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

NCT00617396 | Completed Results

• 1 other identifier: IRUSQUET0448
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Bowel Disorders

Keywords

Irritable Bowel Syndrome; Seroquel; Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Quetiapine treatment group

EXPERIMENTAL

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

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

Interventions

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)

Also known as: Seroquel

Quetiapine treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• AstraZeneca: collaborator

Study Sites (1)

UNC Center for Functional GI & Motility Disorders

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

1. Uncontrolled open label study and is vulnerable to biases favoring a treatment response. 2. Sample size is small.

Results Point of Contact

• Title: Dr. Douglas Drossman
• Organization: UNC Chapel Hill

douglas_drossman@med.unc.edu

919-966-0141

Study Officials

• Douglas A Drossman, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 18, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 15, 2017
• Results First Posted: March 21, 2014

Record last verified: 2014-02

Locations

US (1)