An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adequate Relief in Pain Score During Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Quetiapine treatment group
All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention.
干预措施: Quetiapine (50 mg/day-100mg/day) (Drug)
结局指标
主要结局
Adequate Relief in Pain Score During Treatment
时间窗: 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.
次要结局
未报告次要终点