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

NCT00880594 | Terminated Results

• 1 other identifier: 09-0013
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• MRI Blood Oxygen Level Dependent (BOLD) Activation CONTRASTS (in Prespecified Regions of Interest (ROI) in VOXELS

  CONTRASTS (comparisons of study group BOLD activations vs rest) are the outcome of interest. Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions. First level analyses of rectal balloon distensions experienced by subjects were modeled as box car functions then convolved with the canonical hemodynamic response function (HRF). For the second level analyses, differences in brain activation while experiencing both high and low painful rectal balloon distensions between IBS patients with High somatization vs Low somatization were examined with two-sample t-tests utilizing contrast images generated from the first level analysis. Unconventionally, these inferential statistics are regarded as the primary outcome in the study. Accordingly individual group level BOLD values where not recorded or evaluated separately in the cohorts. These data are not available, and cannot be reported "per Arm".

  1 month

Study Arms (2)

IBS-High somatization

EXPERIMENTAL

Participants meeting Rome III criteria for IBS and with high somatization (PHQ≥10)

Drug: Desipramine

IBS-Low somatization

EXPERIMENTAL

Participants meeting Rome III criteria for IBS and with high somatization (PHQ≤5)

Drug: Desipramine

Interventions

Desipramine DRUG

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.

IBS-High somatization; IBS-Low somatization

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Persons are excluded from participation for having various psychiatric, medical, and other characteristics.
• Analgesics (narcotics, NSAIDs; acetaminophen OK)
• Muscle relaxants
• Psychoactive agents (antidepressants, antipsychotics)
• Other medications (phenytoin; amphetamines, prescription weight-loss drugs, or benzodiazepines)
• Thyroid medication
• Anticholinergic medications or other IBS medications (hyoscyamine, dicyclomine)
• Cytochrome p450 substrates
• Participation in any clinical trial using any other drug.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Desipramine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Desipramine open-label completion target not achieved

Results Point of Contact

• Title: Gregory Sayuk
• Organization: Washington University School of Medicine

gsayuk@wustl.edu

314-454-8201

Study Officials

• Gregory S. Sayuk, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 14, 2009
• Study Start: February 1, 2009
• Primary Completion: November 11, 2014
• Study Completion: November 11, 2014
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Locations

US (1)