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

Primary Purpose

Irritable Bowel Syndrome, Panic Disorder

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Escitalopram

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Randomized controlled trial, Escitalopram, Irritable bowel syndrome, Panic disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

IBS will be diagnosed according to the Rome III criteria by a gastroenterologist.
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).
Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined.
A panic disorder will be diagnosed based on DSM IV criteria by a psychiatrist.
Age above 18 years and under 70 years.
Given written informed consent.

Exclusion Criteria:

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.
Administration of investigational drugs in the 180 days prior to the study.
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.
Pregnancy and lactation.
Excessive alcohol consumption (> 20 alcoholic consumptions per week) or drug abuse.
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.
Known prolongation of QT-interval or long-QT-syndrome, other cardiac disease, or use of medication with known prolongation of QT-interval.

Sites / Locations

Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Escitalopram

Placebo tablets to Escitalopram

Arm Description

17 or 18 Patients with IBS and panic disorder treated with Escitalopram.

17 or 18 Patients with IBS and panic disorder treated with placebo.

Outcomes

Primary Outcome Measures

Gastrointestinal Symptom Rating Scale (GSRS).

Gastrointestinal Symptom Rating Scale (GSRS) is a self-assessment questionnaire for gastrointestinal symptoms.

State Trait Anxiety Inventory (STAI).

State Trait Anxiety Inventory (STAI) is a self-assessment device, which includes separate measures of state and trait anxiety.

Secondary Outcome Measures

Full Information

NCT ID

NCT01551225

First Posted

November 3, 2011

Last Updated

January 11, 2017

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01551225

Brief Title

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

Official Title

Randomized Controlled Trial of Escitalopram Versus Placebo for Patients With Irritable Bowel Syndrome and Panic Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Panic Disorder

Keywords

Randomized controlled trial, Escitalopram, Irritable bowel syndrome, Panic disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Escitalopram

Arm Type

Active Comparator

Arm Description

17 or 18 Patients with IBS and panic disorder treated with Escitalopram.

Arm Title

Placebo tablets to Escitalopram

Arm Type

Placebo Comparator

Arm Description

17 or 18 Patients with IBS and panic disorder treated with placebo.

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Lexapro

Intervention Description

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.

Primary Outcome Measure Information:

Title

Gastrointestinal Symptom Rating Scale (GSRS).

Description

Gastrointestinal Symptom Rating Scale (GSRS) is a self-assessment questionnaire for gastrointestinal symptoms.

Time Frame

Change from baseline in outcome of GSRS at 6 months.

Title

State Trait Anxiety Inventory (STAI).

Description

State Trait Anxiety Inventory (STAI) is a self-assessment device, which includes separate measures of state and trait anxiety.

Time Frame

Change from baseline in outcome of STAI at 6 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: IBS will be diagnosed according to the Rome III criteria by a gastroenterologist. 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). Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined. A panic disorder will be diagnosed based on DSM IV criteria by a psychiatrist. Age above 18 years and under 70 years. Given written informed consent. Exclusion Criteria: 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. Administration of investigational drugs in the 180 days prior to the study. 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. Pregnancy and lactation. Excessive alcohol consumption (> 20 alcoholic consumptions per week) or drug abuse. 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. Known prolongation of QT-interval or long-QT-syndrome, other cardiac disease, or use of medication with known prolongation of QT-interval.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joanna Kruimel, MD PhD

Organizational Affiliation

Maastricht University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Center

City

Maastricht

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

33038815

Citation

Drukker M, Peters JCH, Vork L, Mujagic Z, Rutten BPF, van Os J, Masclee AAM, Kruimel JW, Leue C. Network approach of mood and functional gastrointestinal symptom dynamics in relation to childhood trauma in patients with irritable bowel syndrome and comorbid panic disorder. J Psychosom Res. 2020 Dec;139:110261. doi: 10.1016/j.jpsychores.2020.110261. Epub 2020 Oct 2.

Results Reference

derived

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

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