Clinical trial NCT01299272 (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:

          -  Outpatients with clinical diagnosis of Major Depressive Disorder (MDD)

          -  Using a reliable method of birth control

          -  Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment
             within the participant's country and 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

          -  Have had at least 1 previous episode of MDD prior to the current episode within the
             past 5 years

        Exclusion Criteria:

          -  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 a current or any 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 which could be exacerbated by noradrenergic
             agents, including unstable hypertension, unstable heart disease, tachycardia,
             tachyarrhythmia, narrow-angle glaucoma, or history of urinary hesitation or retention

          -  Have initiated or discontinued hormone therapy (including birth control or thyroid
             hormone) within the previous 3 months prior to enrollment

          -  Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic
             stimulation (TMS), or psychosurgery

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

          -  Have a serious or unstable medical condition

          -  Have a history of seizure disorders

          -  Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug
             therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or 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

          -  Are pregnant or breastfeeding

          -  Meet criteria for treatment-resistant depression