Functional Dyspepsia Treatment Trial (FDTT)
Number of Subjects in Study Archive: 292
Study Design: Interventional
Conditions: Diabetes Mellitus, Type 1, Dyspepsia
Duration: Oct 2006 – July 2013
# Recruitment Centers: 8
Treatment: Amitriptyline and Escitalopram
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: https://clinicaltrials.gov/ct2/show/NCT00248651
Functional dyspepsia (FD) is a common problem affecting up to 10-25% of individuals, and accounts for significant health care costs and affects quality of life. Currently there is no definitive treatment for FD, though antidepressants are used in the treatment of FD, but are considered unsatisfactory. The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (amitriptyline or escitalopram) leads to improvement of symptoms in patients with moderate to severe FD.
This study had two main objectives. Firstly, 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. Secondly, to 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.
Primary Outcome Measures:
- Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment
Secondary Outcome Measures:
Gastric Emptying Half-Time
Maximum Tolerated Volume by Nutrient Drink Test: 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.
Dyspepsia-Specific 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.
Patients between the ages of 18 and 75 years with normal esophagogastroduodenoscopy (EGD) and a diagnosis of dyspepsia may participate in this study.
Patients with any documented history of endoscopic esophagitis, or predominant heartburn or acid regurgitation, and a history of abdominal surgery (except appendectomy, cholecystectomy or hysterectomy, tubal ligations, bladder slings, and vasectomies) may participate in this study.
Amitriptyline, but not escitalopram, appears to benefit some patients with FD, particularly those with ulcer-like (painful) FD. Patients with delayed GE do not respond to these drugs.