Irritable Bowel Syndrome (IBS) Functional Magnetic Resonance Imaging (fMRI) With Desipramine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00880594
First received: April 13, 2009
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

Individuals with irritable bowel syndrome (IBS) may experience abdominal pain as a result of pain signals in the bowel and how these signals are processed in the brain. Studies using brain imaging (pictures) have shown that IBS patients with more pain diagnoses (i.e. fibromyalgia, migraines, etc.) have greater activity in the regions of the brain responsible for the emotional and thought processing of pain signals. This could possibly make bowel sensations and bowel difficulties feel abnormal or more noticeable, in turn causing more severe IBS symptoms. The purpose of this protocol is to explore the role of pain diagnoses and their affect on brain activity in IBS patients. The investigators will also examine the use of a medication, desipramine, which is known to affect these brain regions, in IBS patients.


Condition Intervention
Irritable Bowel Syndrome
Drug: Desipramine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Modulation of Cerebral Pain Responses Using Desipramine in the Treatment of Irritable Bowel Syndrome (IBS)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Changes in brain activations using functional MR following desipramine therapy in IBS populations. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Desipramine
    Desipramine 25 mg/day administered in the evening. Dosing may be increased dependent upon side-effects and clinical response to a maximum of 100 mg/day. Absent significant side-effects, all patients are increased at the one week visit to 50 mg/day at bedtime if they have not achieved a report of "Adequate relief". Thereafter, up to week 4, the daily desipramine dose may be increased weekly by 25 mg up to the 100 mg/d maximum.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • IBS subjects with- and without comorbid somatization features will be recruited from the sources highlighted above.
  • To be eligible, subjects will have to be between 18 and 90 years of age (inclusive) and qualify for a diagnosis of irritable bowel syndrome according to the criteria set forth in the Rome III criteria for the Diagnosis of Functional GI Disorders.
  • IBS patients will then be assessed in terms of comorbid somatization as determined using the Patient Health Questionnaire-15 (PHQ-15).
  • For this particular study, only subjects with high somatization (PHQ ≥ 10 or low somatization (PHQ ≤5) will be considered for enrollment.
  • Verification of somatization status will be performed using a formal structured interview process (Diagnostic Interview Schedule, DIS).
  • Persons are eligible to participate without regard to race or ethnicity.
  • Given sex differences in cerebral responses to noxious stimuli and the greater prevalence of IBS in women, only female participants will be sought in this study.
  • Also, in view brain hemispheric differences between left- and right-hand dominant individuals and the greater prevalence of right-handedness, all participants must be right-handed

Exclusion Criteria:

  • Persons are excluded from participation for having various psychiatric, medical, and other characteristics.
  • Psychiatric/cognitive exclusions include any of the following: active suicidal or homicidal ideation or a history of attempted suicide, current excessive alcohol use or other substance abuse disorders, active major depression, anxiety disorder, bipolar depression or any psychotic disorder, unwillingness to be randomized or provide informed consent, inability to communicate with staff or significant cognitive impairment.
  • Medical and other exclusions include any of the following: renal or hepatic disease or impairment, diabetes, cardiovascular disease, cardiac arrythmia, cerebrovascular disease, or breastfeeding, pregnant, or imminent intention of pregnancy, history of seizures or primary neurological disorder, head trauma, brain damage, hyper- or hypothyroidism, history or abdominal surgery (other than cholecystectomy/appendectomy), or known structural GI disorder (Crohn's disease, etc.), contraindication to MRI (metallic implant, pacemaker), or rectal balloon distention (e.g., proctitis/colitis).
  • Exclusions related to medications:

    1. Analgesics (narcotics, NSAIDs; acetaminophen OK)
    2. Muscle relaxants
    3. Psychoactive agents (antidepressants, antipsychotics)
    4. Other medications (phenytoin; amphetamines, prescription weight-loss drugs, or benzodiazepines)
    5. Thyroid medication
    6. Anticholinergic medications or other IBS medications (hyoscyamine, dicyclomine)
    7. Cytochrome p450 substrates
    8. Participation in any clinical trial using any other drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880594

Contacts
Contact: Darren Nix 314-362-3201 nixd@msnotes.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Darren Nix    314-362-3201    nixd@msnotes.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Gregory S. Sayuk, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Gregory S. Sayuk, M.D., Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00880594     History of Changes
Other Study ID Numbers: 09-0013
Study First Received: April 13, 2009
Last Updated: March 15, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Desipramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014