A Study in Depression and Associated Painful Physical Symptoms
10 de enero de 2012 actualizado por: Eli Lilly and Company
Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
527
Fase
- Fase 4
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
-
-
California
-
Sherman Oaks, California, Estados Unidos, 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.
-
-
Connecticut
-
Cromwell, Connecticut, Estados Unidos, 06416
- 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.
-
-
Florida
-
Fort Lauderdale, Florida, Estados Unidos, 33319
- 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.
-
Orlando, Florida, Estados Unidos, 32806
- 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.
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30308
- 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.
-
-
Illinois
-
Hoffman Estates, Illinois, Estados Unidos, 60194
- 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.
-
Springfield, Illinois, Estados Unidos, 62711
- 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.
-
-
Indiana
-
Evansville, Indiana, Estados Unidos, 47714
- 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.
-
-
Kentucky
-
Florence, Kentucky, Estados Unidos, 41042
- 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.
-
-
Louisiana
-
Lake Charles, Louisiana, Estados Unidos, 70601
- 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.
-
-
Massachusetts
-
Belmont, Massachusetts, Estados Unidos, 02478
- 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.
-
Boston, Massachusetts, Estados Unidos, 02135
- 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.
-
-
Michigan
-
Troy, Michigan, Estados Unidos, 48083
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New Jersey
-
Toms River, New Jersey, Estados Unidos, 08755
- 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.
-
Willingboro, New Jersey, Estados Unidos, 08046
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New York
-
Brooklyn, New York, Estados Unidos, 11235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Rochester, New York, Estados Unidos, 14618
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Staten Island, New York, Estados Unidos, 10305
- 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.
-
-
Ohio
-
Beachwood, Ohio, Estados Unidos, 44122
- 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.
-
Toledo, Ohio, Estados Unidos, 43623
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73109
- 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.
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97210
- 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.
-
Salem, Oregon, Estados Unidos, 97301
- 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.
-
-
Pennsylvania
-
Allentown, Pennsylvania, Estados Unidos, 18104
- 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.
-
Media, Pennsylvania, Estados Unidos, 19063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Philadelphia, Pennsylvania, Estados Unidos, 19107
- 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.
-
-
Rhode Island
-
Lincoln, Rhode Island, Estados Unidos, 02865
- 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.
-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38119
- 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.
-
-
Texas
-
Wichita Falls, Texas, Estados Unidos, 76309
- 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.
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23230
- 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.
-
-
Washington
-
Bellevue, Washington, Estados Unidos, 98007
- 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.
-
-
Wisconsin
-
Middleton, Wisconsin, Estados Unidos, 53562
- 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.
-
-
-
-
-
Caguas, Puerto Rico, 00725
- 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.
-
San Juan, Puerto Rico, 00926
- 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.
-
-
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
Key Inclusion Criteria:
- Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20 during the Screening Phase
- At least 1 previous episode of depression
- Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question
- A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 during the Screening Phase
- Written informed consent
Key Exclusion Criteria:
- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
- Have previously completed or withdrawn from this study or any other study investigating duloxetine (unless no study drug was received)
- Women of child-bearing potential who are not using a medically accepted means of contraception
- Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
- Have a history of alcohol abuse and/or substance abuse or dependence within 1 year prior to being screened for the study
- Have any prior history of bipolar disorder, psychosis, or schizophrenia
- Have an Axis II disorder that would interfere with study compliance
- Lack of response of any episode of major depression (lifetime of subject) to two or more adequate courses of antidepressant therapy, at a clinically appropriate dose for at least 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment resistant depression
- Have previously received treatment of MDD or Generalized Anxiety Disorder (GAD) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine
- Diagnosis of acute liver injury or severe cirrhosis
- Uncontrolled narrow-angle glaucoma
- Positive urine drug screen for any substance of abuse
- Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study
- History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
- Requires continuous use of analgesics for 6 or more months because of chronic pain
- Has pain of a known origin
- Meets criteria for fibromyalgia as defined by the American College of Rheumatology
- Experiences greater than or equal to 1 migraine headache per week
- Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year prior to being screened for the study
- Initiating, changing, or stopping psychotherapy within 6 weeks prior to being screened for the study or at any time during the study
- Investigator or subject anticipates initiating, changing, or stopping non-pharmacologic or alternative therapies for painful physical symptoms at any time during the study
- Are taking any excluded medications within 7 days prior to randomization with the exception of fluoxetine which cannot be taken within 30 days prior to randomization
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization or have the potential need to use an MAOI during the study or within 5 days after discontinuation of study drug
- Abnormal thyroid stimulating hormone
- Has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
|
Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.
|
|
Experimental: Duloxetina
|
Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks.
Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
Periodo de tiempo: Day 1 through 8 weeks
|
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
The overall change is based on the estimated main treatment effect.
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
|
Day 1 through 8 weeks
|
|
Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
Periodo de tiempo: Baseline, 8 weeks
|
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
|
Baseline, 8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cambio desde el inicio en la escala de discapacidad de Sheehan (SDS) Puntajes totales y de ítems en la semana 8
Periodo de tiempo: Línea de base, 8 semanas
|
SDS es completado por el participante; utilizado para evaluar el efecto de los síntomas del participante en su vida laboral/social/familiar.
Las puntuaciones totales oscilan entre 0 y 30; los valores más altos indican una mayor interrupción en la vida laboral/social/familiar del participante.
La puntuación de cada elemento varía de 0 a 10; los valores más altos indican una mayor interrupción en la vida laboral/escolar del participante (elemento 1), la vida social/actividades de ocio (elemento 2) o la vida familiar/responsabilidades del hogar (elemento 3).
El valor medio de LS se ajustó por tratamiento, investigador, visita, línea base, interacción tratamiento*visita e interacción línea base*visita.
|
Línea de base, 8 semanas
|
|
Cambio desde el inicio en las puntuaciones de gravedad e interferencia del Inventario breve del dolor (BPI-S/BPI-I) en la semana 8
Periodo de tiempo: Línea de base, 8 semanas
|
Mide la severidad del dolor y la interferencia en la función.
Puntuaciones de gravedad: 0 (sin dolor) a 10 (dolor intenso) en cada pregunta.
Puntuaciones de interferencia: 0 (no interfiere) a 10 (interfiere completamente) en cada pregunta que evalúa la interferencia del dolor en las últimas 24 horas para la actividad general, el estado de ánimo, la capacidad para caminar, el trabajo normal, las relaciones con otras personas, el sueño y el disfrute de la vida.
Interferencia promedio = promedio de puntajes no faltantes de elementos de interferencia individuales.
Valor medio de LS ajustado por tratamiento, investigador, visita, línea base, interacción tratamiento*visita e interacción línea base*visita.
|
Línea de base, 8 semanas
|
|
Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8
Periodo de tiempo: Baseline, up to 8 weeks
|
The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Remission is defined as achieving a MADRS total score ≤12.
|
Baseline, up to 8 weeks
|
|
Percentage of Participants Achieving Remission up to Week 8
Periodo de tiempo: Up to 8 weeks
|
The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).
|
Up to 8 weeks
|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4
Periodo de tiempo: Baseline, 4 weeks
|
The MADRS is a rating scale for severity of depressive mood and symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
|
Baseline, 4 weeks
|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2
Periodo de tiempo: Baseline, 2 weeks
|
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
|
Baseline, 2 weeks
|
|
Patient Global Impression of Improvement (PGI-I) Score at Week 8
Periodo de tiempo: 8 weeks
|
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment.
The score ranges from 1 (very much better) to 7 (very much worse).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.
|
8 weeks
|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase
Periodo de tiempo: Baseline through 8 weeks
|
The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Number of participants with suicidal behaviors, ideations, and acts are provided.
Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide.
Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Suicidal acts: a "yes" answer to actual attempt or completed suicide.
|
Baseline through 8 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cambio desde el inicio en la frecuencia del pulso hasta la semana 8
Periodo de tiempo: Línea de base, hasta la semana 8
|
El cambio desde el inicio en la frecuencia del pulso en la semana 8 es el análisis principal. Para el análisis primario de la frecuencia del pulso, el valor medio de mínimos cuadrados (LS) se ajustó para el tratamiento, el investigador, la línea base, la interacción tratamiento*visita y la interacción línea base*visita. El cambio desde el inicio en la frecuencia del pulso hasta la semana 8 es el análisis secundario. El valor medio de LS se ajustó para el tratamiento, el investigador y el valor inicial. |
Línea de base, hasta la semana 8
|
|
Cambio desde el inicio en la presión arterial sistólica (PAS) y la presión arterial diastólica (PAD) hasta la semana 8
Periodo de tiempo: Línea de base, hasta la semana 8
|
El cambio desde el inicio en la PAS y la PAD en la semana 8 es el análisis principal. Para el análisis primario de la PAS y la PAD, el valor medio de mínimos cuadrados (LS) se ajustó para el tratamiento, el investigador, la línea base, la interacción tratamiento*visita y la interacción línea base*visita. El cambio desde el inicio en la PAS y la PAD hasta la semana 8 es el análisis secundario. El valor medio de LS se ajustó para el tratamiento, el investigador y el valor inicial. |
Línea de base, hasta la semana 8
|
|
Cambio desde el inicio en el peso hasta la semana 8
Periodo de tiempo: Línea de base, hasta la semana 8
|
El cambio desde el inicio en el peso en la semana 8 es el análisis principal. Para el análisis primario de peso, el valor medio de mínimos cuadrados (LS) se ajustó para el tratamiento, el investigador, la línea base, la interacción tratamiento*visita y la interacción línea base*visita. El cambio desde el inicio en el peso hasta la semana 8 es el análisis secundario. El valor medio de LS se ajustó para el tratamiento, el investigador y el valor inicial. |
Línea de base, hasta la semana 8
|
|
Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine
Periodo de tiempo: Baseline through 8 weeks
|
Laboratory assessment of creatinine during the double-blind treatment phase.
Normal creatinine ranges for males are 40.00
micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high).
Normal creatinine ranges for females are 31.00
µmol/L (low) to 101.00 µmol/L (high).
|
Baseline through 8 weeks
|
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
- Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.
- Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Hann D, Marangell LB. Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study. Curr Med Res Opin. 2011 Oct;27(10):1859-67. doi: 10.1185/03007995.2011.609540. Epub 2011 Aug 12.
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 2010
Finalización primaria (Actual)
1 de marzo de 2011
Finalización del estudio (Actual)
1 de marzo de 2011
Fechas de registro del estudio
Enviado por primera vez
16 de febrero de 2010
Primero enviado que cumplió con los criterios de control de calidad
16 de febrero de 2010
Publicado por primera vez (Estimar)
18 de febrero de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de febrero de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
10 de enero de 2012
Última verificación
1 de enero de 2012
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
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Drogas psicotropicas
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes antidepresivos
- Agentes de dopamina
- Inhibidores de la recaptación de serotonina y noradrenalina
- Clorhidrato de duloxetina
Otros números de identificación del estudio
- 13630
- F1J-US-HMGU (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. .