study of brexpiprazole as adjunctive treatment of irritability in patients with major depressive disorder and an inadequate response to antidepressant therapy

Conditions: Major Depressive Disorder; Irritability

Summary: to explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability.


Eligibility criteria:
inclusion criteria: main selection criteria at screening visit: * the patient has a major depressive episode (mde) associated to major depressive disorder (mdd) diagnosed according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr™). the current mde should be confirmed using the mini international neuropsychiatric interview (mini) * the patient has an inadequate response to at least one antidepressant treatment (including the treatment the patient is taking at screening) in the current mde, as documented by self-report as less than a pre-defined percentage response on the massachusetts general hospital antidepressant treatment response questionnaire (atrq). * pre-defined madrs total score * pre-defined cgi-s total score * the patient has had the current mde for ≥10 weeks * the patient is receiving a ssri or snri antidepressant treatment for ≥6 weeks, at same dosage for ≥2 weeks * pre-defined inventory of depressive symptomatology - clinician-rated - 30 items (ids-c 30) item 6 mood (irritable) score main inclusion criteria at baseline visit: * the patient still fulfils dsm-iv-tr™ criteria for mde * pre-defined madrs total score * pre-defined cgi-i (lead-in period) score * the patient received the same ssri or snri antidepressant treatment at adequate doses during the entire lead-in period * the patient has less than a pre-defined percentage decrease in madrs score at the end of the lead-in period as compared to the screening visit * the patient still has the pre-defined ids-c 30 item 6 mood (irritable) score exclusion criteria: * the patient has any current psychiatric disorder or axis i disorder (dsm-iv-tr™ criteria), established as the principal diagnosis, other than mdd. all anxiety disorders, impulse-control disorders such as intermittent explosive disorder, as well as non-suicidal self-injury are not excluded diagnoses as far as they are not considered as principal diagnosis. * the patient has a current axis ii (dsm-iv-tr™) diagnosis of antisocial, borderline, paranoid, schizoid, schizotypical, or histrionic personality disorder. * the patient has experienced/experiences hallucinations, delusions, or any psychotic symptomatology in the current mde. * the patient, in the opinion of the investigator or based on c-ssrs rating, is at significant risk of suicide. * the patient has started formal cognitive or behavioural therapy or systematic psychotherapy within 6 weeks prior to screening, or plans to start such therapy during the study. any ongoing formal psychotherapy initiated more than 6 weeks prior to screening should be continued with the same methodology and at the same frequency and intensity during the entire study. * the patient has a current diagnosis or history of substance abuse or dependence (excluding nicotine or caffeine) or alcohol abuse or dependence (dsm-iv-tr™ criteria) \<6 months prior to the screening visit. * the patient reports adjunctive treatment with an antipsychotic medication together with an antidepressant for 3 weeks or more during the current mde. * the patient has received electroconvulsive therapy (ect) \<6 months prior to the screening visit or at any time during the current mde (if its duration is longer than 6 months). * the patient has had vagus nerve stimulation or a deep brain stimulation device implanted for the management of depression. other inclusion and exclusion criteria may apply.