Open Label Seroquel Study for TR IBS

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

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.

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.

Intervention(s) in this Clinical Trial

• Drug: quetiapine
  • Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: a

Primary Measures

• Treatment response to both binary and ordinal measures determine efficacy of Seroquel in treating refractory and treatment resistant functional bowel disorders. Specifically, daily, weekly and monthly responder status will be evaluated.
  • Time Frame: 3 years
    Safety Issue?: Yes

Secondary Measures

• Repeated measures analysis using mixed effects models of primary outcomes of relief will be conducted to look for individual patient trajectories as they relate to dosage of Seroquel.
  • Time Frame: 3 years
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Douglas A Drossman, MD Other

Overall Clinical Trial Officials and Contacts

Douglas A Drossman, MD Principal Investigator UNC Chapel Hill  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00617396

Study ID Number: IRUSQUET0448

ClinicalTrials.gov Identifier: NCT00617396

Health Authority: United States: Food and Drug Administration