinical criteria consist of immunologically heterogenous groups. However, up to now, the immunologic and genetic background of patients with somatoform disorders classified via DSM-IV has not been systematically evaluated. The study concentrates on the psychometric characterization of patients with pain disorder focusing on depression, anxiety, coping behavior, psychic trauma, alexithymia and somatoform symptoms. The present study is performed to define subgroups of patients with somatoform disorders (DSM-IV) by immunological, pyschologic and genetic characterization which may benefit from potential 5HT3 receptor antagonists or anti-inflammatory therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• inclusion in other studies

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Depression
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Myofascial Pain Syndrome, Diffuse
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Locations

Country	Name	City	State
Germany	Clinic of Anesthesiology, Dept. of Pain	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	University Hospital Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schneider EM, Ma X, Stratz T, Müller W, Lorenz I, Seeling WD. Immunomodulatory function of the 5-HT3 receptor antagonist tropisetron. Scand J Rheumatol Suppl. 2004;119:34-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of inflammatory biomarkers		1 year	No
Secondary	Pattern of cell surface markers		1 year	No
Secondary	Functional polymorphisms		1 year	No
Secondary	Psychometric tests		1 year	No
Secondary	Demographic tests		1 year	No
Secondary	Severity of pain		1 year	No