Adult Study Oxytocin - Behavioral

What Was Tested

The trial (early phase 1) is built around Oxytocin.

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia and other psychotic disorders.

Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.

Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.

It had two arms (groups): Oxytocin (experimental) and Saline Nasal Spray (placebo comparator).

Placebo Comparator.

The registry classes the interventions as drug.

More on the Plan

Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires.

The study will be conducted with the same study arms and study interventions as in the proposed parent study.

For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.

Who Took Part

Enrollment: 324 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: 18 to 45 years of age. Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder with psychotic features, or brief psychotic disorder. No or at most only minor changes to medications in the past week. Able to use nasal spray. Must be capable of providing informed consent.

The full record lists 13 inclusion and 13 exclusion criteria; among the exclusions: active substance and alcohol use disorder in the past month as determined by the dsm-5 criteria, not including cannabis use disorder; subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy); hearing deficits.

How the Study Was Run

The set-up was randomized, crossover 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.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-10 with completion listed for 2019-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Social Cognition Task Performance (time frame: Through study completion, 2-3 weeks).

It also tracked 2 secondary outcomes, for example Physiological Measurements and Questionnaire.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 324 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.