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 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands) |
| Funder | Academic Medical Center (AMC) |
- Submission date
- 07/06/2006
- Registration date
- 07/06/2006
- Last edited
- 07/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Contact information
Dr G.E.E. Boeckxstaens
Scientific
Scientific
Academic Medical Center (AMC)
Department of Gastroenterology
C2-328
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5667375 |
|---|---|
| g.e.boeckxstaens@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized, placebo-controlled trial |
| Secondary study design | Non randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amitriptyline |
| Primary outcome measure(s) |
To evaluate if patients with functional dyspepsia have a change in their dopaminergic system that leads to visceral hypersensitivity |
| Key secondary outcome measure(s) |
Has amitriptyline a positive effect on those changes in the dopaminergic system through reducing the stress? |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
