Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders|
- Adequate Relief in Pain Score During Treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2008|
|Study Completion Date:||May 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Quetiapine treatment group
All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention.
Drug: Quetiapine (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)
Other Name: Seroquel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617396
|United States, North Carolina|
|UNC Center for Functional GI & Motility Disorders|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Douglas A Drossman, MD||UNC Chapel Hill|