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

An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders

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 Overview

• Status: Completed
• Conditions: Functional Bowel Disorders
• Intervention / Treatment: Drug: Quetiapine (50 mg/day-100mg/day)

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Center for Functional GI & Motility Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Seroquel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Douglas A Drossman, MD, UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 5, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Abdominal Pain; Seroquel
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: IRUSQUET0448