A Study in Prevention of Re-emergence of Depression Symptoms

Last updated: March 16, 2018
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Depression (Adult And Geriatric)

Affective Disorders

Depression

Treatment

N/A

Clinical Study ID

NCT01299272
11317
H9P-MC-LNBN
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 treatmentwithin the participant's country and the SSRI prescribed, including dose, should beconsistent with labeling guidelines within the participating country

  • Have a partial response to SSRI treatment

  • Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis ofdepression, disease severity, and 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 thepast 5 years

Exclusion

Exclusion Criteria:

  • Have had or currently have any additional ongoing Diagnostic and Statistical Manual ofMental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition otherthan major depression within 1 year of screening

  • Have a current or any previous diagnosis of a bipolar disorder, schizophrenia, orother psychotic disorder

  • Have a history of substance abuse and/or dependence within the past 1 year (drugcategories 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, wouldinterfere with compliance with protocol

  • Have any diagnosed medical condition which could be exacerbated by noradrenergicagents, 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 thyroidhormone) within the previous 3 months prior to enrollment

  • Have a lifetime history of vagal nerve stimulation (VNS), transcranial magneticstimulation (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 nondrugtherapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or anytime during the study

  • Participants who, in the opinion of the investigator, are judged to be at serious riskfor harm to self or others

  • Are pregnant or breastfeeding

  • Meet criteria for treatment-resistant depression

Study Design

Total Participants: 1249
Study Start date:
May 01, 2011
Estimated Completion Date:
November 30, 2013

Study Description

In order to enter the Stabilization Open-label Period, participants must have met remission criteria, defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤10 at Week 8. In order to enter the Double-blind Randomization Withdrawal Period, participants must have met randomization criteria, defined as a MADRS total score ≤10 at Weeks 18, 19, and 20.

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    United States

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  • 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.

    Brooklyn, New York 11214
    United States

    Site Not Available

  • 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.

    New York, New York 10021
    United States

    Site Not Available

  • 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.

    Rochester, New York 14618
    United States

    Site Not Available

  • 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.

    Staten Island, New York 10312
    United States

    Site Not Available

  • 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.

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • 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.

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • 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.

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • 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.

    Oklahoma City, Oklahoma 73109
    United States

    Site Not Available

  • 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.

    Philadelphia, Pennsylvania 19139
    United States

    Site Not Available

  • 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.

    Austin, Texas 78756
    United States

    Site Not Available

  • 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.

    Clinton, Utah 84015
    United States

    Site Not Available

  • 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.

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • 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.

    Spokane, Washington 99204
    United States

    Site Not Available

  • 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.

    Middleton, Wisconsin 53562
    United States

    Site Not Available

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