Functional Dyspepsia Treatment Trial - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00248651

Purpose

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 Drug: escitalopram Drug: placebo	Phase II Phase III

MedlinePlus related topics: Antidepressants Indigestion

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Amitriptyline Amitriptyline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Antidepressant Therapy for Functional Dyspepsia

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

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess whether gastric emptying and the nutrient drink test is altered by therapy with a tricyclic or SSRI antidepressant. [ Time Frame: end of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator amitriptyline	Drug: Amitriptyline 25mg by mouth at bedtime for two weeks, then 50 mg by mouth at bedtime for 10 weeks.
2: Active Comparator escitalopram	Drug: escitalopram 10mg by mouth at bedtime for 12 weeks
3: Placebo Comparator	Drug: placebo placebo

Detailed 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:

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.
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.
Determine if polymorphisms of GNβ3 and the serotonin reuptake transporter predict outcome in functional dyspepsia patients receiving a tricyclic antidepressant or SSRI therapy.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248651

Contacts

Contact: Vickie M Silvernail, LPN	507-284 ext 2812	silvernail.vickie@mayo.edu
Contact: Judy A Peterson, CCRP	507-266 ext 9740	peterson.judy@mayo.edu

Locations

United States, Arizona
Mayo Clinic	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Andre R Watkins 480-301-8000 ext 2-9048 watkins.andre@mayo.edu
Principal Investigator: John K. Dibaise, M.D.
Sub-Investigator: Michael D. Crowell, Ph.D.
United States, Florida
Mayo Clinic Jacksonville	Recruiting
Jacksonville, Florida, United States, 32224
Contact: Verna Skinner 904-953-2000 ext 3-2255 skinner.verna@mayo.edu
Principal Investigator: Earnest P Bouras, M.D.
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Michael P. Jones, M.D. 312-695-4054
Contact: Jason R Bratten 312-695-2742 j-bratten@northwestern.edu
Principal Investigator: Michael P Jones, M.D.
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Vickie M Silvernail, L.P.N. 507-284-2511 ext 2812 silvernail.vickie@mayo.edu
Contact: Judy A Peterson, CCRP 507-284-2511 ext 9740 peterson.judy@mayo.edu
Principal Investigator: Nicholas J Talley, M.D.,Ph.D.
Sub-Investigator: G. R. Locke, III, M.D.
United States, Missouri
Saint Louis University School od Medicine	Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Charlene M. Prather, M.D. 314-577-8764 pratherc@slu.edu
Contact: Debra King, R.N. 314-977-9320 kingdl@slu.edu
Principal Investigator: Charlene M Prather, M.D.
United States, New Hampshire
Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Brian E. Lacy, M.D., Ph.D. 603-650-5215
Contact: Laurie A. Skinner 603-653-3667 Laurie.A.Skinner@hitchcock.org
Principal Investigator: Brian E. Lacy, M.D.

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:	Earnest P Bouras, M.D.	Mayo Clinic
Principal Investigator:	John K. DiBaise, M.D.	Mayo Clinic Scottsdale
Principal Investigator:	Michael P Jones, M.D.	Northwestern Memorial Hospital
Principal Investigator:	Charlene M Prather, M.D.	St. Louis University
Principal Investigator:	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

More Information

Responsible Party:	Mayo Clinic ( Nicholas J. Talley, M.D., Ph.D. )
Study ID Numbers:	2021-05
Study First Received:	November 3, 2005
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00248651
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Bloating
Early Fullness
Nausea
Upper Abdominal Discomfort
dyspepsia

Study placed in the following topic categories:

Signs and Symptoms, Digestive
Gastrointestinal Diseases
Dyspepsia
Citalopram
Serotonin
Signs and Symptoms
Digestive System Diseases

Stomach Diseases
Amitriptyline
Nausea
Gastroenteritis
Dexetimide
Gastritis

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Antidepressive Agents, Tricyclic

Serotonin Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 14, 2009