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Functional Dyspepsia Treatment Trial (FDTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00248651
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Dyspepsia and Other Specified Disorders of Function of Stomach Drug: Amitriptyline Drug: Escitalopram Drug: Placebo Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Antidepressant Therapy for Functional Dyspepsia
Study Start Date : October 2006
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Amitriptyline
Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
 Drug: Amitriptyline
25 mg capsule by mouth at bedtime for two weeks, then 50 mg capsule by mouth at bedtime for 10 weeks. The drug will be provided in blister packs.
Other Name: Elavil
Active Comparator: Escitalopram
Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
 Drug: Escitalopram
10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.
Other Name: Lexapro
Placebo Comparator: Placebo
Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
 Drug: Placebo
Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.


Outcome Measures
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Primary Outcome Measures :
  1. Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment [ Time Frame: 3 weeks through 12 weeks ]
    The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.


Secondary Outcome Measures :
  1. Gastric Emptying Half-Time (T1/2) [ Time Frame: 12 weeks ]
    The time for half of the ingested solids or liquids to leave the stomach.

  2. Maximum Tolerated Volume by Nutrient Drink Test [ Time Frame: 12 weeks ]
    The nutrient drink test for meal-induced satiety had subjects drink 120 ml of ENSURE every four minutes. Satiety scores were measured on a scale graded 0-5 (1, no symptoms; 5, maximum satiety). When a score of 5 was reached, the maximum tolerated volume intake was measured. Abnormal satiety was defined as inability to consume > 800 ml of Ensure.

  3. Dyspepsia-Specific Quality of Life [ Time Frame: 12 Weeks ]
    The Nepean Dyspepsia Index (NDI) assessed quality of life. NDI scores are summarized into overall quality of life and 5 subscales: Interference, Knowledge/Control, Eating/Drinking, Sleep Disturbance, Work/Study. The scale consists of 25 items, yielding 5 sub-scales. Range 0-100, higher numbers indicate a greater quality of life.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248651


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
Northwestern University Chicago
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis University School of Medicine
Saint Louis, Missouri, United States, 63130
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Canada, Ontario
McMaster University Centre
Hamilton, Ontario, Canada
Sponsors and Collaborators
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Earnest P Bouras, M.D. Mayo Clinic
Principal Investigator: John K. DiBaise, M.D. Mayo Clinic
Principal Investigator: Colin P Howden, M.D. Northwestern University Chicago
Principal Investigator: Charlene M Prather, M.D. St. Louis University
Study Chair: Nicholas J Talley, M.D.,Ph.D. Mayo Clinic
Principal Investigator: Brian E. Lacy, M.D., Ph.D. Dartmouth-Hitchcock Medical Center
Principal Investigator: G. R. Locke, III, M.D. Mayo Clinic
Principal Investigator: Bincy P Abraham, M.D., M.S. Baylor College of Medicine
Principal Investigator: Hashem El-Serag, M.D. Baylor College of Medicine
Principal Investigator: Paul Moayyedi, M.D. McMaster University Centre, Hamilton, Ontario
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Yuri A. Saito Loftus, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00248651    
Obsolete Identifiers: NCT00275626
Other Study ID Numbers: 2021-05 (DK065713)
U01DK065713 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2005    Key Record Dates
Results First Posted: July 25, 2014
Last Update Posted: July 25, 2014
Last Verified: June 2014
Keywords provided by Yuri A. Saito Loftus, Mayo Clinic:
Bloating
Early Fullness
Nausea
Upper Abdominal Discomfort
 dyspepsia
stomach pain
stomach discomfort
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Amitriptyline
Escitalopram
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
 Physiological Effects of Drugs
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Antidepressive Agents, Tricyclic
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents