Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Douglas A Drossman, MD University of North Carolina, Chapel Hill