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Functional Dyspepsia Treatment Trial

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyspepsia and Other Specified Disorders of Function of Stomach

Intervention: Amitriptyline (Drug); Escitalopram (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Earnest P Bouras, M.D., Principal Investigator, Affiliation: Mayo Clinic
John K. DiBaise, M.D., Principal Investigator, Affiliation: Mayo Clinic
Colin P Howden, M.D., Principal Investigator, Affiliation: Northwestern University Chicago
Charlene M Prather, M.D., Principal Investigator, Affiliation: St. Louis University
Nicholas J Talley, M.D.,Ph.D., Study Chair, Affiliation: Mayo Clinic
Brian E. Lacy, M.D., Ph.D., Principal Investigator, Affiliation: Dartmouth-Hitchcock Medical Center
G. R. Locke, III, M.D., Principal Investigator, Affiliation: Mayo Clinic
Bincy P Abraham, M.D., M.S., Principal Investigator, Affiliation: Baylor College of Medicine
Hashem El-Serag, M.D., Principal Investigator, Affiliation: Baylor College of Medicine
Paul Moayyedi, M.D., Principal Investigator, Affiliation: McMaster University Centre, Hamilton, Ontario

Summary

Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often interfere with school and work, and weight loss may occur due to dietary restrictions. The hypothesis of this study was that antidepressant therapy is more effective than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The study also examined if antidepressant therapy reduces disability and improves quality of life in functional dyspepsia.

Clinical Details

Official title: Antidepressant Therapy for Functional Dyspepsia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment

Secondary outcome:

Gastric Emptying Half-Time (T1/2)

Maximum Tolerated Volume by Nutrient Drink Test

Dyspepsia-Specific Quality of Life

Detailed description: The aims of this study were to: 1. Determine whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The investigators also planned to determine if antidepressant therapy reduces disability, improves quality of life and influences clinical response over 6 months after ceasing medication. 2. Determine if gastric emptying (motor dysfunction) and the nutrient drink test (a test that assesses gastric hypersensitivity and/or gastric accommodation) is altered by antidepressant therapy with a tricyclic or selective serotonin re-uptake inhibitors (SSRI), and whether subgroups with altered physiology are associated with treatment outcome.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Normal esophagogastroduodenoscopy (EGD) (no esophagitis, Barrett's esophagus, cancer,

erosions, or ulcer disease) within the past 5 years

- Diagnosis of functional dyspepsia

- Patients may have failed to adequately respond to antisecretory therapy in the past

for functional dyspepsia to be suitable; a good response to antisecretory therapy, which remains first line therapy, suggests underlying gastroesophageal reflux disease (GERD). Exclusion Criteria:

- Any documented history of endoscopic esophagitis, or predominant heartburn or acid

regurgitation, or these symptoms two or more times per week in the prior year, to exclude GERD.

- Those who have had an adequate response to antisecretory therapy according to the

physician interview, to exclude patients with disease easy to control with first line therapy or misdiagnosed GERD.

- Any documented peptic ulcer disease.

- Regular use of non-steroidal anti-inflammatory drugs (except long term low dose

aspirin ≤ 325 mg / day)

- Subjects undergoing psychiatric treatment, having a current history of drug or

alcohol abuse, or currently taking psychotropic medication for depression or psychosis, or eating disorders

- A history of abdominal surgery except appendectomy, cholecystectomy or hysterectomy,

tubal ligations, bladder slings, and vasectomies

- Subjects with concurrent major physical illness (including cardiac or liver disease,

diabetes, inflammatory bowel disease, glaucoma, urinary retention, active thyroid disease, vasculitis, lactose intolerance explaining symptoms)

- Subjects whose literacy skills are insufficient to complete self report

questionnaires.

- Pregnancy, or refusal to apply adequate contraceptive measures during the trial

- Subjects currently on antidepressant therapy will be excluded.

- Patients who score 11 or greater on the 7 questions related to depression of the

Hospital Anxiety Depression Scale will be excluded. These patients will be encouraged to get follow up for depression.

- All eligible patients over age 50 will have an EKG before randomization. Those found

to have significant arrhythmias, conduction defects or a previous myocardial infarction on EKG will be excluded. Anyone with QT prolongation will be excluded. The following concomitant medications will be prohibited during the trial:

- Systemically acting cholinergics and anticholinergics (atropine, didinium bromide,

propantheline)

- Prokinetics (e. g., metoclopramide, tegaserod)

- Macrolide antibiotics (e. g., erythromycin, azithromycin)

- Aspirin (> 325 mg/day)

- Spasmolytics (e. g., dicyclomine)

- Antidepressants other than study medications

- Serotonin enhancing drugs: monamine oxidase inhibitors, anticonvulsants,

dextromethorphan. Participants will be instructed to avoid grapefruit/grapefruit juice during the trial.

Locations and Contacts

Mayo Clinic, Scottsdale, Arizona 85259, United States

Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States

Northwestern University Chicago, Chicago, Illinois 60611, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Saint Louis University School of Medicine, Saint Louis, Missouri 63130, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

McMaster University Centre, Hamilton, Ontario, Canada

Baylor College of Medicine, Houston, Texas 77030, United States

Additional Information

Starting date: October 2006
Last updated: June 26, 2014

Page last updated: August 23, 2015

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