Resumen

El propósito de este estudio es evaluar la seguridad y tolerabilidad a largo plazo de aticaprant administrado como terapia adyuvante a un antidepresivo actual (inhibidor selectivo de la recaptación de serotonina [ISRS] o inhibidor de la recaptación de serotonina y noradrenalina [IRSN]) en todos los participantes con trastorno depresivo mayor (TDM).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 74 YearsSexo: ALL

Criterios de inclusión

Transferred-entry participants:
Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent study
Direct-entry participants:
Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression
Must be an outpatient at open-label treatment phase baseline
Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)
Direct-entry and Transferred-entry Participants:
Participants should not take any prohibited medication or food supplements

Criterios de exclusión

Transferred-entry Participants:
Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments
Direct-entry Participants:
Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients

Ubicaciones

INSA Instituto de Neurociencias San Agustín

Buenos Aires, Argentina

STAT Research S A

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

CENydET - Centro Neurobiologico y de Stress Traumatico

Ciudad Autonoma Buenos Aires, Argentina

CEN Consultorios Especializados en Neurociencias

Córdoba, Argentina

Fundacion Lennox

Córdoba, Argentina

Instituto Medico DAMIC

Córdoba, Argentina

Centro Medico Luquez

Córdoba, Argentina

CENPIA

La Plata, Argentina

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, Argentina

Resolution

Mendoza, Argentina

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, Argentina

Instituto Medico de La Fundacion Estudios Clinicos

Rosario, Argentina

Clinica Mayo de UMCB

San Miguel de Tucumán, Argentina

Clinica El Jardin

Santiago del Estero, Argentina

Estudio abierto de seguridad y eficacia a largo plazo de aticaprant como terapia adyuvante en participantes adultos y ancianos con trastorno depresivo mayor (TDM)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Aticaprant

Ubicaciones

INSA Instituto de Neurociencias San Agustín

STAT Research S A

CIPREC

Hospital Italiano de Buenos Aires

CENydET - Centro Neurobiologico y de Stress Traumatico

CEN Consultorios Especializados en Neurociencias

Fundacion Lennox

Instituto Medico DAMIC

Centro Medico Luquez

CENPIA

Clinica Privada de Salud Mental Santa Teresa de Ávila

Resolution

C I A P Centro de investigacion y Asistencia en Psiquiatria

Instituto Medico de La Fundacion Estudios Clinicos

Clinica Mayo de UMCB

Clinica El Jardin

Patrocinadores