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 de marzo de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1480
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Horovice, Chequia, 268 31
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Hostivice, Chequia, 25201
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Kladno, Chequia, 27201
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Olomouc, Chequia, 77900
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Prague, Chequia, 100 00
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Strakonice, Chequia, 38601
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Usti Nad Labem, Chequia, 400001
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Rab, Croacia, 51280
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Zagreb, Croacia, 10090
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Bratislava, Eslovaquia, 85101
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Kosice, Eslovaquia, 04001
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Michalovce, Eslovaquia, SK-071 01
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Rimavska Sobota, Eslovaquia, 97901
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Roznava, Eslovaquia, 04801
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Alabama
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Birmingham, Alabama, Estados Unidos, 35216
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Arizona
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Phoenix, Arizona, Estados Unidos, 85032
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California
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Chino, California, Estados Unidos, 91710
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Glendale, California, Estados Unidos, 91204
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Imperial, California, Estados Unidos, 92251
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National City, California, Estados Unidos, 91950
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Sherman Oaks, California, Estados Unidos, 91403
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80907
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Florida
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Clearwater, Florida, Estados Unidos, 33761
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Coral Gables, Florida, Estados Unidos, 33145
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Fort Lauderdale, Florida, Estados Unidos, 33319
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Tampa, Florida, Estados Unidos, 33613
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
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Illinois
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Hoffman Estates, Illinois, Estados Unidos, 60169
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46260
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Kansas
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Prairie Village, Kansas, Estados Unidos, 66206
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Wichita, Kansas, Estados Unidos, 67205
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Maryland
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Baltimore, Maryland, Estados Unidos, 21285
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Massachusetts
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Haverhill, Massachusetts, Estados Unidos, 01830
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Weymouth, Massachusetts, Estados Unidos, 02190
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Mississippi
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Flowood, Mississippi, Estados Unidos, 39232
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Missouri
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O'Fallon, Missouri, Estados Unidos, 63368
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New York
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Brooklyn, New York, Estados Unidos, 11235
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New York, New York, Estados Unidos, 10021
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Ohio
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Beachwood, Ohio, Estados Unidos, 44122
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
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Texas
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Houston, Texas, Estados Unidos, 77096
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Helsinki, Finlandia, 00100
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Joensuu, Finlandia, 80100
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Kuopio, Finlandia, 70110
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Tampere, Finlandia, 33200
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Turku, Finlandia, 20100
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Chiba, Japón, 270-0014
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Fukuoka, Japón, 810-0035
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Fukushima, Japón, 961-0021
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Hyogo, Japón, 661-0002
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Kanagawa, Japón, 247-0056
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Tokyo, Japón, 100-0006
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San Juan, Puerto Rico, 00918
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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. |
Otros nombres:
Los participantes deberían haber estado tomando ISRS durante al menos 6 semanas antes y debían continuar con su dosis estable durante todo el estudio.
Otros nombres:
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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. |
Otros nombres:
Los participantes deberían haber estado tomando ISRS durante al menos 6 semanas antes y debían continuar con su dosis estable durante todo el estudio.
Otros nombres:
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Comparador de placebos: 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. |
Los participantes deberían haber estado tomando ISRS durante al menos 6 semanas antes y debían continuar con su dosis estable durante todo el estudio.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cambio de la aleatorización a la semana 8 en la dimensión del cuestionario EuroQol-5 (EQ-5D)
Periodo de tiempo: Aleatorización, 8 semanas
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La escala analógica visual EQ-5D es un instrumento genérico, multidimensional, relacionado con la salud y de calidad de vida.
La puntuación general del estado de salud se autoinforma utilizando una escala analógica visual, marcada en una escala de 0 a 100, donde 0 representa el peor estado de salud imaginable y 100 representa el mejor estado de salud imaginable.
Las medias de mínimos cuadrados (LS) se calcularon utilizando medidas repetidas de modelos mixtos (MMRM) ajustando el tratamiento, el investigador, la visita, la puntuación inicial, el tratamiento por visita y la puntuación inicial por visita.
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Aleatorización, 8 semanas
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Cambio de la aleatorización a la semana 8 en la presión arterial
Periodo de tiempo: Aleatorización, 8 semanas
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Las mediciones de la presión arterial se recogieron cuando el participante estaba sentado.
Se promediaron tres mediciones de la presión arterial en posición sentada recopiladas a intervalos de aproximadamente 1 minuto en cada visita y se usaron como el valor de la visita.
Las medias de mínimos cuadrados (LS) se calcularon utilizando medidas repetidas de modelos mixtos (MMRM) ajustando por tratamiento, investigador, visita, valor inicial, tratamiento por visita y valor inicial por visita.
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Aleatorización, 8 semanas
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Cambio de la aleatorización a la semana 8 en la frecuencia del pulso
Periodo de tiempo: Aleatorización, 8 semanas
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Las mediciones del pulso se recogieron cuando el participante estaba sentado.
Las medias de mínimos cuadrados (LS) se calcularon utilizando medidas repetidas de modelos mixtos (MMRM) ajustando por tratamiento, investigador, visita, valor inicial, tratamiento por visita y valor inicial por visita.
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Aleatorización, 8 semanas
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Cambio de la aleatorización a la semana 8 en los elementos individuales de la escala de calificación de depresión de Montgomery-Asberg (MADRS)
Periodo de tiempo: Aleatorización, 8 semanas
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La MADRS es una escala de calificación para la gravedad de los síntomas del estado de ánimo depresivo.
La MADRS tenía una lista de verificación de 10 elementos (tristeza [aparente], tristeza [informada], tensión interna, sueño reducido, apetito reducido, dificultades de concentración, lasitud, incapacidad para sentir, pensamientos pesimistas y pensamientos suicidas).
Los ítems se calificaron en una escala de 0 a 6, para un rango de puntuación total de 0 (gravedad baja de los síntomas depresivos) a 60 (gravedad alta de los síntomas depresivos).
Las medias de mínimos cuadrados (LS) se calcularon utilizando medidas repetidas de modelos mixtos (MMRM) ajustando el tratamiento, el investigador, la visita, la puntuación inicial del elemento, el tratamiento por visita y la puntuación inicial del elemento por visita.
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Aleatorización, 8 semanas
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Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2011
Finalización primaria (Actual)
1 de agosto de 2013
Finalización del estudio (Actual)
1 de agosto de 2013
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2010
Primero enviado que cumplió con los criterios de control de calidad
23 de agosto de 2010
Publicado por primera vez (Estimar)
24 de agosto de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de abril de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
25 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Trastornos del estado de ánimo
- Depresión
- Desorden depresivo
- Trastorno Depresivo Mayor
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de serotonina
- Agonistas del receptor de serotonina
- Serotonina
- Inhibidores de la captación de serotonina
Otros números de identificación del estudio
- 12182
- H9P-MC-LNBQ (Otro identificador: Eli Lilly and Company)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .