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van CCT (UK)

van CCT (UK)

Neural mechanisms of oxytocin

- candidate number4108
- NTR NumberNTR1454
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2008
- Secondary IDs 
- Public TitleNeural mechanisms of oxytocin
- Scientific TitleNeural mechanisms of oxytocin in human social - emotional behaviour
- ACRONYMNeural mechanisms of OT
- hypothesisOxytocin has effect on neural areas involved in human social emotional functioning
- Healt Condition(s) or Problem(s) studiedOxytocin, Behaviour, Emotions
- Inclusion criteria1. Good health
2. Age between 18 and 30
3. Normal or corrected to normal vision
4. Right-handedness
- Exclusion criteria1. Oversensitivity for OT or carrier
2. Use of psychotropic medication, or of recreational drugs over a period of two weeks prior to each experiment, and no use of alcohol within the last 24 hours before each measurement.
3. Habitual smoking
4. History of psychiatric treatment or current psychiatric treatment
5. History of neurological treatment or current neurological treatment
6. History of endocrinological treatment or current endocrinological treatment
7. Irremovable ferrous objects in or around the body (e.g. pacemaker, stents, splinters)
8. History of closed head injury
9. History of epilepsy
10. Claustrophobia
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate1-jan-2010
- Target number of participants20
- InterventionsParticipants will self-administer 24 IU OT nasal spray. This nasal spray contains a synthetic version of OT which is identical to the human pituitary version of OT under the registered name Syntocinon. The placebo condition will consist of the same nasal administration without the active ingredient OT. Nasal spray administration is an effective way of delivering OT in the central nervous system via the nasal mucous membrane, without substantial side effects (Born et al., 2002; Kosfeld et al., 2005).
- Primary outcomeDifferences in blood oxygen level dependent (BOLD) response between OT administration and placebo will be measured.
- Secondary outcome2 questionaires will be obtained
- Timepoints2 timepoints, 1 for placebo, 1 for experimental condition
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Utrecht University (UU)
- Funding
(Source(s) of Monetary or Material Support)
Utrecht University (UU)
- PublicationsN/A
- Brief summaryTo gain insight in the neurobiological mechanisms behind oxytocin effects on human social-emotional behaviour, the following study will investigate the neural mechanisms of human sociality combined with oxytocin administration. A within subjects, double-blind counterbalanced placebo controlled design will be used. One group of subjects will participate in both experimental and placebo condition. Procedures on both days are identical and consist of an explanation of the tasks to be performed, the administration (placebo or OT nasal spray) followed by an functional Megnatic Resonance Imaging scan during which 3 tasks investigating the neural mechanisms of social are to be performed and an anatomical scan is made. Contrasting task related Blood oxygen level dependent activation within the group between placebo and OT can show specific activation related to OT administration.
- Main changes (audit trail)
- RECORD24-sep-2008 - 6-okt-2008

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