Clinical trial NCT01155661 (phase 3, status: completed)
Conditions: depressive disorder, major
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: ly2216684 (edivoxetine), ssri
SMILES: [H][C@]1(CNCCO1)[C@@](O)(CC1=C(OC)C=CC(F)=C1)C1CCOCC1, CNCCC(OC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1
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