Functional Bowel Disorders
Conditions
Keywords
Irritable Bowel Syndrome, Seroquel, Abdominal Pain
Brief summary
Purpose: We are proposing to examine, via open label trial, the use of Seroquel® for patients with moderate to severe functional bowel symptoms who are not receiving adequate relief from their symptoms on their present regimen of SNRI or TCA antidepressant agents. Participants: Primary eligibility will be determined of patients at The UNC Center for Functional GI & Motility Disorders Clinic who score in the moderate to severe range on the Functional Bowel Disorders Severity Index (FBDSI ≥ 37) who have failed or have incomplete treatment responses of medications including at least one prior trial of antidepressant medication. Procedures (methods): We will monitor several patient and symptom related outcomes, as well as evaluate health related quality of life, psychological distress and related psychosocial measures to determine if the addition of Seroquel® over and above the use of an antidepressant improves clinical response based on an adequate relief measure as well as selected secondary outcomes. We will also determine when treatment benefit is related to effects on pain, the associated psychological co-morbidities seen in this population, or both factors.
Detailed description
The UNC Center for Functional GI & Motility Disorders Clinic frequently receives referrals for patients with chronic and treatment refractory symptoms of abdominal pain and bowel dysfunction. Many of these patients are diagnosed with irritable bowel syndrome, painful functional constipation or functional abdominal pain syndrome using Rome III criteria. The presenting symptoms of the referral population are frequently in the severe range, with patients having intensely painful symptoms, Axis I and Axis II co-morbidities, and impaired health related quality of life. Failure of multiple standard treatment attempts prior to referral is customary for patients seen in our clinic. Additionally, a greater number of patients only experience a partial response to standard treatment. We are therefore attempting to address these patients utilizing novel treatment strategies such as we propose here.
Interventions
DRUGQuetiapine (50 mg/day-100mg/day)
Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)
Sponsors
AstraZeneca
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* The subject has been diagnosed with a painful functional bowel disorder lasting longer than six months * The subject achieves a score greater than 37 on the Functional Bowel Disorders Severity Index * Four weeks on anti-depressant medications did not lead to adequate relief of the GI symptoms
Exclusion criteria
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others * Known intolerance or lack of response to Seroquel as judged by the investigator * Use of prohibited medicationsMedical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment * Unstable or inadequately treated medical * An absolute neutrophil count (ANC) of ≤1.5 X 109 per liter * Subject is pregnant or breastfeeding. * Subject is taking other medication thought to directly affect gut function via the 5HT method of action (Tegaserod) * Known hypersensitivity to duloxetine or any of the inactive ingredients in duloxetine * Any patient taking Monoamine Oxidase Inhibitors * Patient with uncontrolled narrow-angle glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Relief in Pain Score During Treatment | 8 weeks | Biweekly relief in pain Biweekly subjects were asked whether they had adequate relief of pain. It was binary questionnaire i.e.- Did you have adequate relief of pain in last two weeks? 1) yes 2) no The measure is percentage of subjects who said yes who had adequate relief of pain. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from UNC GI outpatient clinic. Other recruitment strategies like newspaper ads, UNC mass emails and flyers were used. Recruitment started around 12/2007.
Pre-assignment details
This was 13 week long study which included 1 week of screning period followed by 4 weeks of treatment phase and 4 weeks of follow up period. During the screening visit following procedures were done- informed consent,medical history and demographics collection Vitals including abdominal girth,physical examination baseline labs and questionnaires
Participants by arm
| Arm | Count |
|---|---|
| Quetiapine ( 50mg/Day -100mg/Day) There is only one group. All Subjects begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total) 25 subjects were enrolled in this group. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Quetiapine ( 50mg/Day -100mg/Day) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 38.8 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Adequate Relief in Pain Score During Treatment
Biweekly relief in pain Biweekly subjects were asked whether they had adequate relief of pain. It was binary questionnaire i.e.- Did you have adequate relief of pain in last two weeks? 1) yes 2) no The measure is percentage of subjects who said yes who had adequate relief of pain.
Time frame: 8 weeks
Population: There was no exact statistical test used to determine the sample size. It is based on the capacity of site to recruit subjects.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Quetiapine ( 50mg/Day -100mg/Day) | Adequate Relief in Pain Score During Treatment | 52.6 percentage of subjects | 2 |