Treatment-resistant Depression
Conditions
Interventions
The study will include about 750 participants worldwide, with 90 coming from 19 Brazilian site centers (about 5 participants per center). Esketamine group: Open-Label Induction Phase: Participants wil
Drug
Sponsors
Centro De Psiquiatria E Pesquisas Sandra Ruschel Ltda
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Research participants with direct Entry: The study population will include men and women with 18 years of age who meet the Manual of diagnostic criteria Diagnostic and Statistical of Mental Disorders (5th edition, DSM-5) for recurrent MDD or MDD single episode ( a single episode, the episode duration should be 2 years) without psychotic features, based on clinical evaluation and confirmed by Mini International Neuropsychiatric Interview (MINI). In screening, the research participant must have a MADRS total score 22, which corresponds to at least moderate depression .Research participants with direct entry will be eligible for screening regardless of whether they are taking or not currently oral antidepressant medications. In screening, the research participants with direct entry must habe no response to two different oral antidepressant treatments administered in proper dosage and proper duration (including oral antidepressant currently taken, if applicable), as measured in MGH-ATRQ and documented by history medical and / or pharmacy records / prescription for the current episode .Research participants with transfer entry. All survey participants with transfer entry (elderly research participants with 65 years of age) who completed the double-phase induction blind ESKETINTRD3005 study will be eligible for this study: nonresponders research participants will join the study at the beginning of the open induction phase; responders research participants will join the study from the beginning of the optimization/maintenance phase.
Exclusion criteria
Exclusion criteria: Potential research participants will be excluded from participation in the study if they have previously shown no response of depressive symptoms to escetamina or ketamine in the current major depressive episode or all of the oral antidepressant treatment available in their country in the open induction phase (ie, duloxetine, escitalopram, sertraline and venlafaxine XR) in the current major depressive episode (based on MGH-ATRQ). Research participants will also be excluded if they have a DSM-5 diagnostic current or previous a psychotic or MDD disorder with psychosis, bipolar and related disorders (confirmed by MINI), obsessive compulsive disorder comorbid, intellectual disability (DSM-5 diagnostic codes 317 , 318.0, 318.1, 318.2, 315.8 and 319), autistic spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder or narcissistic personality disorder; if they presented ideation / homicidal or suicidal ideation intent with any intention to act within 6 months before the screening phase according to the clinical judgment of the investigator and / or based on Suicide Severity Rating Scale Columbia ( CSSRS); or have a history of disorder or substance use moderate or severe alcohol according to the DSM-5. Furthermore, study participants with 65 ages will be excluded if they have neurodegenerative disorders (eg., Alzheimer's disease, vascular dementia, Parkinson's disease) or mild cognitive impairment evidence (MCI) or a score of the Mini Mental State Examination ( MMSE) 25.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) score greater than (>)18 over time;Day 1 up to end of follow up phase; Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS), is a scale to monitor for symptoms of cystitis, bladder pain, and interstitial cystitis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Baseline of Generalized Anxiety Disorder score reported participant (GAD-7); The GAD-7 is a brief and validated measure of general anxiety; Baseline change in operation and participant-reported disability assessed by the total score on the Sheehan Disability Scale (SDS). SDS is a measure effects reported by the participants and it is a questionnaire of 5 items that have been widely used and accepted for functional impairment assessment and associated disability; Baseline change in score of the Clinical Global Impression - Severity (CGI-S); The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering the overall clinical experience, the participant is evaluated the severity of the mental illness. The CGI-S allows an overall assessment of the participant's condition at any given time; Baseline change in participant-reported depressive symptoms by the total score in the patient health questionnaire 9 (PHQ-9). The PHQ-9 is a 9-item scale used to evaluate depressive symptoms. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, France, Germany, Italy, Malaysia, Mexico, Poland, Romania, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed