Open Label Seroquel Study for TR IBS - Full Text View

Sponsor:	Douglas A Drossman, MD
Collaborator:	AstraZeneca
Information provided by (Responsible Party):	Douglas A Drossman, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00617396

Purpose

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	Intervention
Functional Bowel Disorders	Drug: quetiapine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders

Resource links provided by NLM:

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Treatment response to both binary and ordinal measures determine efficacy of Seroquel in treating refractory and treatment resistant functional bowel disorders. Specifically, daily, weekly and monthly responder status will be evaluated. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Repeated measures analysis using mixed effects models of primary outcomes of relief will be conducted to look for individual patient trajectories as they relate to dosage of Seroquel. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: a	Drug: quetiapine 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617396

Locations

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

Sponsors and Collaborators

Douglas A Drossman, MD

AstraZeneca

Investigators

Principal Investigator:

Douglas A Drossman, MD

UNC Chapel Hill

More Information

No publications provided

Responsible Party:	Douglas A Drossman, MD, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00617396 History of Changes
Other Study ID Numbers:	IRUSQUET0448
Study First Received:	February 5, 2008
Last Updated:	December 6, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

Irritable Bowel Syndrome
Seroquel
Abdominal Pain

Additional relevant MeSH terms:

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Quetiapine
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012