Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Brexpiprazole 1 mg; Brexpiprazole 3 mg
Intervention description: Once daily, tablets, orally; once daily dose, tablets, orally; once daily dose, tablets, orally
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly
      patients with Major Depressive Disorder (MDD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is an outpatient consulting a psychiatrist.

          -  The patient has a recurrent Major Depressive Disorder diagnosed according to
             DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the
             Mini International Neuropsychiatric Interview (MINI).

          -  The patient had at least one previous MDE before the age of 60 years.

          -  The patient has a moderate to severe depression and an insufficient response to at
             least one and no more than three adequate antidepressants treatments.

          -  The patient, if a woman, must have had her last natural menstruation ≥24 months prior
             to the Screening Visit.

          -  The patient, if a man, agrees to protocol-defined use of effective contraception if
             his female partner is of childbearing potential.

        Exclusion Criteria:

          -  The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™
             criteria), established as the primary diagnosis, other than MDD.

          -  The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial,
             paranoid, schizoid, schizotypical or histrionic personality disorder.

          -  The patient has experienced/experiences hallucinations, delusions or any psychotic
             symptomatology in the current MDE.

          -  The patient suffers from mental retardation, organic mental disorders, or mental
             disorders due to a general medical condition (DSM-IV-TR™ criteria).

          -  The patient, in the opinion of the investigator, or according to Columbia Suicide
             Severity Rating Scale (C-SSRS), is at significant risk of suicide.

          -  The patient has had neuroleptic malignant syndrome.

          -  The patient has any relevant medical history or current presence of systemic disease.

          -  The patient has a neurodegenerative disorder.

          -  The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's
             opinion, clinically significant.

          -  The patient has a history of cancer, other than basal cell or Stage 1 squamous cell
             carcinoma of the skin, that has not been in remission for >5 years prior to the first
             dose of IMP.

          -  The patient is, in the investigator's opinion, unlikely to comply with the protocol or
             is unsuitable for any reason.

        Other inclusion and exclusion criteria may apply.