A Study in Adult Patients With Major Depressive Disorder

Tracking Information

Start Date  ICMJEDecember 2008
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
The 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00795821 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: November 19, 2008)
  • Sheehan Disability Scale (SDS) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions of Severity Scale (CGI-Severity) [ Time Frame: 63 weeks ] [ Designated as safety issue: No ]
  • The Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • The 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • The Euro-QoL Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • The Fatigue Associated With Depression (FAs-D) Patient Reported Outcome (PRO) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • The Brief Fatigue Inventory (BFI) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • The Visual Analogue Scale for Fatigue (VAS-F) [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • Resource Utilization Form [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
  • The Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 63 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study in Adult Patients With Major Depressive Disorder
Official Title  ICMJEA Randomized, Double-Blind Comparison of LY2216684 and Placebo and Long Term Treatment With LY2216684 in Adult Patients With Major Depressive Disorder
Brief Summary

The purpose of this study is to assess whether LY2216684 is superior to placebo in the treatment of adult patients with major depressive disorder.

Detailed Description 
Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEDepressive Disorder, Major
Intervention  ICMJE
  • Drug: LY2216684
    Flexible Dosing: 6 mg, 9 mg, 12 mg and 18 mg (3 tablets) administered QD for up to 62 weeks
    Other Name: LY2216684
  • Drug: Placebo
    Dose: 3 tablets QD for 62 weeks
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: LY2216684
  • 2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE376
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults age 18-65 years
  • Meet criteria for MDD as defined by DSM-IV-TR criteria without psychotic features
  • Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
  • Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score >=18 at visit 1 and visit 2
  • CGI-S score >=4 at visit 1 and visit 2

Exclusion Criteria:

  • Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug
  • Have previously completed or withdrawn from this study or any other study investigating LY2216684
  • Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD
  • Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of visit 1
  • Have an Axis II disorder which would interfere with compliance with the protocol
  • Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia or other psychotic disorder
  • Have a history of substance abuse within the past 1 year
  • Women who are pregnant or breast-feeding
  • Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy, or in the judgement of the investigator considered to have treatment resistant depression
  • Patients who are judged to be at serious suicidal risk
  • Have a serious or unstable medical illness
  • Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention
  • Have received treatment with a MAOI within 14 days prior to visit 1
  • Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
  • Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year
  • Have a history of any seizure disorder (other than febrile seizures)
  • Require psychotropic medication other than sedative/hypnotic medication for sleep
  • Have a thyroid stimulating hormone (TSH ) level outside the established reference range.
  • Are taking or have received treatment with any excluded medication within 7 days prior to visit 2
  • Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment
  • A positive urine drug screen for any substance of abuse at visit 1
  • Have initiate or discontinued hormone therapy within the previous 3 months prior to enrollment
Ages18 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
Location Countries  ICMJEUnited States,   Argentina,   Finland,   Poland,   Russian Federation

Administrative Information

Responsible PartyChief Medical Officer, Eli Lilly
Study ID Numbers  ICMJE11313, H9P-MC-LNBI
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Eli Lilly and Company
Information Provided ByEli Lilly and Company