Functional Dyspepsia Treatment Trial (FDTT)
|ClinicalTrials.gov Identifier: NCT00248651|
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
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|
The aims of this study were to:
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||292 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Antidepressant Therapy for Functional Dyspepsia|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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.
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.
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.
Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.
- 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.
- Gastric Emptying Half-Time (T1/2) [ Time Frame: 12 weeks ]The time for half of the ingested solids or liquids to leave the stomach.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248651
|United States, Arizona|
|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|
|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|
|McMaster University Centre|
|Hamilton, Ontario, Canada|
|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|