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A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment

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ClinicalTrials.gov Identifier: NCT01187407
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to assess if LY2216684 (flexible dose of 12 to 18 milligrams [mg] or fixed dose of 6 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Drug: LY2216684 Drug: Placebo Drug: SSRI Phase 3

Detailed Description:
Following the Confirmation (CF) Phase, participants were randomized to adjunctive LY2216684 or adjunctive placebo if they had <25% improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over the past 3 weeks and a current MADRS total score ≥14. Participants who did not meet criteria received adjunctive placebo to preserve the blind.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 mg to 18 mg Once Daily and LY2216684 Fixed-Dose 6 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
Study Start Date : March 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 12 or 18 mg flexible dose LY2216684 + SSRI

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 (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to a 12 or 18 mg flexible dose of LY2216684.

During the AT Phase, participants first received 6 mg LY2216684 QD for 3 days, followed by 12 mg QD for the next 11 days. Then, based on efficacy and tolerability, dosage could be increased to 18 mg QD over the next 6 weeks. Participants on 18 mg QD could have had their dose decreased back 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: LY2216684
Other Name: Edivoxetine
Drug: Placebo Drug: SSRI
Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study
Other Name: selective serotonin reuptake inhibitor
Experimental: 6 mg fixed dose LY2216684 + SSRI

LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI

Prior to entering the AT Phase, participants completed a 3-week CF Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to 6 mg fixed dose of LY2216684.

During the AT Phase, participants received a 6 mg fixed dose of LY2216684 adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase.

During the 1-week abrupt DC Phase, participants maintained their SSRI treatment.

Drug: LY2216684
Other Name: Edivoxetine
Drug: Placebo Drug: SSRI
Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study
Other Name: selective serotonin reuptake inhibitor
Placebo Comparator: Placebo + SSRI

Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI

Prior to entering the AT Phase, participants completed a 3-week CF Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to placebo.

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 DC Phase.

During the 1-week abrupt DC Phase, participants maintained their SSRI treatment.

Drug: Placebo Drug: SSRI
Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study
Other Name: selective serotonin reuptake inhibitor



Primary Outcome Measures :
  1. Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Randomization, 8 weeks ]
    The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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.


Secondary Outcome Measures :
  1. Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score [ Time Frame: Randomization, 8 weeks ]
    The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). 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.

  2. Change From Randomization to Week 8 in the Fatigue Associated With Depression (FAsD) Impact Subscale Score [ Time Frame: Randomization, 8 weeks ]
    The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. The FAsD impact subscale score ranges from 1 to 5. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.

  3. Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 up to Week 8 [ Time Frame: Randomization up to 8 weeks ]
    A MADRS total score of less than or equal to 10 was defined as remission criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission by the total number of participants analyzed, multiplied by 100%.

  4. 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 [ Time Frame: Randomization up to 8 weeks ]
    A MADRS total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement was defined as remission criteria at last 2 consecutive visits. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.

  5. Change From Randomization to Week 8 in the Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score [ Time Frame: Randomization, 8 weeks ]
    The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.

  6. Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8 [ Time Frame: Randomization up to 8 weeks ]
    A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the MADRS total score was defined as response criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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). Percentage of participants was calculated by dividing the number of participants meeting response criteria at last visit by the total number of participants analyzed, multiplied by 100%.

  7. Change From Randomization to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score [ Time Frame: Randomization, 8 weeks ]
    The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.

  8. Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items [ Time Frame: Randomization, 8 weeks ]
    The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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 item score, treatment-by-visit and baseline item score-by-visit.

  9. Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S) [ Time Frame: Randomization, 8 weeks ]
    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 (among the most extremely ill participants). 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

  10. Change From Randomization to Week 8 in The Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score [ Time Frame: Randomization, 8 weeks ]
    The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. 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.

  11. Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items [ Time Frame: Randomization, 8 weeks ]
    The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.

  12. Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) [ Time Frame: Randomization, 8 weeks ]
    The Q-LES-Q-SF is a self-administered 16 item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. 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.

  13. Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D) [ Time Frame: Randomization, 8 weeks ]
    The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. 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.

  14. Percentage of Participants With Treatment-emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Randomization through 8 weeks ]
    The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Event module.

  15. Change From Randomization to Week 8 in the Arizona Sexual Experiences (ASEX) Scale [ Time Frame: Randomization, 8 weeks ]
    The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) of the 5 items of the ASEX scale. Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction. 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.

  16. Change From Randomization to Week 8 in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: Randomization, 8 weeks ]
    The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Higher scores indicate greater disease severity. 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.

  17. Change From Randomization to Week 8 in Blood Pressure [ Time Frame: Randomization, 8 weeks ]
    Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.

  18. Change From Randomization to Week 8 in Pulse Rate [ Time Frame: Randomization, 8 weeks ]
    Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.

  19. Pharmacokinetics: Plasma Concentrations of LY2216684 [ Time Frame: Pre-randomization, 1 week, 4 weeks, and 8 weeks ]
    A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment
  • Reliable and able to keep all scheduled appointments

Exclusion Criteria:

  • 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 an 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, and history of 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 (VNS) transcranial magnetic stimulation (TMS), or psychosurgery
  • Have received electroconvulsive therapy (ECT) in the past year
  • Enrollment in a clinical study for an investigational drug
  • Serious or unstable medical condition
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187407


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United States, Alabama
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Birmingham, Alabama, United States, 35216
United States, Arizona
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Phoenix, Arizona, United States, 85032
United States, California
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Chino, California, United States, 91710
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Glendale, California, United States, 91204
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Imperial, California, United States, 92251
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National City, California, United States, 91950
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Sherman Oaks, California, United States, 91403
United States, Colorado
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Colorado Springs, Colorado, United States, 80907
United States, Florida
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Clearwater, Florida, United States, 33761
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Coral Gables, Florida, United States, 33145
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Fort Lauderdale, Florida, United States, 33319
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Tampa, Florida, United States, 33613
United States, Georgia
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Atlanta, Georgia, United States, 30308
United States, Illinois
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Hoffman Estates, Illinois, United States, 60169
United States, Indiana
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Indianapolis, Indiana, United States, 46260
United States, Kansas
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Prairie Village, Kansas, United States, 66206
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Wichita, Kansas, United States, 67205
United States, Maryland
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Baltimore, Maryland, United States, 21285
United States, Massachusetts
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Haverhill, Massachusetts, United States, 01830
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Weymouth, Massachusetts, United States, 02190
United States, Mississippi
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Flowood, Mississippi, United States, 39232
United States, Missouri
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O'Fallon, Missouri, United States, 63368
United States, New York
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Brooklyn, New York, United States, 11235
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New York, New York, United States, 10021
United States, Ohio
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Beachwood, Ohio, United States, 44122
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
United States, Texas
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Houston, Texas, United States, 77096
Croatia
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Rab, Croatia, 51280
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Zagreb, Croatia, 10090
Czechia
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Horovice, Czechia, 268 31
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Hostivice, Czechia, 25201
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Kladno, Czechia, 27201
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Olomouc, Czechia, 77900
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Prague, Czechia, 100 00
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Strakonice, Czechia, 38601
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Usti Nad Labem, Czechia, 400001
Finland
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Helsinki, Finland, 00100
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Joensuu, Finland, 80100
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Kuopio, Finland, 70110
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Tampere, Finland, 33200
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Turku, Finland, 20100
Japan
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Chiba, Japan, 270-0014
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Fukuoka, Japan, 810-0035
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Fukushima, Japan, 961-0021
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Hyogo, Japan, 661-0002
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Kanagawa, Japan, 247-0056
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Tokyo, Japan, 100-0006
Puerto Rico
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San Juan, Puerto Rico, 00918
Slovakia
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Bratislava, Slovakia, 85101
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Kosice, Slovakia, 04001
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Michalovce, Slovakia, SK-071 01
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Rimavska Sobota, Slovakia, 97901
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Roznava, Slovakia, 04801
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01187407     History of Changes
Other Study ID Numbers: 12182
H9P-MC-LNBQ ( Other Identifier: Eli Lilly and Company )
First Posted: August 24, 2010    Key Record Dates
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin
Serotonin Uptake Inhibitors
Phenylethyl Alcohol
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants