Resumen

El propósito de este estudio es evaluar las características sociodemográficas, relacionadas con la enfermedad y con el tratamiento, así como los patrones de tratamiento según el estándar de atención (SOC) en participantes con trastorno depresivo mayor (TDM) con anhedonia que presentan respuesta inadecuada a sus tratamientos antidepresivos actuales y son tratados de acuerdo con el estándar de atención.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 74 YearsSexo: ALL

Criterios de inclusión

Meets the diagnostic criteria for single episode or recurrent major depressive disorder (MDD) without psychotic features, according to either the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Is considered to suffer from a moderate or severe depressive syndrome, as defined by a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (\>=) 22 at entry
Is initiating or is planning to initiate a new add-on antidepressant treatment per local prescribing information to treat the current depressive episode. In the context of this observational study, a new add-on antidepressant treatment is considered any new pharmacological or non-pharmacological treatment that is prescribed in addition to the current antidepressant treatment, inclusive of an selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI or SNRI) with the intent to improve a participant's clinical depressive syndrome. Accordingly, any dose escalation of an antidepressant prescribed prior to baseline or the addition of any drug intended to increase the plasma-concentration of an antidepressant prescribed prior to baseline is not considered a new antidepressant treatment; In parallel with the inclusion of participants considered for add-on strategy, in the United States only, a cohort of approximately 50 participants who switch to a new single (monotherapy) pharmacological antidepressant agent of any antidepressant class per local prescribing information to replace the current antidepressant treatment (that is, "monotherapy switch strategy") will be enrolled. The enrollment of participants with switch to monotherapy will be monitored, and sites will be notified by the sponsor once the planned number for the cohort is achieved. Thereafter, only add-on strategy participants will be enrolled
Must be capable of providing informed consent (for example, able to read and write), based on the opinion of the participating physician. Must sign (or their legally acceptable representative) an informed consent form indicating that he or she understands the purpose of the study and that he or she agrees to have their data collected and analyzed, in accordance with local requirements and the study protocol
Meets the criterion for inadequate response to a current antidepressant treatment that includes an SSRI or SNRI (monotherapy SSRI, monotherapy SNRI, combination of antidepressants that includes SSRI/SNRI or SSRI/SNRI augmentation), administered at an adequate dose (as defined in the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression

Criterios de exclusión

Has a current or prior diagnosis of a psychotic disorder, MDD with psychotic features, bipolar or related disorders or intellectual disability, according to DSM-5 or ICD-10
Participants who require an antidepressant (SSRI/SNRI) change (switch to another antidepressant monotherapy), except for a limited number of participants to be recruited in the United States only
Unstable general medical condition (for example, cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic, or endocrine disorders) in the past 3 months that would compromise participation and normal routine medical care per the physician's clinical judgment
Has lack of treatment response to the current antidepressant therapy that includes a SSRI/SNRI (that is, no \[0%\] symptomatic improvement despite adequate dose and duration of the antidepressant treatment) assessed using the MGH ATRQ
History of dementia or mild cognitive impairment. Physician's clinical judgment should document that participant is capable of complying with observational study requirements and being able to complete the appropriate scales
Has homicidal ideation/intent or is at imminent risk of suicide per the physician's clinical judgment and/or based on the Columbia Suicide Severity Rating Scale (C-SSRS) corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent)

Ubicaciones

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Hospital Fleni

Ciudad Autonoma Buenos Aires, Argentina

CEN Consultorios Especializados en Neurociencias

Córdoba, Argentina

Instituto Medico DAMIC

Córdoba, Argentina

Centro Medico Luquez

Córdoba, Argentina

Resolution

Mendoza, Argentina

Estudio de las características de la enfermedad y la efectividad del estándar de atención en la vida real en pacientes con trastorno depresivo mayor (TDM) con anhedonia y respuesta inadecuada al tratamiento antidepresivo actual que incluye un ISRS o IRSN

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

No Intervention

Ubicaciones

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Hospital Italiano de Buenos Aires

Hospital Fleni

CEN Consultorios Especializados en Neurociencias

Instituto Medico DAMIC

Centro Medico Luquez

Resolution

Patrocinadores