IBS and panic disorder
Conditions
Interventions
Trade Name: escitalopram
Product Name: Escitalopram
Product Code: NL/H/0984/001
Pharmaceutical Form: Tablet
Other descriptive name: Escitalopram
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
MUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of Escitalopram vs placebo in the treatment of IBS patients with panic disorder;Secondary Objective: - effect of Escitalopram on gastrointestinal and psychiatric symptoms - effect of Escitalopram on quality of life - effect of Escitalopram on visceral perception - effect of Escitalopram on intestinal permeability - effect of Escitalopram on immune status, neurohormones, purinergic signalling and (epi)genetic changes;Primary end point(s): Gastrointestinal Symptom Rating Scale (GSRS) (Self-assessment questionnaire for gastrointestinal symptoms. State Trait Anxiety Inventory (STAI) (Self-assessment device, which includes separate measures of state and trait anxiety). ;Timepoint(s) of evaluation of this end point: At start, after 3 months, after 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hospital Anxiety and Depression Scale (HADS). Cognitive Scale for Functional Bowel Disorders (CS-FBD). Symptom diary. Experience Sampling Method (ESM). Rectal barostat. Sugar permeability test. Laboratory measures for immunology, neurohormones, (Epi)genetic factors.;Timepoint(s) of evaluation of this end point: Start of study, after 3 months, after 6 months for the questionnaires and lab. Rectal barostat and Sugar permeability test only at start of study and after 6 months. | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Center Maastricht
MUMC
Outcome results
None listed