Functional Dyspepsia Treatment Trial - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Indigestion

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

U.S. FDA Resources

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 2011
Estimated Primary Completion Date:	December 2011 (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, CCRP	877-825-8999	silvernail.vickie@mayo.edu
Contact: Linda M Herrick, PhD, RN	507-284-2812	herrick.linda@mayo.edu

Locations

United States, Arizona
Mayo Clinic	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Machiko (Tina) H. Anderson 480-301-8000 ext 2-7056 anderson.machiko@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 904-953-0703 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. 507-284-2812 silvernail.vickie@mayo.edu
Contact: Linda M Herrick, Ph.D. 507-284-2511 herrick.linda@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 of 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: Carol A. Moriarty, R.N. 603-653-3665 carol.a.moriarty@hitchcock.org
Principal Investigator: Brian E. Lacy, M.D.
United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Bincy P Abraham, M.D., M.S. 713-798-0950 bincya@bcm.tmc.edu
Contact: Sara A. Raymon, BA/CCRP 713-798-7616 raymon@bcm.tmc.edu
Principal Investigator: Bincy P. Abraham, M.D., M.S.

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
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
Principal Investigator:	Bincy P Abraham, M.D., M.S.	Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Nicholas J. Talley, M.D., Ph.D. )
Study ID Numbers:	2021-05 (DK65713)
Study First Received:	November 3, 2005
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00248651 History of Changes
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
stomach pain
stomach discomfort

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Signs and Symptoms, Digestive
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Signs and Symptoms
Stomach Diseases
Sensory System Agents
Therapeutic Uses
Analgesics
Antidepressive Agents, Second-Generation

Antidepressive Agents
Dyspepsia
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Serotonin Agents
Digestive System Diseases
Analgesics, Non-Narcotic
Amitriptyline
Peripheral Nervous System Agents
Gastroenteritis
Gastritis
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 04, 2010