Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022)
Condition: Major Depressive Disorder, Recurrent
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Filorexant; Placebo
Intervention description: Filorexant, one 10 mg tablet, orally, once daily at bedtime; Placebo, one tablet, orally, once daily at bedtime
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Current depressive episode; moderate to severe

Summary:

      The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096)
      versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants
      who are partial responders to antidepressant monotherapy with one of identified selective
      serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors
      (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to
      placebo as augmentation therapy with respect to change from baseline to Week 6 in the
      Montgomery Asberg Depression Rating Scale (MADRS) total score.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is (a) male or (b) female and not of reproductive potential, or (c) female
             of reproductive potential has a serum beta-hCG level consistent with the nongravid
             state at screening and agrees to use acceptable contraception;

          -  Current primary diagnosis of recurrent major depressive disorder, without psychotic
             features, with a current moderate or severe depressive episode;

          -  Duration of the current major depressive episode must be at least 2 months but no more
             than 18 months at Screening;

          -  Participant has undergone an adequate trial of an antidepressant (one of identified
             SSRIs or SNRIs, or bupropion) for the current depressive episode.

        Key Exclusion Criteria:

          -  Current primary psychiatric diagnosis other than major depression;

          -  Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or
             other psychotic disorder;

          -  Alcohol or other substance abuse or dependence (excluding nicotine);

          -  Clinically significant abnormality or disease of the central nervous system (including
             dementia and other cognitive disorders or traumatic brain injury);

          -  Imminent risk of self-harm or of harm to others;

          -  Participant is a psychiatric inpatient;

          -  Participant has been on continuous antidepressant treatment for >18 months prior to
             Screening visit;

          -  Inadequate response to more than 3 adequate antidepressant trials (including the
             current antidepressant treatment trial) for treatment of the current depressive
             episode;

          -  Participant ever received electroconvulsive therapy, transcranial magnetic
             stimulation, or vagal nerve stimulation for treatment of depression;

          -  History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep-related
             breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive
             daytime sleepiness or difficulty sleeping due to a medical condition;

          -  Clinical, laboratory, or electrocardiogram (ECG) evidence of significant systemic
             disease;

          -  Cardiovascular event (e.g., myocardial infarction) or procedure (e.g., coronary artery
             bypass surgery) within 3 months of study;

          -  History of malignancy ≤5 years prior to study, except for adequately treated basal
             cell or squamous cell skin cancer or in situ cervical cancer;

          -  Body Mass Index >40 kg/m^2;

          -  Pregnancy, breast-feeding, or expecting to become pregnant.