Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy
Condition: Major Depressive Disorder; Irritability
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Brexpiprazole
Intervention description: 2-3 mg/day, once daily dose, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgement.
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.