Escitalopram Trial for Irritable Bowel Syndrome (IBS) Patients With Panic Disorder

Study Overview
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Brief Summary
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This study will be executed according to a randomized double-blind placebo-controlled trial with two parallel groups, treated over the period of 6 months with escitalopram or placebo. Hypotheses: Escitalopram is more effective than placebo in the control of gastrointestinal symptoms, in irritable bowel syndrome (IBS) patients with panic disorder. Escitalopram is more effective than placebo in the control of psychiatric symptoms, in IBS patients with panic disorder.

Official Title
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Randomized Controlled Trial of Escitalopram Versus Placebo for Patients With Irritable Bowel Syndrome and Panic Disorder

Conditions
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Irritable Bowel Syndrome, Panic Disorder

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IBS will be diagnosed according to the Rome III criteria by a gastroenterologist. Subtyping of IBS patients will be performed using the following classification according to the Rome III criteria: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M) or not subtyped IBS (IBS-U). Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined. A panic disorder will be diagnosed based on DSM IV criteria by a psychiatrist. Age above 18 years and under 70 years. Given written informed consent. Exclusion Criteria: Inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, duspatalin, metoclopramide, domperidon, erytromycin), serotonin metabolism (like carbidopa, food supplementation), or epigenetics (like valproic acid), or containing perforated St. John's wort (Hypericum perforatum). In general this medication can be stopped without problems. However, this can increase symptoms. When the increase in symptoms will be to high, this medication will be restarted and the patient excluded form the study. Administration of investigational drugs in the 180 days prior to the study. 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. Pregnancy and lactation. Excessive alcohol consumption (> 20 alcoholic consumptions per week) or drug abuse. Co-intervention or other treatment for IBS or anxiety, with the exception of initial co-intervention with benzodiazepines (alprazolam) contrasting side effects due to SSRI's during the first two weeks of dose elevation. Known prolongation of QT-interval or long-QT-syndrome, other cardiac disease, or use of medication with known prolongation of QT-interval.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Escitalopram<br>17 or 18 Patients with IBS and panic disorder treated with Escitalopram. | Drug: Escitalopram<br>* Patients will start at a dosage of 5 mg daily of escitalopram. After the first week of treatment the dosage will be increased to 10 mg daily. During the visits, the dosage can be gradually increased to a maximum of 20 mg daily, depending on the response of the patient.<br>* Other names: Lexapro;|
| Placebo Comparator: Placebo tablets to Escitalopram<br>17 or 18 Patients with IBS and panic disorder treated with placebo. | Drug: Escitalopram<br>* Patients will start at a dosage of 5 mg daily of escitalopram. After the first week of treatment the dosage will be increased to 10 mg daily. During the visits, the dosage can be gradually increased to a maximum of 20 mg daily, depending on the response of the patient.<br>* Other names: Lexapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptom Rating Scale (GSRS). | Gastrointestinal Symptom Rating Scale (GSRS) is a self-assessment questionnaire for gastrointestinal symptoms. | Change from baseline in outcome of GSRS at 6 months. | 
| State Trait Anxiety Inventory (STAI). | State Trait Anxiety Inventory (STAI) is a self-assessment device, which includes separate measures of state and trait anxiety. | Change from baseline in outcome of STAI at 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Escitalopram, Irritable bowel syndrome, Panic disorder