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Functional Dyspepsia | Tricyclic Antidepressants (TCAs) on Gastric Emptying

Functional Dyspepsia research study

What is the primary objective of this study?

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 newly developed scintigraphic test that simultaneously measures both gastric emptying and gastric volume (accommodation). These two tricyclic antidepressant agents are commonly used at low doses to treat patients with refractory functional dyspepsia.

Who is eligible to participate?

Inclusion Criteria: - Sixty normal subjects, males and females within the ages of 18 to 65 years, will be studied. Normal control subjects will be recruited for voluntary participation through poster advertisements. A normal subject is defined as a person with no gastrointestinal (GI) symptoms; no prior history of peptic ulcer disease or irritable bowel disease; no previous history of a GI motility disorder (including, but not limited to, achalasia, gastroparesis); on no medications for GI disorders; no history of prior surgery on the GI tract (esophagus, stomach, large or small intestine); and a normal physical examination. Exclusion Criteria: - History of a motility disorder (including, but not limited to, achalasia, gastroparesis) - History of peptic ulcer disease - Symptoms referable to gastric dysmotility (nausea, vomiting, early satiety, heartburn, postprandial abdominal distension) - Use of medications that may affect GI motor function (beta adrenergic receptor blockers, calcium channel blockers, histamine type 2 receptor antagonists, proton pump inhibitors, prokinetic agents, antidepressants, and the use of narcotic analgesics) - Regular use of nonsteroidal anti-inflammatory medications - Use of monoamine oxidase inhibitors - Pregnancy or breast feeding - Prior gastrointestinal surgery (except appendectomy) - Contraindications to amitriptyline or desipramine, which will be exclusion criteria to the study, include hypersensitivity or allergy to any tricyclic drug, concomitant therapy with a monoamine oxidase inhibitor, recent myocardial infarction, myelography within previous 48 hours, or lactation. In addition, history of prostate problems, history of urinary retention, known glaucoma, history of seizures, or thyroid or liver dysfunction are exclusionary criteria to the use of TCAs and to entry into this study.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Functional Dyspepsia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Desipramine

Drug:Amitriptyline

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: September 2005

Completed Date: September 2007

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Gastric emptying

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Henry P Parkman, MD

Lead Sponsor: Temple University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00220844

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