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

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.

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Key information

Conditions

Irritable Bowel Syndrome Anxiety Disorders Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Mental Disorders Panic Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

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.

Other names: Lexapro

Primary outcomes

Gastrointestinal Symptom Rating Scale (GSRS).

Time frame: Change from baseline in outcome of GSRS at 6 months.

Gastrointestinal Symptom Rating Scale (GSRS) is a self-assessment questionnaire for gastrointestinal symptoms.
State Trait Anxiety Inventory (STAI).

Time frame: Change from baseline in outcome of STAI at 6 months.

State Trait Anxiety Inventory (STAI) is a self-assessment device, which includes separate measures of state and trait anxiety.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Mar 12, 2012
Registry last updated: Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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