Randomized controlled trial of escitalopram versus placebo for patients with irritable bowel syndrome and panic disorder. - escitalopram trial

MUMC0 个研究点目标入组 80 人开始时间: 2010年6月17日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•IBS will be diagnosed according to the Rome III criteria1 *:
•Recurrent abdominal pain or discomfort at least 3 days per month in the last 3
•months associated with 2 or more of the following:
•Improvement with defecation.
•Onset associated with a change in frequency of stool.
•Onset associated with a change in form (appearance) of stool.
•*Criteria have to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
•*Discomfort means an uncomfortable sensation not described as pain. In pathophysiological research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation is an indication for subject’s eligibility.
•2) Subtyping of IBS patients will be performed using the following classification
•according tot the Rome III criteria: IBS with constipation (IBS-C), IBS
•with diarrhea (IBS-D), mixed IBS (IBS-M) or unsubtyped IBS (IBS-U).
•3) Based on the medical history and previous examination, no other causes for the
•abdominal complaints can be defined.
•4) A panic disorder will be diagnosed based on DSM IV criteria.
•5) Age above 18 years and under 70 years.
•6) Given written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Inability to stop medication that can influence gastrointestinal motility or perception
•(like loperamide, butylscopolamine, duspatal, metoclopramide, domperidon,
•erytromycine), serotonin metabolism (like carbidopa, food supplementation), or
•epigenitics (like valproic acid), or containing Sint-Janskruid (Hypericum perforatum).
•2) Administration of investigational drugs in the 180 days prior to the study.
•3) Major abdominal surgery interfering with gastrointestinal function (uncomplicated
•appendectomy, cholecystectomy and hysterectomy allowed, and other surgery
•upon judgement of the principle investigator), epilepsy or (hypo)manic episodes.
•4) Pregnancy and lactation.
•5) Excessive alcohol consumption (>20 alcoholic consumption per week) or drug
•6) Co-intervention or other treatment for IBS or anxiety, with the exception of initial
•co-intervention with benzodiazepines (alprazolam) contrasting side effects due to
•SSRIs during the first two weeks of administration or during the first two weeks of
•dose elevation.
•7) Known prolongation of QT-interval or long-QT-syndrome, other cardiac disease,
•or use of medication with known prolongation of QT-interval.

发起方