Irritable Bowel SyndromeNCT00880594
Irritable Bowel Syndrome (IBS) Functional Magnetic Resonance Imaging (fMRI) With Desipramine
A study testing Desipramine in people with Irritable Bowel Syndrome, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Desipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to 11 Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- Analgesics (narcotics, NSAIDs; acetaminophen OK)
- Muscle relaxants
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: The Modulation of Cerebral Pain Responses Using Desipramine in the Treatment of Irritable Bowel Syndrome (IBS)
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.
Read the detailed description
Background Irritable bowel syndrome (IBS) is a common abdominal pain disorder diagnosed by symptom-based criteria (Rome III). Since there is no objective measure available to establish a formal diagnosis, IBS likely encompasses a biologically heterogeneous group of patients with distinct pathophysiology. To date, studies evaluating the mechanistic basis of IBS largely have focused on bowel-specific factors. More recently, differences in brain activation patterns in response to painful visceral stimuli (rectal balloon distention) have been identified in IBS subjects compared to healthy controls. These differences often are observed within the homeostatic afferent processing network (HAPN), regions of the brain responsible for the descending inhibition of pain signals, as well as the affective and emotional response to pain. However, IBS brain activation patterns are inconsistent across IBS studies. One likely explanation for this variation in brain activations is the role of psychiatric co-morbidity often present in IBS. No study to-date has considered whether unique patterns of cerebral activation during visceral stimulation exist among subgroups of IBS patients. In our current work, we are exploring the role of multiple co-morbid unexplained pain syndromes, hereafter referred to as 'somatization', and its relevance to IBS subjects' brain responses to pain. We anticipate that IBS patients with somatization (IBS-S+) have aberrant descending inhibitory neurocircuitry, facilitating more intense pain experiences across a spectrum of ascending pain signals (both visceral and somatic). Somatization can be readily detected using standardized instruments and medical histories, and when present in IBS subjects clinically portends more severe bowel symptoms, and poorer responses to proven bowel-specific IBS therapies. Greater insight into the relevance of somatization and mood symptoms to HAPN brain networks thus is not only critical to our understanding of the pathophysiology of IBS, but also may reveal additional clinical targets for the management of these disorders.
Hypotheses and Aims The overarching hypothesis of this proposal is that abnormal homeostatic afferent processing network (HAPN) responses to visceral stimulation have mechanistic relevance to a subset of patients with IBS. It is further hypothesized that abnormalities HAPN responses to afferent pain signals in IBS subjects with comorbid somatization (IBS-S+) result in: (1) more generalized pain experiences (both visceral and somatic), and (2) more severe IBS and somatic pain symptom experiences.
Using functional magnetic resonance imaging (fMRI), our preliminary findings have revealed abnormal activation of HAPN brain regions following visceral stimulation in IBS subjects compared to healthy controls. Our pilot data also demonstrated a distinct pattern of abnormal HAPN activations in response to visceral stimulation in IBS subjects with comorbid somatization (IBS-S+) compared to those without somatization (IBS-S-). These findings suggest that clinical differences between IBS-S+ and IBS-S- subjects may result from aberrant HAPN responses to visceral sensory input. The purpose of this proposal is to further investigate the mechanistic importance of the brain's homeostatic afferent processing network in the presence of overlapping somatization and mood disorders to symptom experiences in IBS.
This goal will be realized through the pursuit of the following Specific Aims:
Specific Aim 1. To validate homeostatic afferent processing network (HAPN) activation patterns with noxious visceral stimulation in IBS subjects, and determine their relationship to visceral pain symptom experiences.
Hypothesis 1: IBS subjects collectively will demonstrate a pattern of abnormal HAPN activation in response to noxious visceral stimulation Hypothesis 1b: Abnormal HAPN brain activations overall will correlate with greater subjective pain ratings of noxious visceral stimulation in IBS subjects Specific Aim 2. To evaluate the influence of somatization on HAPN activations with noxious visceral and somatic stimulation in IBS subjects, and determine their relationship to pain symptom experiences.
Hypothesis 2: IBS subjects with comorbid somatization (IBS-S+) will demonstrate abnormal HAPN activation in response to both noxious visceral and somatic stimuli, when compared to IBS subjects with no somatization (IBS-S-).
Specific Aim 3: To determine the influence of despiramine on abnormal HAPN brain activations in IBS-S+ and IBS-S- subjects.
Hypothesis 3: Desipramine will normalize HAPN activations in both IBS-S+ and IBS-S-, with greater effects in the IBS-S+ cohort.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Desipramine
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesipramineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| IBS-High somatization | Experimental | Participants meeting Rome III criteria for IBS and with high somatization (PHQ≥10) Receives: Drug: Desipramine |
| IBS-Low somatization | Experimental | Participants meeting Rome III criteria for IBS and with high somatization (PHQ≤5) Receives: Drug: Desipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completion11 Nov 2014
- Study completion11 Nov 2014
Why it stopped: Due to changes in trial personnel (co-investigator and research coordinator leaving the institution).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory S. Sayuk, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880594
- Sponsor's protocol ID
- 09-0013
- Status last verified
- Jan 2026
- First submitted
- 13 Apr 2009
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modulation of Cerebral Pain Responses Using Desipramine in the Treatment of Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT00880594
- Acronym / sponsor ID
- 09-0013
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to changes in trial personnel (co-investigator and research coordinator leaving the institution).
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- 11 Nov 2014 (actual)
- Study completion
- 11 Nov 2014 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Irritable bowel syndrome (IBS) is a common abdominal pain disorder diagnosed by symptom-based criteria (Rome III). Since there is no objective measure available to establish a formal diagnosis, IBS likely encompasses a biologically heterogeneous group of patients with distinct pathophysiology. To date, studies evaluating the mechanistic basis of IBS largely have focused on bowel-specific factors. More recently, differences in brain activation patterns in response to painful visceral stimuli (rectal balloon distention) have been identified in IBS subjects compared to healthy controls. These differences often are observed within the homeostatic afferent processing network (HAPN), regions of the brain responsible for the descending inhibition of pain signals, as well as the affective and emotional response to pain. However, IBS brain activation patterns are inconsistent across IBS studies. One likely explanation for this variation in brain activations is the role of psychiatric co-morbidity often present in IBS. No study to-date has considered whether unique patterns of cerebral activation during visceral stimulation exist among subgroups of IBS patients. In our current work, we are exploring the role of multiple co-morbid unexplained pain syndromes, hereafter referred to as 'somatization', and its relevance to IBS subjects' brain responses to pain. We anticipate that IBS patients with somatization (IBS-S+) have aberrant descending inhibitory neurocircuitry, facilitating more intense pain experiences across a spectrum of ascending pain signals (both visceral and somatic). Somatization can be readily detected using standardized instruments and medical histories, and when present in IBS subjects clinically portends more severe bowel symptoms, and poorer responses to proven bowel-specific IBS therapies. Greater insight into the relevance of somatization and mood symptoms to HAPN brain networks thus is not only critical to our understanding of the pathophysiology of IBS, but also may reveal additional clinical targets for the management of these disorders.
Hypotheses and Aims The overarching hypothesis of this proposal is that abnormal homeostatic afferent processing network (HAPN) responses to visceral stimulation have mechanistic relevance to a subset of patients with IBS. It is further hypothesized that abnormalities HAPN responses to afferent pain signals in IBS subjects with comorbid somatization (IBS-S+) result in: (1) more generalized pain experiences (both visceral and somatic), and (2) more severe IBS and somatic pain symptom experiences.
Using functional magnetic resonance imaging (fMRI), our preliminary findings have revealed abnormal activation of HAPN brain regions following visceral stimulation in IBS subjects compared to healthy controls. Our pilot data also demonstrated a distinct pattern of abnormal HAPN activations in response to visceral stimulation in IBS subjects with comorbid somatization (IBS-S+) compared to those without somatization (IBS-S-). These findings suggest that clinical differences between IBS-S+ and IBS-S- subjects may result from aberrant HAPN responses to visceral sensory input. The purpose of this proposal is to further investigate the mechanistic importance of the brain's homeostatic afferent processing network in the presence of overlapping somatization and mood disorders to symptom experiences in IBS.
This goal will be realized through the pursuit of the following Specific Aims:
Specific Aim 1. To validate homeostatic afferent processing network (HAPN) activation patterns with noxious visceral stimulation in IBS subjects, and determine their relationship to visceral pain symptom experiences.
Hypothesis 1: IBS subjects collectively will demonstrate a pattern of abnormal HAPN activation in response to noxious visceral stimulation Hypothesis 1b: Abnormal HAPN brain activations overall will correlate with greater subjective pain ratings of noxious visceral stimulation in IBS subjects Specific Aim 2. To evaluate the influence of somatization on HAPN activations with noxious visceral and somatic stimulation in IBS subjects, and determine their relationship to pain symptom experiences.
Hypothesis 2: IBS subjects with comorbid somatization (IBS-S+) will demonstrate abnormal HAPN activation in response to both noxious visceral and somatic stimuli, when compared to IBS subjects with no somatization (IBS-S-).
Specific Aim 3: To determine the influence of despiramine on abnormal HAPN brain activations in IBS-S+ and IBS-S- subjects.
Hypothesis 3: Desipramine will normalize HAPN activations in both IBS-S+ and IBS-S-, with greater effects in the IBS-S+ cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS-High somatization | Experimental | Drug: DesipramineParticipants meeting Rome III criteria for IBS and with high somatization (PHQ≥10) |
| IBS-Low somatization | Experimental | Drug: DesipramineParticipants meeting Rome III criteria for IBS and with high somatization (PHQ≤5) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesipramineDesipramine 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. | Drug | IBS-High somatization, IBS-Low somatization |
Primary outcome
MRI Blood Oxygen Level Dependent (BOLD) Activation CONTRASTS (in Prespecified Regions of Interest (ROI) in VOXELS
Time frame: 1 month
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".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory S. Sayuk, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desipramine in people with Irritable Bowel Syndrome, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Blood Oxygen Level Dependent (BOLD) Activation CONTRASTS (in Prespecified Regions of Interest (ROI) in VOXELS (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.