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

NCT ID: NCT00617396

Last Updated: 2017-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-05-31

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.

Conditions

Functional Bowel Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quetiapine treatment group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Seroquel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas A Drossman, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

UNC Center for Functional GI & Motility Disorders

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

IRUSQUET0448

Identifier Type: -

Identifier Source: org_study_id