A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: LY2216684; Placebo; SSRI
Intervention description: Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study.
Intervention MeSH terms: Serotonin; Selective Serotonin Reuptake Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1416.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to assess whether at least 1 dose of LY2216684 (12
      milligrams [mg] or 18 mg once daily) is superior to placebo once daily in the adjunctive
      treatment of 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) during an 8-week, double-blind, acute adjunctive treatment phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Major Depressive Disorder (MDD)

          -  Women of child-bearing potential may participate but must test negative for pregnancy
             at the time of study entry; both women/men agree to use a reliable method of birth
             control

          -  Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment
             within the participant's country. The SSRI prescribed, including dose, should be
             consistent with labeling guidelines within the participating country.

          -  Have a partial response to SSRI treatment

          -  Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of
             depression, disease severity, and response to SSRI treatment

          -  Reliable and able to keep all scheduled appointments

        Exclusion Criteria:

          -  Presence of another primary psychiatric illness:

               -  Have had or currently have any additional ongoing Diagnostic and Statistical
                  Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1
                  condition other than major depression within 1 year of screening

               -  Have had any anxiety disorder that was considered a primary diagnosis within the
                  past year (including panic disorder, obsessive-compulsive disorder,
                  post-traumatic stress disorder, generalized anxiety disorder, and social phobia,
                  but excluding specific phobias)

               -  Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or
                  other psychotic disorder

               -  Have a history of substance abuse and/or dependence within the past 1 year (drug
                  categories defined by DSM-IV-TR), not including caffeine and nicotine

               -  Have a DSM-IV-TR Axis II disorder that, in the judgment of the investigator,
                  would interfere with compliance with protocol

          -  Have any diagnosed medical condition that could be exacerbated by noradrenergic agents
             including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia,
             narrow-angle glaucoma, urinary hesitation or retention

          -  Use of excluded concomitant or psychotropic medication other than SSRI

          -  Have initiated or discontinued hormone therapy within the previous 3 months of prior
             to enrollment

          -  History of treatment resistant depression as shown by 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 lifetime history of vagal nerve stimulation, transcranial magnetic stimulation,
             or psychosurgery

          -  Have received electroconvulsive therapy in the last year

          -  Enrollment in a clinical study for an investigational drug

          -  Serious or unstable medical condition

          -  History of seizure disorders

          -  Have initiated psychotherapy or other non-drug therapies (such as acupuncture or
             hypnosis) within 12 weeks prior to enrollment or any time during the study. Have no
             change in intensity of psychotherapy within the last 6 weeks prior to enrollment or at
             any time during the study.

          -  Participants who, in the opinion of the investigator, are judged to be at serious risk
             for harm to self or others