← Human Trials & Peer-Reviewed Studies
The Effects of Oxytocin Administration to Patients and Therapists on Physiological Synchronization
Plain-language guide to NCT05432089: phase 2 randomized trial of Oxytocin, 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05432089
- Phase
- phase 2
- Status
- status unknown
- Start
- 2023-03-30
- Completion (planned or actual)
- 2026-07-01
- Participants
- 120 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Severe Mental Illness
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Oxytocin.
It had two arms (groups): one (experimental) and Placebo Group (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
Several studies have examined the influence of different types of substances on caretakers.
In other words, PS involves two individuals or more who mutually impact one another to the point of synchronizing, without necessary physical or visual contact.
Recently, Feldman (2020) has offered a model linking synchronized behavior, affiliative processes, and OT, arguing that these three components function in the service of a superordinate meaning system responsible for Human Resilience.
However, to the best of their knowledge, the hypothesis of OT as the mediating neuro-hormone of PS is yet to be tested.
Who Took Part
Enrollment: 120 planned participants were the target.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age above 18. Any type of psychiatric illness. Hospitalization in one of the inpatients wards.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: current severe psychotic episode; pregnancy according to self-report; psychologists, psychiatrists, and social workers, in different stages of seniority and training.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
The Oxytocin group and the comparison group ran side by side rather than switching.
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 2023-03-30 with completion listed for 2026-07-01.
It ran at 1 site in Israel.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: skin conductance synchrony (time frame: 1-2 weeks including 2 consecutive psychotherapy sessions).
It also tracked 3 secondary outcomes, for example working alliance, perceived empathic understanding and session impact.
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.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.