We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

A Study in Adult Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00795821
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : April 14, 2011
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: LY2216684 Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Comparison of LY2216684 and Placebo and Long Term Treatment With LY2216684 in Adult Patients With Major Depressive Disorder
Study Start Date : December 2008
Primary Completion Date : February 2010
Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: 1 Drug: LY2216684
Flexible Dosing: 6 mg, 9 mg, 12 mg and 18 mg (3 tablets) administered QD for up to 62 weeks
Placebo Comparator: 2 Drug: Placebo
Dose: 3 tablets QD for 62 weeks

Primary Outcome Measures :
  1. The Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Sheehan Disability Scale (SDS) [ Time Frame: 62 weeks ]
  2. Clinical Global Impressions of Severity Scale (CGI-Severity) [ Time Frame: 63 weeks ]
  3. The Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 62 weeks ]
  4. The 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) [ Time Frame: 62 weeks ]
  5. The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: 62 weeks ]
  6. The Euro-QoL Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: 62 weeks ]
  7. The Fatigue Associated With Depression (FAs-D) Patient Reported Outcome (PRO) [ Time Frame: 62 weeks ]
  8. The Brief Fatigue Inventory (BFI) [ Time Frame: 62 weeks ]
  9. The Visual Analogue Scale for Fatigue (VAS-F) [ Time Frame: 62 weeks ]
  10. Resource Utilization Form [ Time Frame: 62 weeks ]
  11. The Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 63 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795821

  Show 37 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00795821     History of Changes
Other Study ID Numbers: 11313
H9P-MC-LNBI ( Other Identifier: Eli Lilly and Company )
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms