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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Douglas A Drossman, MD; University of North Carolina, Chapel Hill
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

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