Oxytocin and Social Cognition in Frontotemporal Dementia

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

These cognitive functions are thought to be critical for appropriate social behavioural regulation (Blair, 2003).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 30 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinical diagnosis of probable Frontotemporal Dementia or Pick's disease. Caregiver available to participate in all study visits.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: severe language or memory deficits that preclude completion of the cognitive tasks; females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause); uncontrolled hypertension.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-09 with completion listed for 2010-11.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Performance on Emotion Recognition Tasks (time frame: Day of treatment).

It also tracked 2 secondary outcomes, for example Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours and Side effects.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.