Functional Dyspepsia Treatment Trial (FDTT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
G. Richard Locke, III, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00248651
First received: November 3, 2005
Last updated: May 28, 2013
Last verified: May 2013

November 3, 2005
May 28, 2013
October 2006
July 2013   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00248651 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Functional Dyspepsia Treatment Trial
Antidepressant Therapy for Functional Dyspepsia

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Functional Dyspepsia
  • Drug: Amitriptyline
    25mg by mouth at bedtime for two weeks, then 50 mg by mouth at bedtime for 10 weeks.
  • Drug: escitalopram
    10mg by mouth at bedtime for 12 weeks
    Other Name: Lexapro
  • Drug: placebo
    placebo
  • Active Comparator: 1
    amitriptyline
    Intervention: Drug: Amitriptyline
  • Active Comparator: 2
    escitalopram
    Intervention: Drug: escitalopram
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Talley NJ, Locke GR 3rd, Herrick LM, Silvernail VM, Prather CM, Lacy BE, DiBaise JK, Howden CW, Brenner DM, Bouras EP, El-Serag HB, Abraham BP, Moayyedi P, Zinsmeister AR. Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics. Contemp Clin Trials. 2012 May;33(3):523-33. doi: 10.1016/j.cct.2012.02.002. Epub 2012 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00248651
2021-05 (DK65713), U01DK065713
Yes
G. Richard Locke, III, M.D., Mayo Clinic
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Earnest P Bouras, M.D. Mayo Clinic
Principal Investigator: John K. DiBaise, M.D. Mayo Clinic
Principal Investigator: Colin P Howden, M.D. Northwestern University Chicago
Principal Investigator: Charlene M Prather, M.D. St. Louis University
Study Chair: 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
Principal Investigator: Hashem El-Serag, M.D. Baylor College of Medicine
Principal Investigator: Paul Moayyedi, M.D. McMaster University Centre, Hamilton, Ontario
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP