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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Panic Disorder
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Escitalopram Versus Placebo for Patients With Irritable Bowel Syndrome and Panic Disorder

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Escitalopram
40 Patients with IBS and panic disorder treated with Escitalopram.
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
Placebo Comparator: Placebo tablets to Escitalopram
40 Patients with IBS and panic disorder treated with placebo.
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551225

Contacts
Contact: Joanna W Kruimel, MD PhD +31433875021 j.kruimel@mumc.nl
Contact: Carsten Leue, MD +31433877444 c.leue@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Joanna W Kruimel, MD PhD    +31433875021    j.kruimel@mumc.nl   
Contact: Carsten Leue, MD    +31433877444    c.leue@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Joanna Kruimel, MD PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01551225     History of Changes
Other Study ID Numbers: 102051
Study First Received: November 3, 2011
Last Updated: April 10, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Randomized controlled trial
Escitalopram
Irritable bowel syndrome
Panic disorder

Additional relevant MeSH terms:
Disease
Syndrome
Irritable Bowel Syndrome
Panic Disorder
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014