Dyad Oxytocin Study (DOS)

What Was Tested

The trial (phase 1) is built around Oxytocin.

The purpose of the investigators proposed study is twofold: 1) To investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic system positively influences these family interactions.

It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).

Saline Nasal Spray.

The registry classes the interventions as drug and other.

Who Took Part

104 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Inclusion criteria for caregiver of patients with schizophrenia, patients with autism spectrum disorder, and healthy controls:. Age between 18 and 75 years old. Between the ages of 14 and 45. Patients must have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis- Not Otherwise Specified (NOS). Patients must be clinically stable.

The full record lists 15 inclusion and 9 exclusion criteria; among the exclusions: female caregivers that state that they are pregnant or have a positive urine pregnancy test; exclusion criteria for healthy controls:; healthy controls with history of psychiatric or neurological illness.

How the Study Was Run

Design: randomized, crossover and double-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 and investigator.

It started in 2011-04 with completion listed for 2017-10.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Change in Negative Expressed Emotion (time frame: Continuously for 4 hours after drug adimistration).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 104 people.

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.