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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

495

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2008

Geographic Reach

5 countries

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

November 19, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed

10 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed

7.1 years until next milestone

Results Posted

Study results publicly available

March 20, 2018

Completed

Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

November 19, 2008

Results QC Date

February 17, 2018

Last Update Submit

March 16, 2018

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10
The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Baseline, Week 10

Secondary Outcomes (30)

Mean Change From Baseline (Week 10) in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 62
Baseline (Week 10), Week 62
Mean Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 10
Baseline, Week 10
Mean Change From Baseline (Week 10) in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 62
Baseline (Week 10), Week 62
Mean Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10
Baseline, Week 10
Mean Change From Baseline (Week 10) in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 62
Baseline (Week 10), Week 62
+25 more secondary outcomes

Study Arms (2)

LY2216684

EXPERIMENTAL

10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug. 1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of acute treatment phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).

Drug: LY2216684

Placebo

PLACEBO COMPARATOR

10-week Acute Treatment Phase: 3 tablets QD for 10 weeks 1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684 dose; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).

Drug: Placebo

Interventions

LY2216684DRUG

Flexible Dosing: 6 mg, 9 mg, 12 mg and 18 mg (3 tablets) administered QD for up to 62 weeks

LY2216684

PlaceboDRUG

Dose: 3 tablets QD for 10 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults age 18-65 years
Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders-fourth edition-text revision (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 17-item Hamilton Rating Scale for Depression (GRID-HAMD17) total score ≥18 at Visit 1 and Visit 2
Clinical global impressions of severity (CGI-S) score ≥4 at Visit 1 and Visit 2

You may not qualify if:

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 that would interfere with protocol compliance
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 judgment of the investigator, considered to have treatment-resistant depression
Participants 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 monoamine oxidase inhibitor (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
+7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (37)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Birmingham, Alabama, 35226, United States

Location

Little Rock, Arkansas, 72223, United States

Location

Beverly Hills, California, 90210, United States

Location

Cerritos, California, 90703, United States

Location

Denver, Colorado, 80239, United States

Location

Hamden, Connecticut, 06518, United States

Location

North Miami, Florida, 33161, United States

Location

Orlando, Florida, 32806, United States

Location

West Palm Beach, Florida, 33407, United States

Location

Atlanta, Georgia, 30328, United States

Location

Smyrna, Georgia, 30080, United States

Location

Overland Park, Kansas, 66212, United States

Location

Baltimore, Maryland, 21208, United States

Location

Willingboro, New Jersey, 08046, United States

Location

Albuquerque, New Mexico, 87109, United States

Location

Portland, Oregon, 97210, United States

Location

Memphis, Tennessee, 38119, United States

Location

San Antonio, Texas, 78229, United States

Location

Bellevue, Washington, 98007, United States

Location

Buenos Aires, C1425AHQ, Argentina

Location

La Plata, 1900, Argentina

Location

Helsinki, 00530, Finland

Location

Oulu, 90100, Finland

Location

Tampere, 33100, Finland

Location

Turku, 20100, Finland

Location

Bełchatów, 97-400, Poland

Location

Bialystok, 18-879, Poland

Location

Gdansk, 80 282, Poland

Location

Gorlice, 38-300, Poland

Location

Leszno, 64-100, Poland

Location

Lublin, 20-015, Poland

Location

Torun, 87-100, Poland

Location

Tuszyn, 95-080, Poland

Location

Kazan', 420012, Russia

Location

Rostov-on-Don, 344010, Russia

Location

Saint Petersburg, 191025, Russia

Location

Tomsk, 634014, Russia

Location

Related Publications (1)

Stauffer VL, Liu P, Goldberger C, Marangell LB, Nelson C, Gorwood P, Fava M. Is the Noradrenergic Symptom Cluster a Valid Construct in Adjunctive Treatment of Major Depressive Disorder? J Clin Psychiatry. 2017 Mar;78(3):317-323. doi: 10.4088/JCP.15m09972.
PMID: 27685842DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanol

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 21, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2010

Study Completion

March 1, 2011

Last Updated

March 20, 2018

Results First Posted

March 20, 2018

Record last verified: 2018-03

Locations

US(19)FI(4)PL(8)AR(2)RU(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (30)

Study Arms (2)

LY2216684

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (37)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations