Oxytocin as Adjunctive Treatment of Schizophrenia

What Was Tested

This registered phase 2 trial tested Oxytocin.

The focus of the current project is to advance their understanding of the effects of oxytocin (OT) on components of social cognition in schizophrenia (SCZ).

Social deficits are a crucial aspect of the functional impairments that limit the rehabilitation of patients with SCZ.

It had three arms (groups): Oxytocin (experimental), Placebo (placebo comparator) and Healthy Controls (other).

Participants who have no psychiatric diagnosis and will be controls for this project. These controls will not receive oxytocin or placebo. They will only receive psychiatric screening interview, MATRICS Consensus Cognitive Battery (MCCB) assessment, urine drug screen, vision testing, and the three social cognition tasks.

The registry classes the interventions as drug and other.

More on the Plan

Specific Aim 1: Administer OT intranasally vs. placebo in a parallel group double-blind design to 40 deficit syndrome SCZ subjects.

Evaluate the salience of social cues by the measurement of visual scan paths during gaze at pictures of faces. 2.

Evaluate sensitivity to social reward by means of a computerized social reward ball-tossing task that assays social interactions in response to social reward. 3.

Evaluate social cognition by means of testing the ability to correctly identify emotion from pictures of faces (Facial Emotion Identification Test, FEIT).

Who Took Part

Enrollment: 39 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: Subjects must be between 18 and 65 years old at the time of study screening. Subjects must have been maintained on a stable treatment of antipsychotics and/or other concomitant psychotropic treatment for at least 6 weeks prior to consent.

The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: female sex; history of bipolar disorder; active substance dependence within the prior 30 days (cigarette smoking is allowed).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

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 2013-03 with completion listed for 2017-03-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Eye Tracking: Fixation Count (time frame: Day 1). Eye Tracking: Dwell Duration Time (time frame: Day 1). Social Reward Ball-tossing Task (time frame: Day 1).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 39 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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