A Study in Adult Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00795821
First received: November 19, 2008
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Depressive Disorder, Major
Drug: LY2216684
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • The Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 495
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Placebo Comparator: 2 Drug: Placebo
Dose: 3 tablets QD for 62 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795821

  Show 37 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00795821     History of Changes
Other Study ID Numbers: 11313, H9P-MC-LNBI
Study First Received: November 19, 2008
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014