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Oxytocin Plus Self-compassion Training in Borderline Personality Disorder

Plain-language guide to NCT07551882: phase 2 randomized trial of Oxytocin, 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07551882
Phase
phase 2
Status
recruiting participants
Start
2024-01-10
Completion (planned or actual)
2026-06-01
Participants
80 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Self-compassion Training (SCT) Plus Intranasal Oxytocin; Self-compassion Training (SCT) Plus Intranasal Placebo
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Oxytocin.

Background: Borderline personality disorder (BPD) is a frequentand serious psychiatric disorder characterized by a persistent pattern of instability in relationships, affect and self-image.

It had two arms (groups): Self-compassion training (SCT) plus intranasal oxytocin (experimental) and Self-compassion training (SCT) plus intranasal placebo (placebo comparator).

Self-Compassion training (SCT) consists of a 5 sessions of self-compassion meditation trainning plus intranasal oxytocin.

Self-Compassion training (SCT) consists in 5 sessions of self-compassion meditation training plus Intranasal Placebo.

The registry classes the interventions as behavioral and drug.

More on the Plan

Self-criticism, self-compassion, clinical and wellness measures will be evalutated as outcomes.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Diagnosis of Borderline Personality Disorder (BPD) according to two semi-structured interviews: the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) and the Revised Diagnostic Interview for Borderlines (DIB-R). Aged between 18 and 50 years, inclusive. Previous treatment for BPD, specifically Standard Dialectical Behavior Therapy (DBT) or DBT Skills Training. High levels of self-criticism, defined as scores \> 12 on the Inadequate Self (IS) subscale of the Forms of Self-Criticizing/Attacking \& Self-Reassuring Scale - Short Form (FSCRS-SF).

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: history of severe endocrine disorders; history of medical conditions, specifically: epilepsy, renal insufficiency (kidney failure), or heart failure; concurrent participation in any other psychotherapy or psychological treatment during the study period.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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 and investigator.

It started in 2024-01-10 with completion listed for 2026-06-01.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Self Compassion Scale Short Form (SCS-SF) (time frame: 1 month).

It also tracked 5 secondary outcomes, for example Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale-Short Form (FSCRS-SF), Borderline Symptoms List-23 (BSL-23), Satisfaction with life scale (SWLS), Pemberton Happiness Index (PHI) and OMS WHO-QOL-BREF( WHOQOL-Group, 1998).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 80 people.

It is still recruiting; 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.