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

Primary Purpose

Functional Bowel Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quetiapine (50 mg/day-100mg/day)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Bowel Disorders focused on measuring Irritable Bowel Syndrome, Seroquel, Abdominal Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Center for Functional GI & Motility Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quetiapine treatment group

Arm Description

All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention.

Outcomes

Primary Outcome Measures

Adequate Relief in Pain Score During Treatment
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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2008
Last Updated
September 13, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00617396
Brief Title
Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
Official Title
An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Bowel Disorders
Keywords
Irritable Bowel Syndrome, Seroquel, Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine treatment group
Arm Type
Experimental
Arm Description
All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention.
Intervention Type
Drug
Intervention Name(s)
Quetiapine (50 mg/day-100mg/day)
Other Intervention Name(s)
Seroquel
Intervention Description
Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)
Primary Outcome Measure Information:
Title
Adequate Relief in Pain Score During Treatment
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas A Drossman, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Center for Functional GI & Motility Disorders
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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

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