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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT00617396
• Collaborator: AstraZeneca (Industry)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 51
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Bowel Disorders	Drug: Quetiapine (50 mg/day-100mg/day)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adequate Relief in Pain Score During Treatment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UNC Center for Functional GI & Motility Disorders	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• AstraZeneca

Investigators

• Principal Investigator: Douglas A Drossman, MD, UNC Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT00617396
• Other Study ID Numbers: IRUSQUET0448
• First Posted: Feb 18, 2008
• Last Update Posted: Sep 15, 2017
• Last Verified: Feb 1, 2014

• Keywords provided by University of North Carolina, Chapel Hill: Irritable Bowel Syndrome; Seroquel; Abdominal Pain
• Additional relevant MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Quetiapine Fumarate

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from UNC GI outpatient clinic. Other recruitment strategies like newspaper ads, UNC mass emails and flyers were used. Recruitment started around 12/2007.
Pre-assignment Detail	This was 13 week long study which included 1 week of screning period followed by 4 weeks of treatment phase and 4 weeks of follow up period. During the screening visit following procedures were done- informed consent,medical history and demographics collection Vitals including abdominal girth,physical examination baseline labs and questionnaires

Arm/Group Title	Quetiapine ( 50mg/Day -100mg/Day)
Arm/Group Description	There is only one group. All Subjects begin with a dose quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. 25 subjects were enrolled in this group.
Period Title: Overall Study
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Quetiapine ( 50mg/Day -100mg/Day)
Arm/Group Description	There is only one group. All Subjects begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total) 25 subjects were enrolled in this group.
Overall Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.8 (14.5)
Sex: Female, Male (Count of Participants)
Female	25 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	Adequate Relief in Pain Score During Treatment
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

There was no exact statistical test used to determine the sample size. It is based on the capacity of site to recruit subjects.

Arm/Group Title	Quetiapine ( 50mg/Day -100mg/Day)
Arm/Group Description	There is only one group. All Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)30 subjects were enrolled in this group.
Measure Participants	25
Number [percentage of subjects]	52.6 (2.0)

Adverse Events

Time Frame	3 years
Arm/Group Title	Quetiapine ( 50mg/Day -100mg/Day)
Arm/Group Description	There is only one group. All Subject begin with a dose Quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)29 subjects were enrolled in this group.
All Cause Mortality
	Quetiapine ( 50mg/Day -100mg/Day)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Quetiapine ( 50mg/Day -100mg/Day)
	Affected / at Risk (%)	# Events
Total	1/25 (4%)
Nervous system disorders
cerebrovascular accident	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	Quetiapine ( 50mg/Day -100mg/Day)
	Affected / at Risk (%)	# Events
Total	23/25 (92%)
Gastrointestinal disorders
worsening abdominal pain or discomfort	4/25 (16%)	4
Musculoskeletal and connective tissue disorders
tiredness	17/25 (68%)	17
Nervous system disorders
Drowsiness	23/25 (92%)	23

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.