A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: LY2216684; Placebo
Intervention description: Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.; 3 tablets PO QD for up to 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an
      adjunctive treatment for participants with major depressive disorder (MDD), who were
      identified as partial responders to an adequate course of treatment with a selective
      serotonin reuptake inhibitor (SSRI) (as defined by history).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR
             criteria)

          -  Meet criteria for partial response to an adequate course of treatment defined by the
             investigator's opinion that participant had attained at least minimal improvement on
             their current Selective serotonin reuptake inhibitor (SSRI) treatment

          -  Women of child-bearing potential must test negative for pregnancy and agree to use a
             reliable method of birth control

          -  Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or
             equal 16 to at both study entry and study enrollment

          -  SSRI treatment for at least 6 weeks at a stable dose for at least 2 weeks prior to
             study enrollment

          -  Stated participant preference for augmentation rather than switching antidepressant
             treatment

        Exclusion Criteria:

          -  Are currently involved in or discontinued within the last 30 days from a clinical
             trial involving an off-label use of an investigational drug

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY2216684

          -  Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other
             than MDD

          -  Have had any anxiety disorder preceding the onset of depression that was considered
             the primary diagnosis within 1 year of study entry

          -  Have a current or previous diagnosis of Bipolar I or II, psychotic depression,
             schizophrenia or other psychotic disorder

          -  Have a history of substance abuse within the past 1 year

          -  Have an Axis II disorder which, in the judgment of the investigator, would interfere
             with compliance with the protocol

          -  Have had a lack of response of the current depressive episode to 2 or more adequate
             courses of antidepressant therapy at a clinically appropriate dose for at least 4
             weeks, or in the judgment of the investigator, the participant has treatment-resistant
             depression

          -  Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation
             (TMS), or psychosurgery within the last year

          -  Women who are pregnant or breastfeeding

          -  Participants who are judged to be at serious risk for harm to self or others

          -  Have a serious or unstable medical illness

          -  Have any diagnosed medical condition which could be exacerbated by noradrenergic
             agents including unstable hypertension, unstable heart disease, tachycardia or
             tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention

          -  Have a history of severe allergies to more than 1 class of medication or multiple
             adverse drug reactions

          -  Have a history of any seizure disorder (other than febrile seizures)

          -  Are taking noradrenergic psychotropic medications, such as tricyclic antidepressants
             or serotonin norepinephrine reuptake inhibitors (SNRI)

          -  Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior
             to study entry

          -  Require psychotropic medication other than sedative/hypnotic medication for sleep

          -  Are taking or have received treatment with any excluded medication within 7 days prior
             to study enrollment

          -  Have a thyroid stimulating hormone (TSH ) level outside the established reference
             range

          -  Have initiate or discontinued hormone therapy within the previous 3 months prior to
             enrollment

          -  Initiation or change in intensity of psychotherapy or other non-drug therapies within
             6 weeks prior to enrollment

          -  A positive urine drug screen for any substance of abuse at study entry