A Study in Prevention of Re-emergence of Depression Symptoms
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: LY2216684; Placebo; SSRI
Intervention description: Participants should have been on their SSRI for at least 8 weeks prior and were to continue on their stable dose throughout the study.
Intervention MeSH terms: Serotonin; Selective Serotonin Reuptake Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1249.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to assess the maintenance of efficacy of LY2216684
      compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors
      (SSRIs) as measured by the time-to-symptom reemergence among participants with major
      depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the
      stabilization period.

      This trial consists of two distinct periods: an open-label treatment period, which consists
      of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if
      participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a
      randomized, double-blind, placebo-controlled period for 24 weeks.
    

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