Escitalopram Trial for Irritable Bowel Syndrome (IBS) Patients With Panic Disorder
Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Irritable Bowel Syndrome; Panic Disorder
Intervention: Escitalopram (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Maastricht University Medical Center Official(s) and/or principal investigator(s): Joanna Kruimel, MD PhD, Principal Investigator, Affiliation: Maastricht University Medical Center
Overall contact: Joanna W Kruimel, MD PhD, Phone: +31433875021, Email: j.kruimel@mumc.nl
Summary
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.
Clinical Details
Official title: Randomized Controlled Trial of Escitalopram Versus Placebo for Patients With Irritable Bowel Syndrome and Panic Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Gastrointestinal Symptom Rating Scale (GSRS).State Trait Anxiety Inventory (STAI).
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. IBS will be diagnosed according to the Rome III criteria by a gastroenterologist.
2. 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).
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 by a psychiatrist.
5. Age above 18 years and under 70 years.
6. Given written informed consent.
Exclusion Criteria:
1. 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.
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 consumptions per week) or drug abuse.
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
SSRI's 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.
Locations and Contacts
Joanna W Kruimel, MD PhD, Phone: +31433875021, Email: j.kruimel@mumc.nl
Maastricht University Medical Center, Maastricht, Netherlands; Recruiting Joanna W Kruimel, MD PhD, Phone: +31433875021, Email: j.kruimel@mumc.nl Carsten Leue, MD, Phone: +31433877444, Email: c.leue@mumc.nl
Additional Information
Starting date: January 2012
Last updated: May 4, 2015
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