Open Label Seroquel Study for TR IBS
Recruitment status was Active, not recruiting
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:||Allocation: Non-Randomized
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|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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.
|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|