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oxytocin other rct 2023-06-30 ClinicalTrials

Oxytocin Nasal Spray Trial Investigates Psychotherapy Boost for Eating Disorders

The Moderating Role of Baseline Oxytocin on Its Psychotherapy-facilitating Effects Among Patients With Eating Disorders

Background

Eating disorders are complex mental health conditions with significant morbidity and mortality, often requiring intensive psychotherapy. While psychotherapy is effective, treatment outcomes can vary, and some patients struggle with engagement or progress. This Phase 1 clinical trial aims to understand how baseline oxytocin levels might influence the effectiveness of intranasal oxytocin as an adjunct to psychotherapy in patients with these challenging conditions.

Study Design

Population
Patients with eating disorders; n not specified.
Intervention
Intranasal oxytocin 24 IU, duration not specified, as an adjunct to psychotherapy.
Comparator
No comparator (Phase 1 trial).
Outcome
Safety, tolerability, and potential efficacy signals of intranasal oxytocin as an adjunct to psychotherapy, and how baseline oxytocin levels moderate its effects.

Results

As this is an ongoing Phase 1 clinical trial, no specific results or findings are available yet. The study's primary objective is to investigate the potential of intranasal oxytocin to enhance psychotherapy outcomes in patients with eating disorders. Researchers aim to determine how baseline oxytocin levels might moderate the psychotherapy-facilitating effects of exogenous oxytocin administration, hypothesizing that individuals with lower endogenous oxytocin may benefit more from the 24 IU dose. This trial seeks to gather crucial preliminary data on the safety, tolerability, and potential efficacy signals of this novel adjunctive treatment approach, with results expected after its estimated completion in April 2025.

Why It Matters

This research is critical for identifying novel strategies to improve outcomes for individuals suffering from eating disorders, which often have high relapse rates and incomplete recovery. If successful, this study could pave the way for personalized treatment approaches, where oxytocin administration is tailored based on a patient's baseline neurobiological profile. This could lead to the development of oxytocin as a targeted adjunctive therapy to enhance psychotherapy efficacy, potentially moving towards Phase 2 human trials. Ultimately, this could significantly improve the quality of life and recovery rates for patients.


oxytocin other dose mentioned safety data present
Source: clinicaltrials:NCT05865288 · Ingested 2026-04-27 · Digest: gemini-2.5-flash