Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

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

The registry classes the interventions as drug and other.

More on the Plan

Introduction 1.1 Oxytocin (OT) OT is a nine-amino acid neuropeptide synthesized in the magnocellular neurons of the paraventricular (PVN) and supraoptic nuclei (SON) of the hypothalamus, and released by the pituitary gland (Meyer-Lindenberg, Domes, Kirsch, \& Heinrichs, 2011).

OT has both peripheral and central effects, and serves as a neurotransmitter, a neuromodulator and a hormone (see reviews in de Bono, 2003; Skuse \& Gallagher, 2009).

Peripherally, it is released from the posterior pituitary into the bloodstream where it functions as a hormone and influences bodily functions, such as regulating uterine contractions during labor and lactation (Keverne \& Kendrick, 1992).

Centrally, through direct axonal release from the PVN, OT acts as a neurotransmitter projecting to various critical brain structures rich with OT receptors such as the hippocampus, amygdala, striatum, and nucleus accumbens (Landgraf \& Neumann, 2004;Macdonald \& Macdonald, 2010; Ross \& Young, 2009).

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Diagnosis: Transdiagnostic (e.g. depression, anxiety disorders, OCD, personality disorders, PTSD, etc.). Expected length of hospitalization of at least 4 weeks. A physical and psychiatric evaluation will be conducted in admission to hospital.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: pregnancy (bhcg levels will be tested in fertile-aged female patients); patients undergoing ect; substance abuse comorbidity (not including cigarette smoking).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2018-06-01 with completion listed for 2025-06.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Depression and Anxiety Symptoms.

It also tracked 1 secondary outcome, for example Change in Therapeutic Working Alliance.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 120 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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