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The relation between free serotonin in plasma, serotonin in platelets, and the type of serotonin transporter in carcinoid tumor patients, patients using SSRI, and healthy controls.


- candidate number12224
- NTR NumberNTR3393
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-apr-2012
- Secondary IDs2009/171 METC UMCG
- Public TitleThe relation between free serotonin in plasma, serotonin in platelets, and the type of serotonin transporter in carcinoid tumor patients, patients using SSRI, and healthy controls.
- Scientific TitleThe relation between free serotonin in plasma, serotonin in platelets, and the genotype of the serotonin transporter in carcinoid tumor patients, patients using selective serotonin reuptake inhibitors, and healthy controls.
- ACRONYMSERT
- hypothesis1. The concentrations serotonin and dopamine are different between carcinoid tumor patients, patients using SSRI, and healthy controls;
2. The concentration free serotonin in plasma, and the ratio free serotonin/serotonin in platelets is determined by the genotype of the serotonin transporter.
- Healt Condition(s) or Problem(s) studiedCarcinoid tumour, SSRI, Fresh frozen plasma, Platelets, Serotonin transporter
- Inclusion criteriaEthics:
1. Approval of the METC UMCG;
2. Written informed consent.

Participants:
1. Healthy men or women;
2. Patients with a metastasized carcinoid tumor, that produces serotonin;
3. Patients with a depression or anxiety disorder, which use selective serotonin reuptake inhibitors:
A. The diagnosis is based on the judgement of the patient's current doctor;
B. The depression/anxiety disorder can be present or in remission;
C. Treatment with SSRI should be at least 6 weeks, and the dose should be suitable (citalopram 20mg; escitalopram 10mg; fluvoxamine 100mg; fluoxetine 20mg; paroxetine 20mg; sertraline 50mg).
- Exclusion criteria1. The use of medication that interferes with the serotonin metabolism or serotonin reuptake (exception: use of SSRI in patients with depression/anxiety disorder), for example aspirin, psychofarmaca (other than SSRI (TCA, MAO-inhibitors, mirtazapine, bupropion, venlafaxine, duloxetine), anxiolytics, antipsychotics, and anticonvulsants;
2. Drug abuse (8 weeks prior to inclusion);
3. Alcohol abuse (8 weeks prior to inclusion: females: >14 glasses a week, males: >21 glasses a week);
4. Consumption of walnuts or bananas 48 hours prior to obtaining of blood sample.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2011
- planned closingdate1-jun-2014
- Target number of participants105
- InterventionsNo intervention: At one time point 24mL EDTA blood will be obtained from the patient.
- Primary outcomeAnalyzing whether there is a difference in the concentration dopamine and serotonin in the plasma and platelets of carcinoid tumor patients, patients using SSRI, and healthy controls.
- Secondary outcomeAnalyzing whether the concentration free serotonin in plasma, and the ratio free serotonin/serotonin in platelets is determined by the genotype of the serotonin transporter.
- TimepointsThis is a cross-sectional study: At one time point 24mL EDTA blood will be obtained.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. W.H.A. Jong, de
- CONTACT for SCIENTIFIC QUERIESDr. W.H.A. Jong, de
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryIntroduction:
Serotonin is a neurotransmitter that is responsible for several physiological processes in the body, e.g. muscle contraction, blood pressure regulation, and peripheral en central neurotransmission. The serotonin transporter (SERT) is the most important regulator of the concentration free serotonin in the plasma, because it transports serotonin from the plasma into platelets, enterochromaffin cells, and neurons, where serotonin is stored and metabolized. Serotonin also has a role in depression. Part of the patients with a carcinoid tumor produce surplus of serotonin. To investigate the correlation between free plasma serotonin and its effect on the cardiovascular system, gastrointestinal tracts, and the lungs, free serotonin in plasma has to be determined. Until now, no analytic method was available to reliably determine this concentration.

Aim:
1. To analyze the concentration dopamine and serotonin in the plasma and platelets of carcinoid tumor patients, patients using SSRI, and healthy controls;
2. To analyze the influence of the genotype of the serotonin transporter on the concentration free serotonin in plasma, and the ratio free serotonin/serotonin in platelets.

Methods:
This is a cross-sectional study. Of 30 carcinoid tumor patients, 70 patients using SSRI, and 5 healthy controls 24mL EDTA blood will be obtained. Dopamine, and serotonin in plasma and platelets, and the genotype of the serotonin transporter will be determined.
- Main changes (audit trail)
- RECORD10-apr-2012 - 26-apr-2012


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