Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
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|ClinicalTrials.gov Identifier: NCT00617396|
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : March 21, 2014
Last Update Posted : September 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Functional Bowel Disorders||Drug: Quetiapine (50 mg/day-100mg/day)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||May 2012|
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
- Adequate Relief in Pain Score During Treatment [ Time Frame: 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|