Trial record 2 of 29 for:
Open Studies | "Panic Disorder"
Escitalopram Trial for Irritable Bowel Syndrome (IBS) Patients With Panic Disorder
This study is currently recruiting participants.
Verified March 2012 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01551225
First received: November 3, 2011
Last updated: March 12, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome Panic Disorder |
Drug: Escitalopram |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of Escitalopram Versus Placebo for Patients With Irritable Bowel Syndrome and Panic Disorder |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- Gastrointestinal Symptom Rating Scale (GSRS). [ Time Frame: Change from baseline in outcome of GSRS at 6 months. ] [ Designated as safety issue: No ]Gastrointestinal Symptom Rating Scale (GSRS) is a self-assessment questionnaire for gastrointestinal symptoms.
- State Trait Anxiety Inventory (STAI). [ Time Frame: Change from baseline in outcome of STAI at 6 months. ] [ Designated as safety issue: No ]State Trait Anxiety Inventory (STAI) is a self-assessment device, which includes separate measures of state and trait anxiety.
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Escitalopram
40 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
40 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 65 years.
- Given written informed consent.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551225
Contacts
| Contact: Joanna W Kruimel, MD PhD | +31433875021 | j.kruimel@mumc.nl |
| Contact: Carsten Leue, MD | +31433877444 | c.leue@mumc.nl |
Locations
| Netherlands | |
| Maastricht University Medical Center | Recruiting |
| Maastricht, Netherlands | |
| Contact: Joanna W Kruimel, MD PhD +31433875021 j.kruimel@mumc.nl | |
| Contact: Carsten Leue, MD +31433877444 c.leue@mumc.nl | |
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
| Principal Investigator: | Joanna Kruimel, MD PhD | Maastricht University Medical Center |
More Information
No publications provided
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01551225 History of Changes |
| Other Study ID Numbers: | 102051 |
| Study First Received: | November 3, 2011 |
| Last Updated: | March 12, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
Randomized controlled trial Escitalopram Irritable bowel syndrome Panic disorder |
Additional relevant MeSH terms:
|
Panic Disorder Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Anxiety Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013