NCT01173601

Brief Summary

The primary purpose of this study is to assess whether at least 1 dose of LY2216684 (12 milligrams \[mg\] or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,416

participants targeted

Target at P75+ for phase_3 major-depressive-disorder

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_3 major-depressive-disorder

Geographic Reach
7 countries

63 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

July 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

July 29, 2010

Results QC Date

February 17, 2018

Last Update Submit

March 17, 2018

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

    The 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 (20)

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

    Randomization, 8 weeks

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

    Randomization, 8 weeks

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

    Randomization up to 8 weeks

  • Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 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

  • +15 more secondary outcomes

Study Arms (3)

12 milligrams (mg) LY2216684 + SSRI

EXPERIMENTAL

LY2216684: 12 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 12-mg treatment arm (AT Phase). Participants who completed the AT Phase or discontinued early entered a 2-week Discontinuation (DC) Phase. Participants were randomly assigned to either abrupt DC or tapered DC over the 2-week DC Phase. Participants maintained their SSRI treatment during the DC Phase.

Drug: LY2216684Drug: SSRI

18 milligrams (mg) LY2216684 + SSRI

EXPERIMENTAL

LY2216684: 12 milligrams (mg), administered orally, once daily (QD) for 1 week, followed by 18 mg, administered orally, once daily for 7 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 18-mg treatment arm (AT Phase). Participants who completed the AT Phase or discontinued early entered a 2-week Discontinuation (DC) Phase. Participants were randomly assigned to either abrupt DC or tapered DC over the 2-week DC Phase. Participants maintained their SSRI treatment during the DC Phase.

Drug: LY2216684Drug: SSRI

Placebo + SSRI

PLACEBO COMPARATOR

Placebo: Tablet equivalent to LY2216684, administered orally, once daily (QD) for 11 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 (AT Phase). Participants who completed the AT Phase or discontinued early had the option to enter the Discontinuation (DC) Phase. Participants who had received placebo were assigned to the abrupt DC over the 2-week DC Phase. Participants maintained their SSRI treatment during the DC Phase.

Drug: PlaceboDrug: SSRI

Interventions

LY2216684DRUG
Also known as: Edivoxetine
12 milligrams (mg) LY2216684 + SSRI18 milligrams (mg) LY2216684 + SSRI
PlaceboDRUG
Placebo + 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
12 milligrams (mg) LY2216684 + SSRI18 milligrams (mg) LY2216684 + SSRIPlacebo + SSRI

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of Major Depressive Disorder (MDD)
  • 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 taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participant's country. The SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country.
  • Have a partial response to SSRI treatment
  • Reliable and able to keep all scheduled appointments

You may not qualify if:

  • Presence of another primary psychiatric illness:
  • Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (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, post-traumatic stress disorder, generalized anxiety disorder, 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 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine
  • Have a DSM-IV-TR Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
  • Have any diagnosed medical condition that could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, urinary hesitation or retention
  • Use of excluded concomitant or psychotropic medication other than SSRI
  • Have initiated or discontinued hormone therapy within the previous 3 months of 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, transcranial magnetic stimulation, or psychosurgery
  • Have received electroconvulsive therapy in the last year
  • Enrollment in a clinical study for an investigational drug
  • Serious or unstable medical condition
  • History of seizure disorders
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (63)

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Irvine, California, 92618, United States

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La Habra, California, 90631, United States

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Redlands, California, 92374, United States

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Denver, Colorado, 80212, United States

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Jacksonville, Florida, 32256, United States

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Atlanta, Georgia, 30328, United States

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Marietta, Georgia, 30060, United States

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Baltimore, Maryland, 21208, United States

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St Louis, Missouri, 63109, United States

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Berlin, New Jersey, 08009, United States

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Jamaica, New York, 11432, United States

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New York, New York, 10023, United States

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Dayton, Ohio, 45417, United States

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Middleburg Heights, Ohio, 44130, United States

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Allentown, Pennsylvania, 18104, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75230, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77478, United States

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Murray, Utah, 84123, United States

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Milwaukee, Wisconsin, 53227, United States

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Fukuoka, 810-0001, Japan

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Fukushima, 960-0102, Japan

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Hyōgo, 660-0882, Japan

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Kanagawa, 238-0042, Japan

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Nagano, 390-0303, Japan

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Saga, 843-0023, Japan

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Tokyo, 170-0002, Japan

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Daugavpils, LV-5417, Latvia

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Jelgava, LV-3008, Latvia

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Liepāja, LV-3400, Latvia

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Sigulda, LV-2150, Latvia

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Strenči, LV-4730, Latvia

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?Uromin, 09-300, Poland

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Bialystok, 15-879, Poland

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Bydgoszcz, 85021, Poland

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Chełmno, 86-200, Poland

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Gdansk, 80-546, Poland

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Gorlice, 38/300, Poland

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Katowice, 40340, Poland

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Leszno, 64-100, Poland

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Lublin, 20-045, Poland

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Tuszyn, 95-080, Poland

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Moscow, 107076, Russia

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Rostov-on-Don, 344007, Russia

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Yekaterinburg, 620036, Russia

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Bellville, 7530, South Africa

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Cape Town, 7530, South Africa

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Centurion, 0157, South Africa

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George, 6529, South Africa

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West Cape, 7500, South Africa

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Chernihiv District, 14000, Ukraine

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Dnipropetrovsk, 49005, Ukraine

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Donetsk, 83037, Ukraine

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Kherson, 73488, Ukraine

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Kyiv, 01030, Ukraine

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Luhansk, 91045, Ukraine

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Odesa, 65006, Ukraine

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Poltava, 36013, Ukraine

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Simferopol, 95006, Ukraine

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Uzhhorod, 88000, Ukraine

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Vinnytsia, 21005, Ukraine

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, Major

Interventions

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

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

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
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

July 29, 2010

First Posted

August 2, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-03

Locations

JP(7)ZA(5)UA(11)RU(3)PL(10)LA(5)US(22)