Functional Dyspepsia Treatment Trial

2014-08-27 03:47:51 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Functional Dyspepsia


Amitriptyline, escitalopram, placebo


Mayo Clinic
United States




Mayo Clinic

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:47:51-0400

Clinical Trials [580 Associated Clinical Trials listed on BioPortfolio]

Lansoprazole for Subgroups of Functional Dyspepsia

Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials reported conflicting results on clinical effectiveness of proton pump inhibitor in patients with...

Tricyclic Antidepressants (TCAs) on Gastric Emptying

The purpose of this study is to determine the effects of two tricyclic antidepressant agents (TCAs), amitriptyline and desipramine, on gastric emptying and gastric accommodation using a ne...

Itopride in Functional Dyspepsia:a Dose Finding Study

This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the treatment of patients with functional dyspepsia. The study will test in patients with functio...

SSRI Study for Functional Dyspepsia (SS)

Background: Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia (FD) is uncertain. Clinical experience and community studies sh...

The Effect of Z-338 in Subjects With Functional Dyspepsia

Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultras...

PubMed Articles [7087 Associated PubMed Articles listed on BioPortfolio]

Escitalopram augmentation improves negative symptoms of treatment resistant schizophrenia patients - A randomized controlled trial.

Serum interleukin (IL)-6 levels in schizophrenia correlate with the severity of negative symptoms. This study aimed to explore the potential immune mechanism of SSRI augmentation in the management of ...

Functional Modulation of Na1.2 Voltage-Gated Sodium Channels Induced by Escitalopram.

Escitalopram, a selective serotonin reuptake inhibitor (SSRI), may induce seizures, particularly in epileptic patients. In this study, we investigated the effect of escitalopram in Na1.2 voltage-gated...

Efficacy of Tianeptine 25-50 mg in Elderly Patients With Recurrent Major Depressive Disorder: An 8-Week Placebo- and Escitalopram-Controlled Study.

The present placebo-controlled study evaluated the efficacy and safety of 8 weeks of treatment with tianeptine 25-50 mg/d in elderly patients suffering from major depressive disorder (MDD) according t...

New Approaches to Diagnosis and Treatment of Functional Dyspepsia.

The purpose of this article is to review the recent literature and discuss the new approaches to the diagnosis and treatment of functional dyspepsia (FD).

Overlap of Irritable Bowel Syndrome and Functional Dyspepsia in the Clinical Setting: Prevalence and Risk Factors.

According to Rome IV criteria, functional dyspepsia (FD) and irritable bowel syndrome (IBS) are distinct functional gastrointestinal disorders (FGID); however, overlap of these conditions is common in...

Medical and Biotech [MESH] Definitions

A substituted benzamide used for its prokinetic properties. It is used in the management of gastroesophageal reflux disease, functional dyspepsia, and other disorders associated with impaired gastrointestinal motility. (Martindale The Extra Pharmacopoeia, 31st ed)

Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.

Impaired digestion, especially after eating.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

A tricyclic antidepressant with actions similar to AMITRIPTYLINE.

More From BioPortfolio on "Functional Dyspepsia Treatment Trial"

Quick Search


Relevant Topics

Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Bipolar Disorders
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Over half of Bipolar cases develops before the age of 25. Bipolar ...

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Searches Linking to this Trial