Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder
Condition: Sleep Disturbances
MeSH terms: Dyssomnias; Parasomnias; Depressive Disorder; Depressive Disorder, Major
Intervention: Brexpiprazole
Intervention description: 2-3 mg/day, once daily, 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 judgment.
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep
      disturbances.
    

Eligibility criteria:

        Inclusion Criteria - at Screening:

          -  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 response on the Massachusetts
             General Hospital Antidepressant Treatment Response Questionnaire (ATRQ).

          -  The patient has a pre-defined Montgomery Aasberg Depression Rating Scale (MADRS) total
             score, and a pre-defined Clinical Global Impression - Severity of Illness (CGI-S)
             score at screening, and has had the current MDE for ≥10 weeks.

          -  The patient is currently treated for the current MDE with an adequate selective
             serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor
             (SNRI) antidepressant treatment for ≥6 weeks, at the same dosage for ≥2 weeks.

          -  The patient has sleep disturbances (difficulty falling asleep and/or difficulty
             staying asleep and/or problem waking up too early) confirmed by a pre-defined Insomnia
             Severity Index (ISI) score.

          -  The patient agrees to protocol-defined use of effective contraception.

        Entry Criteria to Treatment Period (Baseline Visit):

          -  The patient still fulfils DSM-IV-TR™ criteria for MDE.

          -  The patient received the same SSRI or SNRI antidepressant treatment at adequate dose
             during the entire lead-in period.

          -  The patient has a pre-defined MADRS total score.

          -  The patient's improvement in the MADRS total score is a pre-defined percentage
             compared to screening.

          -  The patient has a pre-defined Clinical Global Impression - Global Improvement (CGI-I)
             score.

          -  The patient has sleep disturbances (difficulty falling asleep and/or difficulty
             staying asleep and/or problem waking up too early) confirmed by a pre-defined ISI
             score.

          -  The patient has sleep disturbances confirmed by pre-defined Latency to Persistent
             Sleep (LPS) and pre-defined Sleep Efficiency (SE).

        Exclusion Criteria:

        - 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.