We propose to investigate 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. Thirdly, 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 pertubations to treatment outcome is not established.

Condition	Intervention	Phase
Functional Dyspepsia	Drug: Amitriptyline; Escitalopram	Phase II Phase III

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcomes: 1.Assess whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity.
Secondary Outcomes: 2. . Assess whether gastric emptying and the nutrient drink test is altered by therapy with a tricyclic or SSRI antidepressant.; 3.Examine whether polymorphisms of the heterotrimeric G protein and serotonin reuptake transporter predict outcome in functional dyspepsia patients receiving antidepressant therapy.
Expected Total Enrollment:  400

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. We 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, we 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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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).

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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.

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Please refer to this study by ClinicalTrials.gov identifier  NCT00248651

Mary J Rucker, R.N.,CCRP      507-266  Ext. 1288    rucker,mary@mayo.edu

Alabama
      University South Alabama, Mobile,  Alabama,  United States
Arizona
      Mayo Clinic, Scottsdale,  Arizona,  85259,  United States
Florida
      Mayo Clinic Jacksonville, Jacksonville,  Florida,  32224,  United States
Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States
Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States
Missouri
      Saint Louis University School od Medicine, Saint Louis,  Missouri,  United States

Study chairs or principal investigators

Earnest P Bouras, M.D.,  Principal Investigator,  Mayo Clinic Jacksonville   
Michael D Crowell, Ph.D.,  Principal Investigator,  Mayo Clinic Scottsdale   
Kevin W Olden, M.D.,  Principal Investigator,  University of Southern Alabama   
Michael P Jones, M.D.,  Principal Investigator,  Northwestern Memorial Hospital   
Charlene M Prather, M.D.,  Principal Investigator,  St. Louis University   
Nicholas J Talley, M.D.,Ph.D.,  Principal Investigator,  Mayo Clinic Rochester   

Study ID Numbers:  2021-05
Last Updated:  December 8, 2005
Record first received:  November 3, 2005
ClinicalTrials.gov Identifier:  NCT00248651
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10