Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder
The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder.
The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder. Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy. This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period. Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study. Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.
Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder.
Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy.
This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week s safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period.
Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study.
Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
-
-
-
Ibaraki, Japão
-
Tokyo, Japão
-
-
Chiba
-
Inzai-shi, Chiba, Japão
-
Noda-City, Chiba, Japão
-
-
Fukuoka
-
Fukuoka-city, Fukuoka, Japão
-
Kitakyushu-shi, Fukuoka, Japão
-
-
Gunma
-
Annaka-shi, Gunma, Japão
-
Fujioka-shi, Gunma, Japão
-
Takasaki-shi, Gunma, Japão
-
-
Hiroshima
-
Hatsukaichi-shi, Hiroshima, Japão
-
Hiroshima-shi, Hiroshima, Japão
-
-
Hokkaido
-
Sapporo-Shi, Hokkaido, Japão
-
-
Hyogo
-
Amagasaki-shi, Hyogo, Japão
-
Kobe-shi, Hyogo, Japão
-
-
Kanagawa
-
Fujisawa-shi, Kanagawa, Japão
-
Kawasaki-shi, Kanagawa, Japão
-
Sagamihara-shi, Kanagawa, Japão
-
Yokohama-shi, Kanagawa, Japão
-
-
Kita-ku
-
Osaka-shi, Kita-ku, Japão
-
-
Kumamoto
-
Kumamoto-shi, Kumamoto, Japão
-
-
Kyoto
-
Kyoto-shi, Kyoto, Japão
-
-
Okayama
-
Kurashiki-shi, Okayama, Japão
-
-
Osaka
-
Osaka-shi, Osaka, Japão
-
-
Saitama
-
Fukaya-shi, Saitama, Japão
-
Saitama-city, Saitama, Japão
-
-
Tochigi
-
Utsunomiya-shi, Tochigi, Japão
-
-
Tokushima
-
Anan-shi, Tokushima, Japão
-
Tokushisma-shi, Tokushima, Japão
-
-
Tokyo
-
Hachioji-shi, Tokyo, Japão
-
Katsushika-ku, Tokyo, Japão
-
Musashino-shi, Tokyo, Japão
-
-
Yamagata
-
Nanyo-shi, Yamagata, Japão
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- The subject suffers from Major Depressive Disorder (MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).
- The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.
- The subject has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.
- The subject has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits
Exclusion Criteria:
The subject has one or more of the following conditions:
- Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR. A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
- Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.).
- Any DSM-IV-TR axis II disorder that might compromise the study.
- The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- The subject is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the Screening and Baseline Visit, or has attempted suicide within 6 months prior to the Screening Visit.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Vortioxetine 5 mg
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
|
Vortioxetina comprimidos
Outros nomes:
|
|
Experimental: Vortioxetine 10 mg
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
|
Vortioxetina comprimidos
Outros nomes:
|
|
Comparador de Placebo: Placebo
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
|
Vortioxetine placebo
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment
Prazo: Baseline, Week 8
|
MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms.
A negative change from Baseline indicates that symptoms have improved.
An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.
|
Baseline, Week 8
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Patients With MADRS Response After 8 Weeks of Treatment
Prazo: Baseline, Week 8
|
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms.
Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.
|
Baseline, Week 8
|
|
Percentage of Patients With MADRS Remission After 8 Weeks of Treatment
Prazo: Week 8
|
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms.
Remission is defined as a MADRS Total Score ≤10.
|
Week 8
|
|
Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment
Prazo: Baseline, Week 8
|
The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52.
Higher scores indicate greater severity of depression symptoms.
A negative change from Baseline indicates that symptoms have improved.
ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.
|
Baseline, Week 8
|
|
Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment
Prazo: Baseline, Week 8
|
The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: "Compared to his condition at the start of the study, how much has this patient changed?" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse).
Higher scores indicate greater severity of illness.
Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms.
ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate.
|
Baseline, Week 8
|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment
Prazo: Baseline, Week 8
|
The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30.
Higher scores indicate greater severity of impairment.
A negative change from Baseline indicates that symptoms have improved.
ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.
|
Baseline, Week 8
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sintomas Comportamentais
- Transtornos Mentais, Desordem Mental
- Transtornos de Humor
- Depressão
- Desordem depressiva
- Transtorno Depressivo Maior
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Depressores do Sistema Nervoso Central
- Agentes Tranquilizantes
- Drogas Psicotrópicas
- Inibidores de Captação de Serotonina
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Agentes de Serotonina
- Antidepressivos
- Agonistas do Receptor de Serotonina 5-HT1
- Agonistas de Receptores de Serotonina
- Antagonistas da Serotonina
- Agentes Anti-Ansiedade
- Antagonistas do Receptor de Serotonina 5-HT3
- Vortioxetina
Outros números de identificação do estudo
- LuAA21004/CCT-003
- U1111-1120-9277 (Identificador de registro: WHO)
- JapicCTI-111492 (Identificador de registro: JapicCTI)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .