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    EudraCT Number:2022-003670-22
    Sponsor's Protocol Code Number:IIBSP-OXI-2022-124
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-09
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-003670-22
    A.3Full title of the trial
    Controlled and randomized clinical trial to evaluate the efficacy of the combination of oxytocin plus self-compassion training in patients with Borderline Personality Disorder
    Ensayo clínico controlado y aleatorizado para evaluar la eficacia de la combinación de oxitocina más entrenamiento en autocompasión en pacientes con Trastorno Límite de Personalidad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy of the combination of oxytocin plus self-compassion training in patients with Borderline Personality Disorder
    Estudio para evaluar la eficacia de la combinación de oxitocina más entrenamiento en autocompasión en pacientes con Trastorno Límite de Personalidad
    A.4.1Sponsor's protocol code numberIIBSP-OXI-2022-124
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstituto de Salud Carlos III
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca H. Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quinti 77-79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.4Telephone number+34935537636
    B.5.5Fax number+34935537856
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Syntocinon
    D. of the Marketing Authorisation holderNovartis Farma - Produtos Farmacêuticos, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxytocin
    D.3.9.1CAS number 50-56-6
    D.3.9.4EV Substance CodeSUB09580MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray, solution
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Borderline personality disorder
    Trastorno Límite de la Personalidad
    E.1.1.1Medical condition in easily understood language
    Borderline personality disorder
    Trastorno Límite de la Personalidad
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To study the efficacy of the combined intervention: self compassion training (EA) + intranasal oxytocin (OI) aimed at increasing self-compassion and self-validation, in patients with borderline personality disorder (BPD) compared to the condition EA + placebo (PBO)
    -Estudiar la eficacia de la intervención combinada de Entrenamiento en autocompasión (EA) + Oxitocina Intranasal (OI), orientada al incremento de la autocompasión y autovalidación, en pacientes con Trastorno Límite Personalidad (TLP) en comparación con la condición EA + placebo (PBO)
    E.2.2Secondary objectives of the trial
    - To study the effect of the combination (EA + LE) on the symptoms of BPD.
    - To explore the impact of (EA + OI) on the regulation of anger in BPD patients.
    - Explore the effect of (EA + OI) on the measure of judgment and self-criticism.
    - Explore the effect of (EA + LE) on the functionality of BPD patients.
    - To explore the effect of (EA + LE) on the psychological well-being of BPD patients assigned to this intervention.
    - Estudiar el efecto de la combinación (EA + OI) en la sintomatología propia del TLP.
    - Explorar el impacto del (EA + OI) en la regulación de la rabia de los pacientes TLP.
    - Explorar el efecto del (EA + OI) en la medida de juicio y autocrítica.
    - Explorar el efecto del (EA + OI) en la funcionalidad de los pacientes TLP.
    - Explorar el efecto del (EA + OI) en el bienestar psicológico de los pacientes TLP asignados a esta intervención.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Diagnosis of BPD according to two semi-structured interviews (SCID-II and DIB-R).
    2) Ages between 18 and 50 years.
    3) Stability in the pharmacological treatment during the performance of the intervention.
    4) Having undergone previous treatment for BPD with standard TDC or TDC skills training.
    1) Diagnóstico de TLP según dos entrevistas semiestructuradas.
    2) Edades entre los 18 y 50 años.
    3) Estabilidad en el tratamiento farmacológico durante la realización de la intervención.
    4) Haber realizado un tratamiento previo para TLP con TDC estándar o entrenamiento de habilidades de la TDC.
    E.4Principal exclusion criteria
    1) Present comorbidity with: schizophrenia, psychosis, bipolar disorder, ongoing major depressive disorder, substance dependence, organic brain diseases, or mental retardation according to medical examination and clinical evaluation using SCID-I.
    2) Present a history of serious endocrinological disorders.
    3) Start with another psychotherapy treatment in parallel.
    4) Not being in accepted contraceptive treatment.
    5) Pregnancy desire or pregnancy planning during the study. The use of accepted contraceptive method will be required except hormonal treatment.
    6) Being pregnant or breastfeeding during the study.
    7) Being in medical treatment incompatible with the administration of oxytocin.
    1) Presentar comorbilidad con: esquizofrenia, psicosis, trastorno bipolar, trastorno depresivo mayor en curso, dependencia de sustancias, enfermedades orgánicas cerebrales o retraso mental según exploración médica y evaluación clínica mediante SCID-I.
    2) Presentar antecedentes de trastornos endocrinológicos graves.
    3) Comenzar con otro tratamiento en psicoterapia de forma paralela.
    4) No estar en tratamiento anticonceptivo aceptado.
    5) Deseo gestacional ni planificación del embarazo durante la realización del estudio. Se requerirá el uso de método anticonceptivo aceptado excepto el tratamiento hormonal.
    6) Estar embarazada o en lactancia materna durante la realización del estudio.
    7) Estar en tratamiento médico incompatible con la administración de oxitocina.
    E.5 End points
    E.5.1Primary end point(s)
    Self-pity/self-invalidation measures: Self Compassion Scale Short Form; Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale.
    Medidas de autocompasión/autoinvalidación: Self Compassion Scale Short Form; Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 weeks
    5 semanas
    E.5.2Secondary end point(s)
    Symptoms typical of BPD through the Borderline Symptoms List-23; Rabies symptomatology through the STAXI; Satisfaction with life: Satisfaction with life scale; Additional measures of well-being: Pemberton Happiness Index; Functionality measures: WHO quality of life scale WHO-QOL-BREF.
    Sintomatología propia de TLP a través de la Borderline Symptoms List-23; Sintomatología de rabia a través del STAXI; Satisfacción con la vida: Satisfaction with life scale; Medidas adicionales de bienestar: Índice de felicidad Pemberton Happiness Index; Medidas de funcionalidad: Escala de calidad de vida de la OMS WHO-QOL-BREF.
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 weeks
    5 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-19
    P. End of Trial
    P.End of Trial StatusOngoing
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