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.

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Key information

Conditions

Functional Bowel Disorders Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Center for Functional GI & Motility Disorders

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine (50 mg/day-100mg/day)

Drug

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

AstraZeneca

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Feb 18, 2008
Registry last updated: Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed