This trial is active, not recruiting.

Condition functional dyspepsia
Treatments amitriptyline, escitalopram, placebo
Phase phase 2/phase 3
Sponsor Mayo Clinic
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2006
End date July 2013
Trial size 400 participants
Trial identifier NCT00248651, 2021-05 (DK65713), NCT00275626, U01DK065713


The investigators propose to examine whether antidepressant medications are efficacious in functional dyspepsia. The prescription of antidepressants to treat functional dyspepsia is based on three propositions. First, antidepressants could reduce the severity of co-morbid psychological symptoms, especially anxiety and depression. Second, antidepressants have central analgesic actions. Third, antidepressants have been shown to have local pharmacological actions on the gut, and may specifically alter gastric emptying and fundic relaxation based on preliminary data, but the relevance of such perturbations to treatment outcome is not established.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
25mg by mouth at bedtime for two weeks, then 50 mg by mouth at bedtime for 10 weeks.
(Active Comparator)
escitalopram Lexapro
10mg by mouth at bedtime for 12 weeks
(Placebo Comparator)

Primary Outcomes

Assess whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity.
time frame: end of study

Secondary Outcomes

Assess whether gastric emptying and the nutrient drink test is altered by therapy with a tricyclic or SSRI antidepressant.
time frame: end of study
Examine whether polymorphisms of the heterotrimeric G protein and serotonin reuptake transporter predict outcome in functional dyspepsia patients receiving antidepressant therapy.
time frame: end of study

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Patients will have had in the prior 5 year, a normal esophagogastroduodenoscopy (EGD) (no esophagitis, Barrett's esophagus, cancer, erosions, or ulcer disease), and will have been diagnosed with functional dyspepsia after specialist consultation. - Patients will 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 GERD (8). 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). - Subjects undergoing psychiatric treatment, having a history of drug or alcohol abuse, or currently taking psychotropic medication (psychiatric diagnoses will not be an exclusion, except for psychosis). - A history of abdominal surgery except appendectomy, cholecystectomy or hysterectomy more than one year previously. - 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), psychotic illness or eating disorder. - Subjects whose literacy skills are insufficient to complete self report questionnaires. - Pregnancy, or refusal to apply adequate contraceptive measures during the trial.

Additional Information

Official title Antidepressant Therapy for Functional Dyspepsia
Principal investigator Earnest P Bouras, M.D.
Description In a parallel group, double blind, randomized, placebo-controlled adequately powered three-arm,multi-center trial, the aims of the present study are 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 will also 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 SSRI, and whether subgroups with altered physiology are associated with treatment outcome. In a sub-study, the investigators will directly determine if impaired gastric accommodation (by a novel validated non-invasive imaging method using 99mTc-SPECT) and the symptom response to a nutrient drink test is altered by an SSRI or tricyclic antidepressant. 3. Determine if polymorphisms of GNβ3 and the serotonin reuptake transporter predict outcome in functional dyspepsia patients receiving a tricyclic antidepressant or SSRI therapy.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Mayo Clinic.