Authorised Therapeutic use (Phase IV) Borderline Personality Disorder.

Randomized Clinical Trial on Oxytocin and Self-Compassion Training in Borderline Personality Disorder

EU CTIS ID: 2024-515589-15-00

What this study is testing

Evaluate the therapeutic potential in Borderline Personality Disorder (BPD) of the combination of intranasal oxytocin together with Self-Compassion Training (SCT) to facilitate the therapeutic process.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Diagnosis of Borderline Personality Disorder (BPD) according to two semi-structured interviews (SCID-II and DIB-R).
  • Ages between 18 and 50 years old.
  • Stability of pharmacological treatment during the intervention.
  • Previous treatment for Borderline Personality Disorder (BPD) with standard Dialectical Behavioral Therapy (DBT) or Dialectical Behavioral Therapy (DBT) skills training.
  • High levels of self-criticism. Scores on the Inadequate Self (IS) subscale of the FSCRS-SF > 12.

You likely can't join if

  • Comorbidity with: schizophrenia, psychosis, bipolar disorder, ongoing major depressive disorder, substance dependence, organic brain disease or mental retardation according to medical examination and clinical evaluation by SCID-I.
  • History of severe endocrinological disorders.
  • History of Epilepsy, Renal Insufficiency or Heart Failure.
  • Start another psychotherapy treatment in parallel.
  • Potentially fertile women unwilling to take contraceptive measures (oral contraception, intrauterine device, partner vasectomy, tubal ligation or sexual abstinence) during the entire study period.
  • Gestational desire or pregnancy planning during the study.
See the full eligibility criteria
Who can join
  • Diagnosis of Borderline Personality Disorder (BPD) according to two semi-structured interviews (SCID-II and DIB-R).
  • Ages between 18 and 50 years old.
  • Stability of pharmacological treatment during the intervention.
  • Previous treatment for Borderline Personality Disorder (BPD) with standard Dialectical Behavioral Therapy (DBT) or Dialectical Behavioral Therapy (DBT) skills training.
  • High levels of self-criticism. Scores on the Inadequate Self (IS) subscale of the FSCRS-SF > 12.
What rules you out
  • Comorbidity with: schizophrenia, psychosis, bipolar disorder, ongoing major depressive disorder, substance dependence, organic brain disease or mental retardation according to medical examination and clinical evaluation by SCID-I.
  • History of severe endocrinological disorders.
  • History of Epilepsy, Renal Insufficiency or Heart Failure.
  • Start another psychotherapy treatment in parallel.
  • Potentially fertile women unwilling to take contraceptive measures (oral contraception, intrauterine device, partner vasectomy, tubal ligation or sexual abstinence) during the entire study period.
  • Gestational desire or pregnancy planning during the study.
  • Being pregnant or breastfeeding during the study.
  • Being under medical treatment incompatible with the administration of oxytocin.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.