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 mars 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
1480
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Rab, Croatie, 51280
- 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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Zagreb, Croatie, 10090
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Helsinki, Finlande, 00100
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Joensuu, Finlande, 80100
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Kuopio, Finlande, 70110
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Tampere, Finlande, 33200
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Turku, Finlande, 20100
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Chiba, Japon, 270-0014
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Fukuoka, Japon, 810-0035
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Fukushima, Japon, 961-0021
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Hyogo, Japon, 661-0002
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Kanagawa, Japon, 247-0056
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Tokyo, Japon, 100-0006
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San Juan, Porto Rico, 00918
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Bratislava, Slovaquie, 85101
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Kosice, Slovaquie, 04001
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Michalovce, Slovaquie, SK-071 01
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Rimavska Sobota, Slovaquie, 97901
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Roznava, Slovaquie, 04801
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Horovice, Tchéquie, 268 31
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Hostivice, Tchéquie, 25201
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Kladno, Tchéquie, 27201
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Olomouc, Tchéquie, 77900
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Prague, Tchéquie, 100 00
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Strakonice, Tchéquie, 38601
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Usti Nad Labem, Tchéquie, 400001
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Alabama
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Birmingham, Alabama, États-Unis, 35216
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Arizona
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Phoenix, Arizona, États-Unis, 85032
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California
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Chino, California, États-Unis, 91710
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Glendale, California, États-Unis, 91204
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Imperial, California, États-Unis, 92251
- 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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National City, California, États-Unis, 91950
- 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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Sherman Oaks, California, États-Unis, 91403
- 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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Colorado
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Colorado Springs, Colorado, États-Unis, 80907
- 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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Florida
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Clearwater, Florida, États-Unis, 33761
- 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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Coral Gables, Florida, États-Unis, 33145
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Fort Lauderdale, Florida, États-Unis, 33319
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Tampa, Florida, États-Unis, 33613
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Georgia
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Atlanta, Georgia, États-Unis, 30308
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Illinois
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Hoffman Estates, Illinois, États-Unis, 60169
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Indiana
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Indianapolis, Indiana, États-Unis, 46260
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Kansas
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Prairie Village, Kansas, États-Unis, 66206
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Wichita, Kansas, États-Unis, 67205
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Maryland
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Baltimore, Maryland, États-Unis, 21285
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Massachusetts
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Haverhill, Massachusetts, États-Unis, 01830
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Weymouth, Massachusetts, États-Unis, 02190
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Mississippi
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Flowood, Mississippi, États-Unis, 39232
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Missouri
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O'Fallon, Missouri, États-Unis, 63368
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New York
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Brooklyn, New York, États-Unis, 11235
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New York, New York, États-Unis, 10021
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Ohio
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Beachwood, Ohio, États-Unis, 44122
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73103
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
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Texas
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Houston, Texas, États-Unis, 77096
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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. |
Autres noms:
Les participants devaient avoir pris leur ISRS pendant au moins 6 semaines avant et devaient continuer à prendre leur dose stable tout au long de l'étude
Autres noms:
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Expérimental: 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. |
Autres noms:
Les participants devaient avoir pris leur ISRS pendant au moins 6 semaines avant et devaient continuer à prendre leur dose stable tout au long de l'étude
Autres noms:
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Comparateur placebo: 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. |
Les participants devaient avoir pris leur ISRS pendant au moins 6 semaines avant et devaient continuer à prendre leur dose stable tout au long de l'étude
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Passage de la randomisation à la semaine 8 dans la dimension du questionnaire EuroQol-5 (EQ-5D)
Délai: Randomisation, 8 semaines
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L'échelle visuelle analogique EQ-5D est un instrument de qualité de vie générique, multidimensionnel, lié à la santé.
Le score global de l'état de santé est autodéclaré à l'aide d'une échelle visuelle analogique, notée sur une échelle de 0 à 100, 0 représentant le pire état de santé imaginable et 100 représentant le meilleur état de santé imaginable.
Les moyennes des moindres carrés (LS) ont été calculées à l'aide de mesures répétées de modèle mixte (MMRM) ajustées pour le traitement, l'investigateur, la visite, le score de base, le traitement par visite et le score de base par visite.
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Randomisation, 8 semaines
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Passage de la randomisation à la semaine 8 pour la tension artérielle
Délai: Randomisation, 8 semaines
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Les mesures de pression artérielle ont été recueillies lorsque le participant était en position assise.
Trois mesures de la pression artérielle en position assise recueillies à des intervalles d'environ 1 minute à chaque visite ont été moyennées et utilisées comme valeur pour la visite.
Les moyennes des moindres carrés (LS) ont été calculées à l'aide de mesures répétées de modèles mixtes (MMRM) ajustées pour le traitement, l'investigateur, la visite, la valeur de référence, le traitement par visite et la valeur de référence par visite.
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Randomisation, 8 semaines
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Changement de la randomisation à la semaine 8 du pouls
Délai: Randomisation, 8 semaines
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Les mesures du pouls ont été recueillies lorsque le participant était en position assise.
Les moyennes des moindres carrés (LS) ont été calculées à l'aide de mesures répétées de modèles mixtes (MMRM) ajustées pour le traitement, l'investigateur, la visite, la valeur de référence, le traitement par visite et la valeur de référence par visite.
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Randomisation, 8 semaines
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Changement de la randomisation à la semaine 8 dans les éléments individuels de l'échelle d'évaluation de la dépression de Montgomery-Asberg (MADRS)
Délai: Randomisation, 8 semaines
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Le MADRS est une échelle d'évaluation de la gravité des symptômes de l'humeur dépressive.
Le MADRS avait une liste de contrôle en 10 points (tristesse [apparente], tristesse [rapportée], tension intérieure, sommeil réduit, appétit réduit, difficultés de concentration, lassitude, incapacité à ressentir, pensées pessimistes et pensées suicidaires).
Les items ont été notés sur une échelle de 0 à 6, pour un score total allant de 0 (faible gravité des symptômes dépressifs) à 60 (forte gravité des symptômes dépressifs).
Les moyennes des moindres carrés (LS) ont été calculées à l'aide de mesures répétées de modèle mixte (MMRM) ajustées pour le traitement, l'investigateur, la visite, le score de l'élément de référence, le traitement par visite et le score de l'élément de référence par visite.
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Randomisation, 8 semaines
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Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2011
Achèvement primaire (Réel)
1 août 2013
Achèvement de l'étude (Réel)
1 août 2013
Dates d'inscription aux études
Première soumission
20 août 2010
Première soumission répondant aux critères de contrôle qualité
23 août 2010
Première publication (Estimation)
24 août 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 mars 2018
Dernière vérification
1 mars 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Symptômes comportementaux
- Les troubles mentaux
- Troubles de l'humeur
- La dépression
- Dépression
- Trouble dépressif majeur
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Agents de sérotonine
- Agonistes des récepteurs de la sérotonine
- Sérotonine
- Inhibiteurs de l'absorption de la sérotonine
Autres numéros d'identification d'étude
- 12182
- H9P-MC-LNBQ (Autre identifiant: Eli Lilly and Company)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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