NCT01299272

Brief Summary

The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period. This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,249

participants targeted

Target at P75+ for phase_3 major-depressive-disorder

Timeline
Completed

Started May 2011

Typical duration for phase_3 major-depressive-disorder

Geographic Reach
16 countries

77 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

February 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 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

2.5 years

First QC Date

February 16, 2011

Results QC Date

February 17, 2018

Last Update Submit

March 16, 2018

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Meet Criteria for Re-emergence of Depressive Symptoms Estimated by Kaplan-Meier Product Limit Method (Double-blind Randomized Withdrawal Period)

    Participants meeting any of the following criteria were determined as having major depressive disorder symptom re-emergence: 1) a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater ≥14 or a Clinical Global Impressions of Severity (CGI-S) increase of 2 or more points from Week 18 at 2 consecutive visits or 2) discontinuation due to lack of efficacy/worsening of depression/suicidality. Time from randomization to the first visit at which the participant met the reemergence criteria was calculated. The percentage of participants who meet criteria was estimated using the Kaplan-Meier product limit method. The MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity) to 60 (high severity). CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).

    Randomization up to 44 weeks

Secondary Outcomes (28)

  • Percentage of Participants With Re-emergence of Depressive Symptoms (Double-blind Randomized Withdrawal Period)

    Week 44

  • Change From Randomization in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores at Week 44 (Double-blind Randomized Withdrawal Period)

    Randomization, Week 44

  • Change From Randomization in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores at Week 44 (Double-blind Randomized Withdrawal Period)

    Randomization, Week 44

  • Change From Randomization in the Clinical Global Impression of Severity (CGI-S) Scores at Week 44 (Double-blind Randomized Withdrawal Period)

    Randomization, Week 44

  • Change From Randomization in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score at Week 44 (Double-blind Randomized Withdrawal Period)

    Randomization, Week 44

  • +23 more secondary outcomes

Study Arms (2)

LY2216684 + SSRI

EXPERIMENTAL

Acute Open-label (OL) Period: Participants received a starting dose of 12 milligrams (mg) LY2216684, administered orally, once daily for at least 2 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). Then, based on efficacy and tolerability, the dose could be increased to 18 mg (and decreased back to 12 mg) over the next 6 weeks. Stabilization OL Period: Participants meeting remission criteria continued on the same dose of LY2216684 for an additional 12 weeks. Participants who discontinued early during either OL Period were discontinued abruptly from LY2216684. Double-blind (DB) Randomized Withdrawal Period: At 20 weeks, participants meeting criteria for randomization continued their current dose of LY2216684 for another 24 weeks. Participants who completed this period or discontinued early were randomized to abrupt (placebo for 2 weeks) or tapered (12 mg LY2216684 for 4 days, 6 mg LY2216684 for 4 days, then placebo for 6 days) discontinuation of LY2216684.

Drug: LY2216684Drug: SSRI

Placebo + SSRI

PLACEBO COMPARATOR

Acute Open-label (OL) Period: Participants received a starting dose of 12 milligrams (mg) LY2216684, administered orally, once daily for at least 2 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI). Then, based on efficacy and tolerability, the dose could be increased to 18 mg (and decreased back to 12 mg) over the next 6 weeks. Stabilization OL Period: Participants meeting remission criteria continued on the same dose of LY2216684 for an additional 12 weeks. Participants who discontinued early during either OL Period were discontinued abruptly from LY2216684. Double-blind (DB) Randomized Withdrawal Period: At 20 weeks, participants meeting criteria for randomization were tapered from their LY2216684 dose to placebo following the regimen of 12 mg for 7 days, 6 mg for 7 days, and placebo for the remaining 22 weeks. Participants who completed this period or discontinued early continued to receive placebo for an additional 2 weeks

Drug: LY2216684Drug: PlaceboDrug: SSRI

Interventions

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

Participants should have been on their SSRI for at least 8 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:

  • Outpatients with clinical diagnosis of Major Depressive Disorder (MDD)
  • Using a reliable method of birth control
  • Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participant's country and 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
  • Have had at least 1 previous episode of MDD prior to the current episode within the past 5 years

You may not qualify if:

  • 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 a current or any 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 which could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, or history of urinary hesitation or retention
  • Have initiated or discontinued hormone therapy (including birth control or thyroid hormone) within the previous 3 months prior to enrollment
  • Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery
  • Have received electroconvulsive therapy (ECT) in the past year
  • Have a serious or unstable medical condition
  • Have a history of seizure disorders
  • Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study
  • Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others
  • Are pregnant or breastfeeding
  • Meet criteria for treatment-resistant depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (77)

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Redlands, California, 92374, United States

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Sherman Oaks, California, 91403, United States

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Wildomar, California, 92595, United States

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Coral Gables, Florida, 33145, United States

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Gainesville, Florida, 32607, United States

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Atlanta, Georgia, 30338, United States

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Libertyville, Illinois, 60048, United States

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Lafayette, Indiana, 47905, United States

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Terre Haute, Indiana, 47802, United States

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Prairie Village, Kansas, 66206, United States

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Boston, Massachusetts, 02131, United States

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Las Vegas, Nevada, 89104, United States

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Cherry Hill, New Jersey, 08002, United States

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Albuquerque, New Mexico, 87109, United States

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Brooklyn, New York, 11214, United States

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New York, New York, 10021, United States

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Rochester, New York, 14618, United States

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Staten Island, New York, 10312, United States

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Charlotte, North Carolina, 28211, United States

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Greensboro, North Carolina, 27408, United States

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Cincinnati, Ohio, 45219, United States

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Oklahoma City, Oklahoma, 73109, United States

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Philadelphia, Pennsylvania, 19139, United States

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Austin, Texas, 78756, United States

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Clinton, Utah, 84015, United States

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Spokane, Washington, 99204, United States

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Middleton, Wisconsin, 53562, United States

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Buenos Aires, C1058AAJ, Argentina

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Córdoba, X5009BIN, Argentina

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La Plata, 1900, Argentina

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Heusden-Zolder, 3550, Belgium

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Split, 21000, Croatia

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Zagreb, 10000, Croatia

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Arcachon, 33120, France

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Caen, 14000, France

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Dole, 39100, France

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Douai, 59500, France

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Élancourt, 78990, France

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Fains, 55000, France

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Toulon, 83000, France

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Toulouse, 31000, France

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Dresden, 01307, Germany

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Hamburg, 22143, Germany

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Hanover, 30159, Germany

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Oranienburg, 16515, Germany

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Haidari, 12462, Greece

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Thessaloniki, 56429, Greece

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Tripoli, 22100, Greece

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Camaiore-Viareggio, 55043, Italy

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Catania, 95125, Italy

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Colleferro, 00034, Italy

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Ferrara, 44100, Italy

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Siena, 53100, Italy

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Fracc. Bosques Del Prado Norte, 20217, Mexico

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Guadalajara, 45170, Mexico

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Ponce, 00731-7779, Puerto Rico

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San Juan, 00927, Puerto Rico

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Bucharest, 041914, Romania

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Focşani, 620165, Romania

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Târgu Mureş, 540139, Romania

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Moscow, 115522, Russia

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Saint Petersburg, 190121, Russia

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Smolensk, 214019, Russia

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Stavropol, 355038, Russia

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Tomsk, 634014, Russia

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Banská Bystrica, 97409, Slovakia

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Bratislava, 81107, Slovakia

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Svidník, 08901, Slovakia

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Zvolen, 96001, Slovakia

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Gwangju, 501-757, South Korea

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Seoul, 137-040, South Korea

Location

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.

Madrid, 28029, Spain

Location

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Palma de Mallorca, 07013, Spain

Location

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Salamanca, 37003, Spain

Location

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Seville, 41700, Spain

Location

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Adapazarı, 200130, Turkey (Türkiye)

Location

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.

Diyarbakır, 21280, Turkey (Türkiye)

Location

Related Publications (1)

  • Oakes TM, Dellva MA, Waterman K, Greenbaum M, Poppe C, Goldberger C, Ahl J, Perahia DG. Edivoxetine compared to placebo as adjunctive therapy to selective serotonin reuptake inhibitors in the prevention of symptom re-emergence in major depressive disorder. Curr Med Res Opin. 2015 Jun;31(6):1179-89. doi: 10.1185/03007995.2015.1037732. Epub 2015 May 6.

    PMID: 25894953DERIVED

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 18, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-03

Locations

AR(3)PR(2)RO(3)CR(2)RU(5)GR(3)US(27)DE(4)KR(2)TU(2)IT(5)FR(8)BE(1)ES(4)ME(2)SL(4)