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    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2022-000439-22
    Sponsor's Protocol Code Number:67953964MDD3001_VENTURA-1
    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:2022-10-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-000439-22
    A.3Full title of the trial
    A Randomized, Double-blind, Multicenter, Parallel-Group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-Severe Anhedonia and Inadequate Response to Current Antidepressant Therapy
    Un estudio aleatorizado, doble ciego, multicéntrico, de grupos paralelos y controlado con placebo para evaluar la eficacia, la seguridad y la tolerabilidad de aticaprant 10 mg como tratamiento complementario en participantes adultos con trastorno depresivo mayor (TDM) con anhedonia moderada a grave y una respuesta insuficiente al tratamiento antidepresivo actual.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effectiveness of aticaprant as an add on treatment in patients with depression who have not responded sufficiently to their current antidepressant.
    Un estudio para evaluar la eficacia de aticaprant como tratamiento complementario en participantes adultos con trastorno depresivo mayor (TDM) con una respuesta insuficiente al tratamiento antidepresivo actual.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number67953964MDD3001_VENTURA-1
    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 SponsorJanssen-Cilag International NV
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV- Clinical registry group- Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.4Telephone number+34913238182
    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 No
    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.3.1Product nameAticaprant
    D.3.2Product code JNJ-67953964
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAticaprant
    D.3.9.2Current sponsor codeJNJ-67953964
    D.3.9.4EV Substance CodeSUB198023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder (MDD)
    Trastorno Depresivo Mayor (TDM)
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of aticaprant 10 mg compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with MDD with moderate-to-severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with an SSRI or SNRI.
    Evaluar la eficacia de aticaprant 10 mg en comparación con placebo como tratamiento complementario a un antidepresivo en la mejoría de los síntomas depresivos en participantes con TDM con anhedonia de moderada a grave (ANH+) que han tenido una respuesta insuficiente al tratamiento antidepresivo actual con ISRS o un IRSN.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of adjunctive aticaprant 10 mg compared with placebo in improving anhedonia in adult participants with MDD ANH+ who have had an inadequate response to current antidepressant therapy with an SSRI or SNRI
    • Evaluar la eficacia de aticaprant 10 mg en comparación con placebo como tratamiento complementario en la mejoría de la anhedonia en participantes adultos con TDM ANH+ que han tenido una respuesta insuficiente al tratamiento antidepresivo actual con un ISRS o un IRSN.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, aged 18 to 74 years of age, inclusive.
    - Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and baseline
    - Be medically stable on the basis of clinical laboratory tests performed at screening
    - Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age.
    - Have had an inadequate response to at least 1 but no more than 3 antidepressants, administered at an adequate dose (therapeutic dose per MHH ATRQ) and duration (at least 6 weeks) in the current episode of depression.
    - Is currently receiving and tolerating well a SSRI/SNRI for depressive symptoms at screening, at a stable dose for at least 6 weeks
    - Have a HDRS-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessments
    - Hombre o mujer, de 18 a 74 años de edad, ambos inclusive.
    - Estar médicamente estable sobre la base del examen físico, el historial médico, los signos vitales y el ECG de 12 derivaciones realizado en la selección y al inicio.
    - Estar médicamente estable sobre la base de las pruebas de laboratorio clínico realizadas en la selección
    - Cumplir con los criterios diagnósticos del DSM-5 para TDM recurrente o de episodio único, sin características psicóticas. Los participantes de 65 años o más deben haber tenido el primer inicio de depresión antes de los 55 años.
    - Haber tenido una respuesta inadecuada a al menos 1 pero no más de 3 antidepresivos, administrados a una dosis adecuada (dosis terapéutica por MHH ATRQ) y duración (al menos 6 semanas) en el episodio actual de depresión.
    E.4Principal exclusion criteria
    - Participant has lack of clinically meaningful improvement (≤25% improvement) to the current SSRI/SNRI (ie, the one presumed to be continued in the treatment phase) assessed using the MGH ATRQ.
    - Has one or more of the following diagnoses:
    *A DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years)of any of the following: panic disorder, generalized anxiety disorder, social anxiety disorder, specific phobia.
    * current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder, post-traumatic stress disorder, anorexia nervosa, bulimia nervosa
    * A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or MDD with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, narcissistic personality disorders, somatoform disorders.
    - Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy.
    - Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
    - Has within the last 5 years received any prior antidepressant treatment with ketamine/esketamine, electroconvulsive therapy (i.e, at least 7 treatments), vagal nerve stimulation, or a deep brain stimulation device
    - Has a current homicidal ideation/intent, per the investigator’s clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase
    El participante carece de una mejoría clínicamente significativa (mejora ≤25 %) con respecto al ISRS/IRSN actual (es decir, el que se supone que continuará en la fase de tratamiento) evaluado mediante el MGH ATRQ.
    - Tiene uno o más de los siguientes diagnósticos:
    *Un diagnóstico DSM-5 (que ha sido el enfoque principal del tratamiento psiquiátrico en los últimos 2 años) de cualquiera de los siguientes: trastorno de pánico, trastorno de ansiedad generalizada, trastorno de ansiedad social, fobia específica.
    * diagnóstico actual (en el último año) DSM-5 de: trastorno obsesivo-compulsivo, trastorno de estrés postraumático, anorexia nerviosa, bulimia nerviosa
    * Un diagnóstico DSM-5 actual o previo (de por vida) de: un trastorno psicótico o TDM con características psicóticas, trastornos bipolares o relacionados, discapacidad intelectual, trastorno del espectro autista, trastorno límite de la personalidad, trastorno antisocial de la personalidad, trastorno histriónico de la personalidad, trastornos narcisistas de la personalidad, trastornos somatomorfos.
    - Tiene antecedentes o evidencia de incumplimiento clínicamente significativo con la terapia antidepresiva actual.
    - Tiene antecedentes de trastorno por consumo de sustancias de moderado a grave, incluido el trastorno por consumo de alcohol según los criterios del DSM-5 en los 6 meses anteriores a la selección.
    - Ha recibido en los últimos 5 años algún tratamiento antidepresivo previo con ketamina/s-ketamina, terapia electroconvulsiva (es decir, al menos 7 tratamientos), estimulación del nervio vago o un dispositivo de estimulación cerebral profunda
    - Tiene una idea/intención homicida actual, según el juicio clínico del investigador, o tiene ideación suicida con alguna intención de actuar dentro de los 3 meses anteriores al inicio de la fase de selección.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
    Cambio desde el inicio (es detercir, día 1 antes de la aleatorización y, en adelante, denominado “inicio”) hasta el día 43 en la puntuación total de la escala de valoración de la depresión de Montgomery-Åsberg (Montgomery-Åsberg Depression Rating Scale, MADRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Day 15, Day 29, Day 43
    Día 1, Día 15, Día 29, Día 43
    E.5.2Secondary end point(s)
    Change from baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) total score.
    Cambio con respecto al inicio hasta el día 43 en la puntuación total de la Escala de valoración de la anhedonia dimensional (DARS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 15, Day 29, Day 43
    Día 1, Día 15, Día 29, Día 43
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of study is considered as the last scheduled study assessment shown in the schedule of assessments for the last participant in the study
    Se considera que el ensayo termina en la última visita que aparece en el calendario de actividades del último paciente en el ensayo.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 430
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 538
    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)
    Participants who have completed the Double Blind Treatment Phase (Day 43) may be eligible to participate in a separate 52 week open-label long-term safety study 67953964MDD3003.
    Los participantes que hayan completado la fase de tratamiento DC (día 43) y que cumplan con el tratamiento del estudio pueden ser aptos para participar en el estudio de seguridad a largo plazo abierto independiente de 52 semanas 67953964MDD3003
    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 Decision2023-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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