Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients: An Open-label, Randomized, add-on Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- HDRS-17
研究概览
简要总结
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine Controlled Release (CR) in patients with Major Depressive Disorder (MDD) comorbid Irritable Bowel Syndrome (IBS).
Subjects will be patients who are referred to the outpatient or inpatient clinic of gastroenterology departments of province level general hospitals in China. All subjects present with irritable bowel syndrome according to ROME III, and also are diagnosed with MDD by Mini-International Neuropsychiatric Interview (MINI). All subjects will provide written informed consent prior to participating in the study. Subjects will be assessed for eligibility at a screening visit, with eligible patients returning for a assessment within 1 week, at which time they will randomly enter into paroxetine CR (12.5mg/d, flexible dose: 12.5-50mg/d) plus IBS regular treatment or IBS regular treatment only. Subjects will be evaluated at weeks 2 (Day 14), 4 (Day 28), 6 (Day 42) and 8 (Day 56), for a total of 5 study treatment visits.
详细描述
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine CR in patients with MDD comorbid IBS.
This study is designed with a 1-week screening period, followed by 8 weeks of treatment and 1 week follow up period, 7 visits totally; the calculation of visit date is base on the real date of random date.
Study Screening:
Visit 1: a screening period for within 7 days to determine eligibility for the study, subjects aged ≥ 18 and ≤ 65 years at the time of screening, must have a diagnosis of IBS and MDD. After giving their informed consent to participate in the study, patients will undergo screening assessments, including demographic data (birth, race, gender, height, weight), medical history, disease history, therapy history, concomitant medication, physical examination, vital signs, 12-lead ECG and laboratory assessments.
Treatment Phase:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic for IBS according to ROME III;
- •Meet the diagnostic for MDD according to MINI;
- •Age≥18 and ≤ 65;
- •Patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation; processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
排除标准
- •Patients were also excluded if they had any medical condition that would contraindicate the use of paroxetine CR [Seroxat CR®];
- •History of alcohol / drug dependence and schizophrenia; history of serious mental illness;
- •Major neurological deficits that interfere with the patient's ability to understand the study procedures and provide a written informed consent;
- •Patients were also excluded if their current episode of depression had failed to respond to two or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks;
- •Suicide ideation;
- •Use monoamine oxidase inhibitors (MAOIs), benzodiazepines or other antidepressants within at least 14 days before study begin;
- •Other medical and psychological conditions prevent patients from participating in the study or signing informed consent;
- •Pregnant or lactating females, or anyone who plan to become pregnant during the study period;
- •Those who are known to currently participate a clinical trial;
- •Those patients with significant organ disease. GI disorders that are infectious;
- •Ischemic, radiation-induced, or medication-induced; inflammatory bowel disease (Cohn's disease and ulcerative colitis);
- •Recent gastrointestinal surgery (within 6 months).
- •Has received electroconvulsive therapy (ECT) or psychotherapy in the 3 months prior to screening.
- •Presents with clinically significant abnormalities in haematology, clinical chemistry, electrocardiogram (ECG) or physical examination at screening which have not resolved prior to the baseline visit or has clinically significant conditions, which in the opinion of the investigator, will render the patient unsuitable for the study and pose a safety concern or interfere with the accurate safety and efficacy assessments (e.g., severe cardiovascular disease, hepatic or renal failure etc).
研究组 & 干预措施
Paroxetine CR group
Paroxetine CR plus IBS regular treatment group
干预措施: Paroxetine CR (Drug)
结局指标
主要结局
HDRS-17
时间窗: 8 weeks
次要结局
- HDRS-17 item 10(8 weeks)
- CGI-I(8 weeks)
- CGI-S(8 weeks)
- WHOQOL(8 weeks)
- IBSSS(8 weeks)