A Comparison of Tolerability and Efficacy of Different Doses of Duloxetine for the Treatment of Major Depressive Disorder
24 de janeiro de 2007 atualizado por: Eli Lilly and Company
A Comparison of Duloxetine Dosing Strategies in The Treatment of Patients With Major Depression
The purpose of this study is to compare the tolerability and efficacy of different doses of duloxetine in patients with major depressive disorder.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição
640
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Arkansas
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Little Rock, Arkansas, Estados Unidos
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Florida
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Coral Springs, Florida, Estados Unidos
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Jacksonville, Florida, Estados Unidos
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Miami, Florida, Estados Unidos
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Port Charlotte, Florida, Estados Unidos
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Idaho
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Boise, Idaho, Estados Unidos
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Illinois
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Edwardsville, Illinois, Estados Unidos
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Indiana
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Lafayette, Indiana, Estados Unidos
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Terre Haute, Indiana, Estados Unidos
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Louisiana
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Metairie, Louisiana, Estados Unidos
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New Orleans, Louisiana, Estados Unidos
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Maryland
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Glen Burnie, Maryland, Estados Unidos
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Massachusetts
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Belmont, Massachusetts, Estados Unidos
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Missouri
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St. Louis, Missouri, Estados Unidos
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New Jersey
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Clementon, New Jersey, Estados Unidos
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Princeton, New Jersey, Estados Unidos
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New Mexico
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Albuquerque, New Mexico, Estados Unidos
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New York
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New York, New York, Estados Unidos
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Olean, New York, Estados Unidos
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Oregon
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Eugene, Oregon, Estados Unidos
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Portland, Oregon, Estados Unidos
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos
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Tennessee
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Memphis, Tennessee, Estados Unidos
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Texas
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Houston, Texas, Estados Unidos
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Lake Jackson, Texas, Estados Unidos
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Virginia
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Charlottesville, Virginia, Estados Unidos
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Midlothian, Virginia, Estados Unidos
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Richmond, Virginia, Estados Unidos
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Washington
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Seattle, Washington, Estados Unidos
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Wisconsin
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Brown Deer, Wisconsin, Estados Unidos
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West Allis, Wisconsin, Estados Unidos
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Outpatients at least 18 years of age (male and/or female) who meet criteria for major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual for Mental Disorders Fourth Edition Text Revision (DSM-IV-TR). Patients may have comorbid Anxiety Disorders, except for Obsessive Compulsive Disorder
- Tests negative for pregnancy at the time of enrollment based on a serum pregnancy test and agrees to use a reliable method of birth control (for example, use of oral contraceptives or Norplant a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of study drug.
- Hamilton Depression Rating 17 Item Scale (HAMD-17) greater than 15 at Visits 1 and 2.
Exclusion Criteria:
- Have any current Axis I disorder other than major depressive disorder (MDD), dysthymia, or any anxiety disorder; however, obsessive-compulsive disorder is excluded.
- Have any previous or current diagnosis of bipolar disorder, obsessive-compulsive disorder, schizophrenia, or other psychotic disorders.
- Lack of response of the current episode of major depression to two or more adequate courses of antidepressant therapy at clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression.
- DSM-IV-TR-defined history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine.
- Patients judged to be at serious suicidal risk in the opinion of the investigator.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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The primary objective in the acute phase of this study is to compare the incidence of treatment-emergent nausea
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for patients initially dosed at duloxetine 30 mg QD
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(once-daily), versus duloxetine 60 mg QD.
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The primary objective in the extension phase of this study is to compare efficacy in patients not meeting response criteria during the acute phase for patients dosed at duloxetine 60 mg QD versus duloxetine 120 mg QD.
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Medidas de resultados secundários
Medida de resultado |
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The secondary objective of greatest importance is to compare the incidence of treatment-emergent nausea
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(as defined for the primary objective) for patients
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initially dosed at duloxetine 30 mg QD, versus duloxetine 30 mg BID (twice-daily).
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Additional secondary objectives include comparing the three initial dosing groups in regards to:Mean changes from baseline in the category total scores and individual items scores of the AMDP-5
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The incidence and severity of adverse events using rates of spontaneously reported treatment-emergent adverse events, rates of discontinuations due to
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adverse events, categorical changes in AMDP-5 items, mean changes and categorical changes in vital signs
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as well as mean changes and rates of abnormal laboratory analytes
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Mean changes from baseline in the HAMD17 total score, HAMD subscales, HAMD17 individual items, 30-item Inventory of Depressive Symptoms,
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Clinician Rated (IDS-30) total score and individual items, Brief Pain Inventory items and interference
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total score, Visual Analog Scales for pain, Clinical Global Impressions of Severity (CGI-Severity), Post-baseline means
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on the Patient's Global Impression of Improvement (PGI-I), Remission rates (HAMD17 total score of less than 7),
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and response rates (greater than 50% decrease from baseline on the HAMD17 total score).
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- Sexual dysfunction, as measured by categorical changes (same, better, worse) and presence vs. absence, based on the patient global assessment of sexual functioning.
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Time to onset of action in depression (30% improvement in Maier Subscale of HAMD) and painful physical symptoms (30% improvement in as measure by the BPI interference total score).
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Perlis RH, Fijal B, Dharia S, Houston JP. Pharmacogenetic investigation of response to duloxetine treatment in generalized anxiety disorder. Pharmacogenomics J. 2013 Jun;13(3):280-5. doi: 10.1038/tpj.2011.62. Epub 2012 Jan 17.
- Kornstein SG, Dunner DL, Meyers AL, Whitmyer VG, Mallinckrodt CH, Wohlreich MM, Detke MJ, Hollandbeck MS, Greist JH. A randomized, double-blind study of increasing or maintaining duloxetine dose in patients without remission of major depressive disorder after initial duloxetine therapy. J Clin Psychiatry. 2008 Sep;69(9):1383-92. doi: 10.4088/jcp.v69n0905.
- Whitmyer VG, Dunner DL, Kornstein SG, Meyers AL, Mallinckrodt CH, Wohlreich MM, Gonzales JS, Greist JH. A comparison of initial duloxetine dosing strategies in patients with major depressive disorder. J Clin Psychiatry. 2007 Dec;68(12):1921-30. doi: 10.4088/jcp.v68n1213.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2004
Conclusão do estudo
1 de janeiro de 2006
Datas de inscrição no estudo
Enviado pela primeira vez
12 de setembro de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de setembro de 2005
Primeira postagem (Estimativa)
19 de setembro de 2005
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de janeiro de 2007
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de janeiro de 2007
Última verificação
1 de janeiro de 2007
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Sintomas Comportamentais
- Transtornos Mentais, Desordem Mental
- Transtornos de Humor
- Depressão
- Desordem depressiva
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Drogas Psicotrópicas
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Antidepressivos
- Agentes de Dopamina
- Inibidores da Recaptação de Serotonina e Noradrenalina
- Cloridrato de Duloxetina
Outros números de identificação do estudo
- 8950
- F1D-US-HMDR
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 .