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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Psychological Phenomena [F02]

Trial duration

25 Jul 2024 → ongoing

Decision date (initial)

2024-07-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515589-15-00

EudraCT number

2022-003670-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 6

1. Assess the effect of the combination of intranasal oxytocin together with Self-Compassion Training (SCT) on the symptomatology of Borderline Personality Disorder (BPD).
2. Explore the impact of the combination of intranasal oxytocin together with Self-Compassion Training (SCT) on anger regulation in patients with Borderline Personality Disorder (BPD).
3. Explore the effect of the combination of intranasal oxytocin together with Self-Compassion Training (SCT) on the measure of judgment and self-criticism.
4. Explore the effect of the combination of intranasal oxytocin together with Self-Compassion Training (SCT) on the functionality of patients with Borderline Personality Disorder (BPD).
5. Explore the effect of the combination of intranasal oxytocin together with Self-Compassion Training (SCT) on the psychological well-being of patients with Borderline Personality Disorder (BPD) assigned to this intervention.
6. Exploring the effect of (EA + OI) on the quality of compassion meditation practice.

Conditions and MedDRA coding

Borderline Personality Disorder.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 8

1. 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.
2. History of severe endocrinological disorders.
3. History of Epilepsy, Renal Insufficiency or Heart Failure.
4. Start another psychotherapy treatment in parallel.
5. Potentially fertile women unwilling to take contraceptive measures (oral contraception, intrauterine device, partner vasectomy, tubal ligation or sexual abstinence) during the entire study period.
6. Gestational desire or pregnancy planning during the study.
7. Being pregnant or breastfeeding during the study.
8. Being under medical treatment incompatible with the administration of oxytocin.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Self-compassion/self-invalidation measures: Self Compassion Scale Short Form (SCS-SF; Neff, 2003; García-Campayo et al., 2014).

Secondary endpoints 6

1. Self-criticism/self-aggression and self-reassurance scale-short form (FSCRS-SF; Gilbert et al., 2004, Navarrete et al. 2021).
2. Symptomatology characteristic of Borderline Personality Disorder (BPD) through the Borderline Symptoms List-23 (BSL23; Bohus et al., 2009; Soler et al., 2013).
3. Rage symptomatology through lSTAXI (Miguel-Tobal et al., 2001).
4. Satisfaction with life: Satisfaction with life scale (SWLS; Diener et al., 1985; Atienza et al., 2000).
5. Additional measures of well-being: Pemberton Happiness Index (PHI; Hervás et al., 2013).
6. Measures of functionality: WHO Quality of Life Scale WHOQOL-BREF (WHOQOL-Group, 1998).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Sponsor organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Address

Calle Sant Quinti 77-79

City

Barcelona

Postcode

08041

Country

Spain

Scientific contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

UICEC Sant Pau

Public contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

UICEC Sant Pau

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications