Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders

Conditions
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Functional Bowel Disorders

Intervention / Treatment
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* Drug: Quetiapine (50 mg/day-100mg/day)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quetiapine treatment group<br>All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention. | Drug: Quetiapine (50 mg/day-100mg/day)<br>* Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)<br>* Other names: Seroquel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Seroquel, Abdominal Pain