NCT01185340

Brief Summary

The primary objective of this study is to assess whether LY2216684 12 milligrams (mg) or 18 mg flexible dose once daily is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who are partial responders to their selective serotonin reuptake inhibitor (SSRI) treatment.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,056

participants targeted

Target at P75+ for phase_3 major-depressive-disorder

Timeline
Completed

Started Mar 2011

Typical duration for phase_3 major-depressive-disorder

Geographic Reach
6 countries

48 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

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

April 27, 2018

Completed
Last Updated

April 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.1 years

First QC Date

August 18, 2010

Results QC Date

February 17, 2018

Last Update Submit

March 26, 2018

Conditions

Major Depressive Disorder

Keywords

DepressionMDD

Outcome Measures

Primary Outcomes (1)

  • Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 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 calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.

    Randomization, 8 weeks

Secondary Outcomes (18)

  • Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Score

    Randomization, 8 weeks

  • Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score

    Randomization, 8 weeks

  • Probability of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 at Week 8

    8 weeks

  • Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement

    Randomization up to 8 weeks

  • Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score

    Randomization, 8 weeks

  • +13 more secondary outcomes

Study Arms (2)

LY2216684 + SSRI

EXPERIMENTAL

LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Prior to entering the Adjunctive Treatment (AT) Phase, participants completed a 3-week Confirmation (CF) Phase where they received placebo (administered orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to the LY2216684 treatment arm. For the first 2 weeks of the AT Phase, participants received a starting dose of 12 mg QD. Then, based on efficacy and tolerability, the dose could be increased to 18 mg QD over the next 6 weeks. Participants who had their dose increased to 18 mg QD could have had their dose decreased to 12 mg QD. Participants who completed the AT Phase or discontinued early had the option to enter the Discontinuation (DC) Phase. During the 1-week abrupt DC Phase, participants maintained their SSRI treatment.

Drug: LY2216684Drug: PlaceboDrug: SSRI

Placebo + SSRI

PLACEBO COMPARATOR

Placebo: Administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Prior to entering the Adjunctive Treatment (AT) Phase, participants completed a 3-week Confirmation (CF) Phase where they received placebo (administered orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to the placebo treatment arm. During the AT Phase, participants received placebo (administered orally, QD) adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the Discontinuation (DC) Phase. During the 1-week abrupt DC Phase, participants maintained their SSRI treatment.

Drug: PlaceboDrug: SSRI

Interventions

LY2216684DRUG
Also known as: Edivoxetine
LY2216684 + SSRI
PlaceboDRUG
LY2216684 + SSRIPlacebo + SSRI
SSRIDRUG

Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study

Also known as: selective serotonin reuptake inhibitor
LY2216684 + SSRIPlacebo + SSRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control
  • Are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, or fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose
  • Drug and dosage should be within the labeling guidelines for the specific country
  • 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
  • Meet criteria for partial response, as defined by investigator's opinion that the participant has experienced a minimal clinically meaningful improvement with SSRI
  • Have a GRID 17-Item Hamilton Depression Rating Scale (GRID-HAMD17) total score greater than or equal to 16 at screening
  • Have less than or equal to 75% improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ)

You may not qualify if:

  • Have had or currently have any additional ongoing 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 \[OCD\], post-traumatic stress disorder \[PTSD\], generalized anxiety disorder \[GAD\], 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 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
  • Unstable medical conditions that contraindicate the use of LY2216684
  • Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, history of urinary hesitancy or retention
  • Use of excluded concomitant or psychotropic medication other than SSRI
  • Have initiated or discontinued hormone therapy within the 3 months 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (49)

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Garden Grove, California, 92845, United States

Location

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Oakland, California, 94612, United States

Location

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Temecula, California, 92591, United States

Location

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Waterbury, Connecticut, 06708, United States

Location

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Boca Raton, Florida, 33432, United States

Location

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Fort Myers, Florida, 33912, United States

Location

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North Bay Village, Florida, 33141, United States

Location

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Oakland Park, Florida, 33334, United States

Location

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Orlando, Florida, 32839, United States

Location

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West Palm Beach, Florida, 33407, United States

Location

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Shreveport, Louisiana, 71101, United States

Location

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Lincoln, Nebraska, 68526, United States

Location

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Marlton, New Jersey, 08053, United States

Location

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Brooklyn, New York, 11241, United States

Location

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New York, New York, 10003, United States

Location

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Staten Island, New York, 10312, United States

Location

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Cincinnati, Ohio, 45215, United States

Location

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Media, Pennsylvania, 19063, United States

Location

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Herndon, Virginia, 20170, United States

Location

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Richmond, Virginia, 23230, United States

Location

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Everton Park, Queensland, 4053, Australia

Location

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Spring Hill, Queensland, 4000, Australia

Location

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Frankston, Victoria, 3199, Australia

Location

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Heidelberg, Victoria, 3084, Australia

Location

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Malvern, Victoria, 3144, Australia

Location

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Melbourne, Victoria, 3004, Australia

Location

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Vienna, A1090, Austria

Location

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Diest, 3290, Belgium

Location

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Liège, 4000, Belgium

Location

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Mont-Godinne, 5530, Belgium

Location

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Bad Saarow, 15526, Germany

Location

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Berlin, 12209, Germany

Location

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Bochum, 44892, Germany

Location

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Cham, 93413, Germany

Location

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Dresden, 01097, Germany

Location

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Hattingen, 45525, Germany

Location

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Leipzig, 04107, Germany

Location

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Munich, 80331, Germany

Location

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Nuremberg, 90402, Germany

Location

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Prien am Chiemsee, 83209, Germany

Location

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Schwerin, 19053, Germany

Location

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Gothenburg, 41685, Sweden

Location

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Lund, 222 22, Sweden

Location

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Malmo, 21153, Sweden

Location

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Solna, 171 45, Sweden

Location

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Stockholm, 11486, Sweden

Location

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Bexhill-on-Sea, East Sussex, TN40 1JJ, United Kingdom

Location

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Glasgow, Scotland, G20 0XA, United Kingdom

Location

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Chesterfield, S40 4TF, United Kingdom

Location

Related Publications (2)

  • 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

  • Ball SG, Ferguson MB, Martinez JM, Pangallo BA, Nery ES, Dellva MA, Sparks J, Zhang Q, Liu P, Bangs M, Goldberger C. Efficacy outcomes from 3 clinical trials of edivoxetine as adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment. J Clin Psychiatry. 2016 May;77(5):635-42. doi: 10.4088/JCP.14m09619.

    PMID: 27035159DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanolSelective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 27, 2018

Results First Posted

April 27, 2018

Record last verified: 2018-03

Locations

BE(3)AU(6)GB(3)SE(5)DE(11)US(20)