An investigation of the effects of intranasal oxytocin spray on socio-emotional brain regions in ageing in healthy adults.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001148561

Enrollment

100

Registered

2015-10-28

Start date

2015-10-20

Completion date

2019-09-30

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The overall aim of the current study is to examine social and emotional brain regions involved in healthy ageing using a double-blind placebo controlled intranasal oxytocin design and MRI techniques involving fMRI.

Interventions

Two acute treatment (24 IU each) conditions including; a) intranasal placebo, and b) intranasal oxytocin (Syntocinon, Novartis, Switzerland). The two treatment conditions will be separated by a minimum of 1 week (washout period). The nasal sprays will be administered 50 mins prior to the functional magnetic resonance (fMRI) protocol using a standard supervised dosage procedure that involves 3 sprays in each the left or right nostril (6 sprays total). The fMRI protocol will be 20mins in duration and involve showing participants a brief task involving pictures of human faces expressing different emotions. The MRI protocol will also involve taking structural, resting state images of the brain while the participant is not engaged in a task.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

Right-handed; non-smoker and no drug/alcohol abuse; medication free; no neurological disorders, and no metal objects present in body (or which can't be removed or which is not MRI safe).

Exclusion criteria

Clinically significant medical or neurological condition, significant head injury (or loss of consciousness from longer than 5 mins), presence of ferrous-containing metals within the body, inability to tolerate small enclosed spaces without anxiety.

Outcome results