A Study of LY2216684 in Participants With Major Depression Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: LY2216684; SSRI
Intervention description: Participants were to enter the study taking their current stable SSRI treatment dose and maintain the same dose throughout the study.
Intervention MeSH terms: Serotonin; Selective Serotonin Reuptake Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the long-term safety and tolerability of
      LY2216684 administered once daily in the adjunctive treatment with an Selective Serotonin
      Reuptake Inhibitors (SSRI) for up to approximately 1 year in participants with Major
      Depressive Disorder (MDD) who were partial responders to their SSRI treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have completed Study LNBM: NCT01173601 or Study LNBQ: NCT01187407

          -  Participants must be competent and able to give their own informed consent

        Exclusion Criteria:

          -  Participants that have had or currently have any additional ongoing Diagnostic and
             Statistical Manual of Mental Disorder, fourth edition, text revision (DSM-IV-TR) Axis
             I condition other than major depression that was considered the primary diagnosis
             within 1 year of entering trial

          -  Participants that have had any anxiety disorder that was considered a primary
             diagnosis within the past year

          -  Participants that have a current or previous diagnosis of bipolar disorder,
             schizophrenia, or other psychotic disorder

          -  Participants that have a history of substance abuse within the past 1 year, and/or
             substance dependence within the past 1 year, not including caffeine and nicotine

          -  Participants that have an Axis II disorder that, in the judgment of the investigator,
             would interfere with compliance with the study

          -  Participants that have had a lack of full 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

          -  Participants that have a history of electroconvulsive therapy (ECT), transcranial
             magnetic stimulation (TMS), or psychosurgery within the last year

          -  Participants who are women who are pregnant or breastfeeding

          -  Participants who, in the opinion of the investigator, are judged to be at serious risk
             for harm to self or others

          -  Participants that have a serious or unstable medical illness

          -  Participants that have any diagnosed medical condition which could be exacerbated by
             noradrenergic agents

          -  Participants that have a history of severe allergies to more than 1 class of
             medication or multiple adverse drug reactions

          -  Participants that have a history of any seizure disorder (other than febrile seizures)

          -  Participants that have received treatment with a monoamine oxidase inhibitor (MAOI)
             within 14 days prior to entering trial or have a potential need to use an MAOI within
             3 days after discontinuation from the study

          -  Participants that require psychotropic medication other than sedative/hypnotic
             medication for sleep

          -  Participants who are taking or have received treatment with any excluded medications
             within 7 days prior to entering trial

          -  Participants that have a thyroid stimulating hormone (TSH) level outside the
             laboratory established reference range. Participants previously diagnosed with
             hyperthyroidism or hypothyroidism who have been treated with a stable dose of thyroid
             supplement for at least the past 3 months, and who are clinically and chemically
             euthyroid will be allowed to participate in the study.

          -  Participants that have initiated or discontinued hormone therapy within the previous 3
             months prior to enrollment

          -  Participants that have initiated psychotherapy, change in intensity of psychotherapy
             or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to
             enrollment or at any time during the study.

          -  Participants have a positive urine drug screen (UDS) for any substances of abuse on
             entering trial

          -  Participants have significantly violated rules that a participant must comply with
             during Study LNBM: NCT01173601 or Study LNBQ: NCT01187407