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
25 maart 2018 bijgewerkt door: Eli Lilly and Company
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
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1480
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Helsinki, Finland, 00100
- 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.
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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
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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
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Rab, Kroatië, 51280
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Zagreb, Kroatië, 10090
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San Juan, Puerto Rico, 00918
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Bratislava, Slowakije, 85101
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Kosice, Slowakije, 04001
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Michalovce, Slowakije, SK-071 01
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Rimavska Sobota, Slowakije, 97901
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Roznava, Slowakije, 04801
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Horovice, Tsjechië, 268 31
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Hostivice, Tsjechië, 25201
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Kladno, Tsjechië, 27201
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Olomouc, Tsjechië, 77900
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Prague, Tsjechië, 100 00
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Strakonice, Tsjechië, 38601
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Usti Nad Labem, Tsjechië, 400001
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35216
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85032
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California
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Chino, California, Verenigde Staten, 91710
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Glendale, California, Verenigde Staten, 91204
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Imperial, California, Verenigde Staten, 92251
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National City, California, Verenigde Staten, 91950
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Sherman Oaks, California, Verenigde Staten, 91403
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80907
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Florida
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Clearwater, Florida, Verenigde Staten, 33761
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Coral Gables, Florida, Verenigde Staten, 33145
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Fort Lauderdale, Florida, Verenigde Staten, 33319
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Tampa, Florida, Verenigde Staten, 33613
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30308
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Illinois
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Hoffman Estates, Illinois, Verenigde Staten, 60169
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46260
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Kansas
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Prairie Village, Kansas, Verenigde Staten, 66206
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Wichita, Kansas, Verenigde Staten, 67205
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21285
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Massachusetts
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Haverhill, Massachusetts, Verenigde Staten, 01830
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Weymouth, Massachusetts, Verenigde Staten, 02190
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Mississippi
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Flowood, Mississippi, Verenigde Staten, 39232
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Missouri
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O'Fallon, Missouri, Verenigde Staten, 63368
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New York
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Brooklyn, New York, Verenigde Staten, 11235
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New York, New York, Verenigde Staten, 10021
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Ohio
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Beachwood, Ohio, Verenigde Staten, 44122
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73103
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
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Texas
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Houston, Texas, Verenigde Staten, 77096
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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. |
Andere namen:
De deelnemers moesten minimaal 6 weken voorafgaand aan hun SSRI zijn geweest en moesten gedurende het hele onderzoek hun stabiele dosis blijven gebruiken
Andere namen:
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Experimenteel: 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. |
Andere namen:
De deelnemers moesten minimaal 6 weken voorafgaand aan hun SSRI zijn geweest en moesten gedurende het hele onderzoek hun stabiele dosis blijven gebruiken
Andere namen:
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Placebo-vergelijker: 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. |
De deelnemers moesten minimaal 6 weken voorafgaand aan hun SSRI zijn geweest en moesten gedurende het hele onderzoek hun stabiele dosis blijven gebruiken
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Verandering van randomisatie naar week 8 in de EuroQol Questionnaire-5 Dimension (EQ-5D)
Tijdsspanne: Randomisatie, 8 weken
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De EQ-5D Visual Analog Scale is een generiek, multidimensionaal, gezondheidsgerelateerd instrument voor kwaliteit van leven.
De algehele score voor de gezondheidstoestand is zelfgerapporteerd met behulp van een visueel analoge schaal, gemarkeerd op een schaal van 0 tot 100, waarbij 0 staat voor de slechtst denkbare gezondheidstoestand en 100 voor de best denkbare gezondheidstoestand.
Least Squares (LS)-gemiddelden werden berekend met behulp van Mixed Model Repeated Measures (MMRM) aanpassing voor behandeling, onderzoeker, bezoek, baselinescore, behandeling per bezoek en baselinescore per bezoek.
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Randomisatie, 8 weken
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Verandering van randomisatie naar week 8 in bloeddruk
Tijdsspanne: Randomisatie, 8 weken
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Bloeddrukmetingen werden verzameld wanneer de deelnemer in een zittende positie was.
Drie metingen van de bloeddruk in zittende houding, verzameld met tussenpozen van ongeveer 1 minuut bij elk bezoek, werden gemiddeld en gebruikt als waarde voor het bezoek.
Least Squares (LS)-gemiddelden werden berekend met behulp van Mixed Model Repeated Measures (MMRM)-aanpassingen voor behandeling, onderzoeker, bezoek, baselinewaarde, behandeling per bezoek en baselinewaarde per bezoek.
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Randomisatie, 8 weken
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Wijziging van randomisatie naar week 8 in pulsfrequentie
Tijdsspanne: Randomisatie, 8 weken
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Polsmetingen werden verzameld terwijl de deelnemer in een zittende positie was.
Least Squares (LS)-gemiddelden werden berekend met behulp van Mixed Model Repeated Measures (MMRM)-aanpassingen voor behandeling, onderzoeker, bezoek, baselinewaarde, behandeling per bezoek en baselinewaarde per bezoek.
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Randomisatie, 8 weken
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Verandering van randomisatie naar week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individuele items
Tijdsspanne: Randomisatie, 8 weken
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De MADRS is een beoordelingsschaal voor de ernst van depressieve stemmingssymptomen.
De MADRS had een checklist van 10 items (verdriet [schijnbaar], verdriet [gerapporteerd], innerlijke spanning, verminderde slaap, verminderde eetlust, concentratieproblemen, lusteloosheid, onvermogen om te voelen, pessimistische gedachten en zelfmoordgedachten).
Items werden beoordeeld op een schaal van 0 tot 6, voor een totaalscorebereik van 0 (lage ernst van depressieve symptomen) tot 60 (hoge ernst van depressieve symptomen).
Least Squares (LS)-gemiddelden werden berekend met behulp van Mixed Model Repeated Measures (MMRM)-aanpassingen voor behandeling, onderzoeker, bezoek, baseline itemscore, behandeling per bezoek en baseline itemscore per bezoek.
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Randomisatie, 8 weken
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Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Fatigue Associated With Depression (FAsD) Impact Subscale Score
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 up to Week 8
Tijdsspanne: Randomization up to 8 weeks
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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%.
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Randomization up to 8 weeks
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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
Tijdsspanne: Randomization up to 8 weeks
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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%.
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Randomization up to 8 weeks
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Change From Randomization to Week 8 in the Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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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
Tijdsspanne: Randomization up to 8 weeks
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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%.
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Randomization up to 8 weeks
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Change From Randomization to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)
Tijdsspanne: Randomization, 8 weeks
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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
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Randomization, 8 weeks
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Change From Randomization to Week 8 in The Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Percentage of Participants With Treatment-emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Tijdsspanne: Randomization through 8 weeks
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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.
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Randomization through 8 weeks
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Change From Randomization to Week 8 in the Arizona Sexual Experiences (ASEX) Scale
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
Tijdsspanne: Randomization, 8 weeks
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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.
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Randomization, 8 weeks
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Pharmacokinetics: Plasma Concentrations of LY2216684
Tijdsspanne: Pre-randomization, 1 week, 4 weeks, and 8 weeks
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A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.
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Pre-randomization, 1 week, 4 weeks, and 8 weeks
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Medewerkers en onderzoekers
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Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2011
Primaire voltooiing (Werkelijk)
1 augustus 2013
Studie voltooiing (Werkelijk)
1 augustus 2013
Studieregistratiedata
Eerst ingediend
20 augustus 2010
Eerst ingediend dat voldeed aan de QC-criteria
23 augustus 2010
Eerst geplaatst (Schatting)
24 augustus 2010
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 april 2018
Laatste update ingediend die voldeed aan QC-criteria
25 maart 2018
Laatst geverifieerd
1 maart 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Gedragssymptomen
- Psychische aandoening
- Stemmingsstoornissen
- Depressie
- Depressieve stoornis
- Depressieve stoornis, majoor
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Neurotransmitter-opnameremmers
- Membraantransportmodulatoren
- Serotonine agenten
- Serotoninereceptoragonisten
- Serotonine
- Serotonine-opnameremmers
Andere studie-ID-nummers
- 12182
- H9P-MC-LNBQ (Andere identificatie: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .