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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551225
• Other study ID #: 102051
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2011
• Last updated: January 11, 2017
• Start date: January 2012
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Irritable Bowel Syndrome
• Panic Disorder
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Symptom Rating Scale (GSRS).	Gastrointestinal Symptom Rating Scale (GSRS) is a self-assessment questionnaire for gastrointestinal symptoms.	Change from baseline in outcome of GSRS at 6 months.	No
Primary	State Trait Anxiety Inventory (STAI).	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.	No