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

ISRCTN	ISRCTN63226989
DOI	https://doi.org/10.1186/ISRCTN63226989
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr G.E.E. Boeckxstaens
Scientific

Academic Medical Center (AMC)
Department of Gastroenterology
C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

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

Study design	Non-randomized, placebo-controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Patients (stress-sensitive) with functional dyspepsia have a change in their dopaminergic system, through chronic stress, which leads to visceral hypersensitivity and therefore dyspeptic symptoms.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Functional dyspepsia (FD)
Intervention	1. Amitriptyline or placebo for the patient group (see the amitriptyline study) 2. Single photon emission computed tomography (SPECT) imaging with radioligand (123I) iodobenzamide ([123I]IBZM) 3. Alpha-methyl-paratyrosine (AMPT/metyrosine) challenge test; 2 x 500 mg
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amitriptyline
Primary outcome measure	To evaluate if patients with functional dyspepsia have a change in their dopaminergic system that leads to visceral hypersensitivity
Secondary outcome measures	Has amitriptyline a positive effect on those changes in the dopaminergic system through reducing the stress?
Overall study start date	01/05/2006
Completion date	01/05/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Age 18-65 years 2. Functional dyspepsia (Nepean dyspepsia index [NDI] >25) 3. Take part in the amitriptyline study (ISRCTN76116512) 4. No effect on proton pump inhibitor (PPI), or a constant three-month dosage of PPI 5. No depression (Zung self-rating depression scale <50) 6. No medications which influence the intestine
Key exclusion criteria	1. Gastroduodenal surgery 2. Reflux-like dyspepsia (Rome II criteria) 3. Use of antidepressants 4. Organic abnormalities 5. Pregnancy 6. Severe cardiac, renal, pulmonary, hepatic or systemic diseases, hyperthyroidism, glaucoma and epilepsy 7. Metal implants
Date of first enrolment	01/05/2006
Date of final enrolment	01/05/2009

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)
University/education

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

"ROR"	https://ror.org/03t4gr691

University/education

Academic Medical Center (AMC)
Private sector organisation / Universities (academic only)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan