NCT01155661

Brief Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
608

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2010

Geographic Reach
7 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

June 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5.4 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

2.2 years

First QC Date

June 30, 2010

Results QC Date

February 17, 2018

Last Update Submit

March 16, 2018

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

  • The Number of Participants Experiencing Clinically Significant Effects

    A clinically significant effect was defined as a serious adverse event, regardless of causality. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.

    Baseline through 54 weeks

Secondary Outcomes (21)

  • Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Baseline through Week 54

  • Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale

    Baseline, Week 54

  • Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)

    Baseline, Week 54

  • Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items

    Baseline, Week 54

  • Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score

    Baseline, Week 54

  • +16 more secondary outcomes

Study Arms (1)

LY2216684 (edivoxetine) + SSRI

EXPERIMENTAL
Drug: LY2216684 (edivoxetine)Drug: SSRI

Interventions

LY2216684 (edivoxetine)DRUG

12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Also known as: LY2216684, edivoxetine
LY2216684 (edivoxetine) + 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 (edivoxetine) + SSRI

Eligibility Criteria

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

You may qualify if:

  • Adults competent and able to give informed consent
  • 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
  • Participants who are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and 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 the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria
  • Meet criteria for partial response, as defined by investigator's opinion that participant has experienced a minimal clinically meaningful improvement with SSRI
  • Have a Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal to 16 at screening
  • Have less than or equal to 75 percent improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH-ATRQ)

You may not qualify if:

  • Presence of another primary psychiatric illnesses:
  • Have had or currently have any additional ongoing DSM-IV-TR Axis I 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
  • Unstable medical conditions that contraindicate the use of LY2216684
  • Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled 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:
  • Have had 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 history of electroconvulsive therapy, transcranial magnetic stimulation, or psychosurgery within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

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, 35216, United States

Location

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Little Rock, Arkansas, 72223, United States

Location

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Cerritos, California, 90703, United States

Location

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Irvine, California, 92618, United States

Location

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Los Alamitos, California, 90720, United States

Location

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Redlands, California, 92374, United States

Location

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Riverside, California, 92506, United States

Location

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San Diego, California, 92121, United States

Location

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Upland, California, 91786, United States

Location

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Fort Walton Beach, Florida, 32547, United States

Location

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Gainesville, Florida, 32607, United States

Location

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Orlando, Florida, 32806, United States

Location

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Indianapolis, Indiana, 46260, United States

Location

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Prairie Village, Kansas, 66206, United States

Location

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Boston, Massachusetts, 02135, United States

Location

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Princeton, New Jersey, 08540, United States

Location

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Albuquerque, New Mexico, 87109, United States

Location

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Mount Kisco, New York, 10549, United States

Location

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New York, New York, 10021, United States

Location

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Rochester, New York, 14618, United States

Location

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The Bronx, New York, 10467, United States

Location

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Philadelphia, Pennsylvania, 19139, United States

Location

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Dallas, Texas, 75231, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Aparecida de Goiânia, 74922-810, Brazil

Location

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Belo Horizonte, 30210420, Brazil

Location

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Botucatu, 18618 970, Brazil

Location

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Pelotas, 96030-000, Brazil

Location

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Ribeirão Preto, 14051-140, Brazil

Location

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Rio de Janeiro, 22270060, Brazil

Location

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Salvador, 40301500, Brazil

Location

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São Paulo, 05403-010, Brazil

Location

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Antofagasta, 1270244, Chile

Location

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Santiago, 7500710, Chile

Location

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Kaunas, LT-3005, Lithuania

Location

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Klaipėda, 91251, Lithuania

Location

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León, 37000, Mexico

Location

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Mazatlán, 82000, Mexico

Location

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Mexico City, 01030, Mexico

Location

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Monterrey, 64040, Mexico

Location

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San Luis Potosí City, 78250, Mexico

Location

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Villahermosa, 86035, Mexico

Location

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Zapopan, 45200, Mexico

Location

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Heerde, 8181 CX, Netherlands

Location

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Wildervank, 9648 BE, Netherlands

Location

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Alcalá de Henares, 28806, Spain

Location

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Madrid, 28029, Spain

Location

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Zamora, 49021, Spain

Location

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 2, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-03

Locations

LI(2)US(24)BR(8)CL(2)ME(7)NL(2)ES(3)