A Safety Study in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: LY2216684 (edivoxetine); SSRI
Intervention description: 12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI); 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: Phenylethyl Alcohol; Serotonin; Selective Serotonin Reuptake Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 608.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the long-term safety and tolerability of
      LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin
      reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major
      depressive disorder (MDD) who are partial responders to their SSRI treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults competent and able to give informed consent

          -  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

          -  Participants who are being treated with one of the following selective serotonin
             reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine,
             paroxetine, and fluvoxamine; for at least 6 weeks prior to investigational product
             dispensing with at least the last 4 weeks at a stable, optimized dose

          -  Drug and dosage should be within the labeling guidelines for the specific country

          -  Meet criteria for Major Depressive Disorder (MDD), as defined by the Diagnostic and
             Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria

          -  Meet criteria for partial response, as defined by investigator's opinion that
             participant has experienced a minimal clinically meaningful improvement with SSRI

          -  Have a Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater
             than or equal to 16 at screening

          -  Have less than or equal to 75 percent improvement on the current SSRI at screening
             determined by the Massachusetts General Hospital Antidepressant Response Questionnaire
             (MGH-ATRQ)

          -  Meet all other inclusion criteria per protocol

        Exclusion Criteria:

          -  Presence of another primary psychiatric illnesses:

               -  Have had or currently have any additional ongoing DSM-IV-TR Axis I 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

          -  Unstable medical conditions that contraindicate the use of LY2216684

               -  Have any diagnosed medical condition which could be exacerbated by noradrenergic
                  agents including unstable hypertension, unstable heart disease, tachycardia,
                  tachyarrhythmia, narrow-angled 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:

               -  Have had 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, transcranial magnetic stimulation,
                  or psychosurgery within the last year

          -  Meet any other exclusion criteria per protocol