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Trial record 33 of 452 for:    QUETIAPINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00617396
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : March 21, 2014
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE February 5, 2008
First Posted Date  ICMJE February 18, 2008
Results First Submitted Date  ICMJE July 12, 2013
Results First Posted Date  ICMJE March 21, 2014
Last Update Posted Date September 15, 2017
Study Start Date  ICMJE February 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2008)
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 ]
Change History Complete list of historical versions of study NCT00617396 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
Official Title  ICMJE An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Functional Bowel Disorders
Intervention  ICMJE 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 Name: Seroquel
Study Arms  ICMJE Experimental: Quetiapine treatment group
All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention.
Intervention: Drug: Quetiapine (50 mg/day-100mg/day)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2008)
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00617396
Other Study ID Numbers  ICMJE IRUSQUET0448
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Douglas A Drossman, MD UNC Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP