Tricyclic Antidepressants (TCAs) on Gastric Emptying

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00220844
First received: September 19, 2005
Last updated: February 8, 2006
Last verified: September 2005
  Purpose

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.


Condition Intervention
Functional Dyspepsia
Drug: Desipramine
Drug: Amitriptyline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Tricyclic Antidepressant Agents on Gastric Accommodation and Emptying

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Gastric emptying
  • Gastric volume

Estimated Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: September 2007
Detailed Description:

The normal control subjects will be randomized to receive either amitriptyline or desipramine as the tricyclic antidepressant agent, with 30 subjects per group. Subjects will undergo two outpatient gastric emptying/volume tests and two satiety tests; one of each after 7 days of treatment with oral consumption of the study agent and the other one of each after 7 days of treatment with placebo. The order of the treatments (active drug or placebo) will be randomized with 7 days washout between the studies. During the study, the subjects will consume their regular diet. Subjects will also be randomized to receive either amitriptyline 25 mg po qhs as the active drug or desipramine 25 mg po qhs as the active drug. Side effects of the agents will be monitored during the study.

Each subject will undergo a brief history and physical exam prior to entering the study. The subject will have height and weight measured. A questionnaire will be administered to the subject inquiring about gastrointestinal symptoms and medical history. This is to screen for a history of underlying pulmonary, cardiovascular, or gastrointestinal disease. Females will be studied only during the follicular phase (days 1-10) of the menstrual cycle, to minimize the effect of the menstrual cycle on motility (Wald, at al). In addition, females will be given pregnancy screening with a urine beta-human chorionic gonadotropin pregnancy test (Sure-Vue; Fisher Scientific, Inc) prior to the start of the study.

For the simultaneous gastric volume/emptying tests, subjects will be studied in the fasting condition. The study subject history and physical examination form will be filled out which captures information on symptoms for the last week. An intravenous line will be started. The subject will take study medication with a small sip of water. After 10 minutes, 10 mCi 99mTc pertechnetate will be infused intravenously over 30 seconds. Imaging of the stomach will be performed with a gamma camera 20 minutes after injection with both anterior and posterior imaging followed by SPECT imaging using the General Electric Dual Head MAXXUS (General Electric Medical Systems) connected to a General Electric Starcam 4000i computer. A total of 360o rotation around the subject will be obtained using a circular orbit (32 stops at 15 sec per stop) with the heads for the camera close to the subject. After this, the patient will ingest an egg sandwich labeled with 300 µCi 111Indium-oxine cooked into the eggs to label the solid material. The subject will consume 300 ml of unlabelled water. Imaging will then commence immediately after meal ingestion (time 0) for 111In counts to assess solid-phase gastric emptying using both anterior and posterior imaging. This will be followed immediately by imaging for the 99mTc counts to assess gastric volumes. Imaging for 99mTc will be performed with SPECT 3-D imaging. These will be repeated at 20, 40, 60, 80, 100, 120, 150, 180, 210, and 240 minutes after the meal ingestion. Our prior studies show that 4 hour gastric emptying best characterizes gastric emptying. Peak gastric accommodation occurs at 0-40 minutes. At the time of each imaging, symptoms will be monitored. Symptoms of abdominal fullness, nausea, abdominal discomfort, and bloating will be graded by the study subject from 0 (none) to 5 (severe). In addition, an inquiry into possible side effects to TCAs (sedation, confusion, disturbed concentration, dry mouth, constipation, nausea, and urinary retention) will be made.

On the next day, the subject will return in a fasting condition for the satiety test. The methods are similar to those of Tack et al and Chial et al. The subject will take their study medication. After 30 minutes, the subject will drink the nutrient drink Ensure at a rate of 100 ml every 5 minutes until the subject feels completely full. After each 100 ml, symptoms will be monitored, scoring the symptoms of satiety (fullness), nausea, abdominal discomfort, and bloating on a scale of (0-5). The volume of Ensure consumed by the subject will be recorded.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220844

Contacts
Contact: Henry P Parkman, MD 1-215-707-3431 henry.parkman@temple.edu

Locations
United States, Pennsylvania
Temple University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P Parkman, MD    215-707-3431    henry.parkman@temple.edu   
Principal Investigator: Henry P Parkman, MD         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Henry P Parkman, MD Temple University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220844     History of Changes
Other Study ID Numbers: TU4255
Study First Received: September 19, 2005
Last Updated: February 8, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Amitriptyline
Antidepressive Agents, Tricyclic
Desipramine
Antidepressive Agents
Amitriptyline, perphenazine drug combination
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014