Clinical trial NCT01185340 (phase 3, status: completed)
Conditions: major depressive disorder
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: ly2216684, placebo, ssri
SMILES: [H][C@]1(CNCCO1)[C@@](O)(CC1=C(OC)C=CC(F)=C1)C1CCOCC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CNCCC(OC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  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 being treated with one of the following selective serotonin reuptake inhibitors
             (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, or 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 Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR)
             criteria

          -  Meet criteria for partial response, as defined by investigator's opinion that the
             participant has experienced a minimal clinically meaningful improvement with SSRI

          -  Have a GRID 17-Item Hamilton Depression Rating Scale (GRID-HAMD17) total score greater
             than or equal to 16 at screening

          -  Have less than or equal to 75% improvement on the current SSRI at screening determined
             by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire
             (MGH-ATRQ)

        Exclusion Criteria:

          -  Have had or currently have any additional ongoing 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 [OCD], post-traumatic
             stress disorder [PTSD], generalized anxiety disorder [GAD], 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 year (drug
             categories defined by DSM-IV-TR), not including caffeine and nicotine

          -  Have an 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 that could be exacerbated by noradrenergic
             agents, including unstable hypertension, unstable heart disease, tachycardia,
             tachyarrhythmia, narrow-angled glaucoma, history of urinary hesitancy or retention

          -  Use of excluded concomitant or psychotropic medication other than SSRI

          -  Have initiated or discontinued hormone therapy within the 3 months 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 (VNS), transcranial magnetic
             stimulation (TMS), or psychosurgery

          -  Have received electroconvulsive therapy (ECT) in the past year