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

• ClinicalTrials.gov Identifier: NCT01551225
• Recruitment Status: Completed
• First Posted: March 12, 2012
• Last Update Posted: January 12, 2017
• Sponsor: Maastricht University Medical Center
• Information provided by (Responsible Party): Maastricht University Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome; Panic Disorder	Drug: Escitalopram	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Escitalopram Versus Placebo for Patients With Irritable Bowel Syndrome and Panic Disorder
• Study Start Date: January 2012
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

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 Name: 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 Name: Lexapro

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT01551225
• Other Study ID Numbers: 102051
• First Posted: March 12, 2012
• Last Update Posted: January 12, 2017
• Last Verified: July 2016

Keywords provided by Maastricht University Medical Center:

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

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Disease; Syndrome; Panic Disorder; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Anxiety Disorders; Mental Disorders; Citalopram; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs