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

This study is currently recruiting participants.
Verified March 2012 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01551225
First received: November 3, 2011
Last updated: March 12, 2012
Last verified: March 2012

November 3, 2011
March 12, 2012
January 2012
January 2014   (final data collection date for primary outcome measure)
  • Gastrointestinal Symptom Rating Scale (GSRS). [ Time Frame: Change from baseline in outcome of GSRS at 6 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    State Trait Anxiety Inventory (STAI) is a self-assessment device, which includes separate measures of state and trait anxiety.
Same as current
Complete list of historical versions of study NCT01551225 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Escitalopram Trial for Irritable Bowel Syndrome (IBS) Patients With Panic Disorder
Randomized Controlled Trial of Escitalopram Versus Placebo for Patients With Irritable Bowel Syndrome and 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Irritable Bowel Syndrome
  • Panic Disorder
Drug: Escitalopram
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 Name: Lexapro
  • Active Comparator: Escitalopram
    40 Patients with IBS and panic disorder treated with Escitalopram.
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo tablets to Escitalopram
    40 Patients with IBS and panic disorder treated with placebo.
    Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2014
January 2014   (final data collection date for primary outcome measure)

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 65 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.
Both
18 Years to 65 Years
No
Contact: Joanna W Kruimel, MD PhD +31433875021 j.kruimel@mumc.nl
Contact: Carsten Leue, MD +31433877444 c.leue@mumc.nl
Netherlands
 
NCT01551225
102051
Yes
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Joanna Kruimel, MD PhD Maastricht University Medical Center
Maastricht University Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP