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

NCT01551225 | Completed Phase 4 DMC

• 1 other identifier: 102051
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Panic Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Escitalopram

ACTIVE COMPARATOR

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

Drug: Escitalopram

Placebo tablets to Escitalopram

PLACEBO COMPARATOR

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

Drug: Escitalopram

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Escitalopram; Placebo tablets to Escitalopram

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33038815 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Panic Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joanna Kruimel, MD PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: March 12, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2016-07

Locations

NL (1)