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

January 11, 2017 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Escitalopram
17 or 18 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 Names:
  • Lexapro
Placebo Comparator: Placebo tablets to Escitalopram
17 or 18 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 Names:
  • Lexapro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline in outcome of GSRS at 6 months.
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.
Change from baseline in outcome of STAI at 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Joanna Kruimel, MD PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 3, 2011

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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