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
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