A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment

Launched by ELI LILLY AND COMPANY · Aug 23, 2010

Keywords

ClinConnect Summary

Following the Confirmation (CF) Phase, participants were randomized to adjunctive LY2216684 or adjunctive placebo if they had \<25% improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over the past 3 weeks and a current MADRS total score ≥14. Participants who did not meet criteria received adjunctive placebo to preserve the blind.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• 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 an 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, and history of 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 (VNS) transcranial magnetic stimulation (TMS), or psychosurgery
• • Have received electroconvulsive therapy (ECT) in the past year
• • Enrollment in a clinical study for an investigational drug
• • Serious or unstable medical condition
• • 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