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

NCT ID: NCT01551225

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Escitalopram

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

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: 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.

Placebo tablets to Escitalopram

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

Group Type: PLACEBO_COMPARATOR

Escitalopram

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Lexapro

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Kruimel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 33038815 (View on PubMed)

Other Identifiers

102051

Identifier Type: -

Identifier Source: org_study_id