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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Active Comparator | 17 or 18 Patients with IBS and panic disorder treated with Escitalopram. |
|
| Placebo tablets to Escitalopram | Placebo Comparator | 17 or 18 Patients with IBS and panic disorder treated with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Kruimel, MD PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33038815 | Derived | 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. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
|
| D004066 | Digestive System Diseases |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |