Clinical trial NCT01173601 (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:

          -  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