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The dopaminergic system in patients with Functional Dyspepsia analyzed by an Alpha-Methyl-Para-Tyrosine (AMPT) challenge test and Single Photon Emission Computed Tomography (SPECT) imaging before and after treatment with amitriptyline.

The dopaminergic system in patients with Functional Dyspepsia analyzed by an Alpha-Methyl-Para-Tyrosine (AMPT) challenge test and Single Photon Emission Computed Tomography (SPECT) imaging before and after treatment with amitriptyline.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20110
Enrollment
60
Registered
2006-03-24
Start date
2006-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia (FD)

Interventions

1. Amitriptyline or placebo for the patient group (see the amitriptyline study)
2. Single Photon Emission Computed Tomography (SPECT) imaging with [123I] IBZM radioligand
3. Alpha-methyl-paratyrosine (AMPT, =metyrosine) challenge test. 2x 500 mg.

Sponsors

Academic Medical Center (AMC) amsterdam, department of gastroenterology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years; 2. Functional dyspepsia (NDI>25); 3. Take part in the amitriptyline study; 4. No effect of PPI or 3 months constantly the same doses; 5. No depression (ZUNG<50); 6. No medications which influence the intestine.

Exclusion criteria

Exclusion criteria: 1. Gastroduodenal surgery; 2. Reflux-like dyspepsia (Rome II criteria); 3. Use of antidepressivants; 4. Organic abnormalities; 5. Pregnancy; 6. Severe cardiac, renal, pulmonary, hepatic or systemic diseases. Hyperthyroidism, glaucoma and epilepsy; 7. Metal implantates.

Design outcomes

Primary

MeasureTime frame
To evaluate if patients with functional dyspepsia have a change in their dopaminergic system what leads to visceral hypersensitivity.

Secondary

MeasureTime frame
Has amitriptyline a positive effect on those changes in the dopaminergic system through reducing the stress?

Contacts

Public ContactG.E.E. Boeckxstaens

Academic Medical Center (AMC), Department of Gastroenterology, C2-328, P.O. Box 22660

g.e.boeckxstaens@amc.uva.nl+31 (0)20 5667375

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)