Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1) (PAGE-1_AG1)
A Six-month Study of the Genecept Assay vs. Treatment as Usual to Evaluate Efficacy of Using Assay Guided Treatment in Outpatient Adults With Treatment Resistant Depression
One-third or more of individuals treated for major depressive disorder (MDD) do not experience remission of symptoms despite at least two adequate antidepressant trials. Such treatment-resistant depression (TRD) contributes disproportionately to the tremendous costs of MDD, in terms of health care costs, functional impairment, and diminished quality of life.
The promise of personalized medicine for individuals at high risk for TRD is apparent. If these individuals could be recognized early in their disease course, they could be triaged to more intensive or targeted interventions to improve their likelihood of remission. With the proliferation of treatment options in MDD, at present individuals can spend months or years in and out of treatment before receiving these next-step treatments.
At present, no clinical or biomarker-based tool has been shown to assist in matching patients with treatments most likely to be effective for them. The Genecept Assay offers the possibility of "Personalized Medicine" in psychiatry. Clinicians may find this additional genetic information can lead to optimized treatment plans for individual patients. Before such an assay can be widely applied clinically, it is necessary to demonstrate that this tool usefully impacts treatment outcomes.
This study will examine the potential impact of the assay in terms of depression severity at 3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate of its potential to change clinician behavior and improve patient quality of life. Further measures will also allow for refinement of the assay to maximize patient and clinician satisfaction, and estimate the potential savings associated with deployment of this assay in real-world clinical settings.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37228
- Centerstone
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- age 18-65
- written informed consent
- diagnosis of non-psychotic major depression as determined by study
- clinician/current medical prescriber, and mood disorder diagnosis confirmed by PHQ-9
- QIDS-SR score of at least 10 (i.e., moderate depression) at initial visit
- failure of at least 1 prior adequate trial of a standard antidepressant (by ATRQ criteria - i.e., 6 weeks at adequate dose)
Exclusion Criteria:
- psychotic features in the current episode, based upon clinical assessment
- 4 or more failed pharmacologic interventions in the current major depressive episode [response rates for these subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects]
- current substance use disorder other than nicotine which based upon clinical assessment requires inpatient or outpatient detoxification
- pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
- women who are breastfeeding
- serious suicide or homicide risk, as assessed by evaluating clinician
- other unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests
- patients who have taken an investigational psychotropic drug within the last 3 months
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Treatment as usual (TAU)
Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
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Experimental: Genecept Assay
Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
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Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months
Prazo: 6 months
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To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months Add:
Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression |
6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.
Prazo: one week
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Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group).
Clinician choices will be compared.
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one week
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Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
Prazo: baseline, 3, 6 months
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To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.
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baseline, 3, 6 months
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Cost
Prazo: 6 months
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To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.
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6 months
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Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey
Prazo: 6 months
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To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Rachel Dicker, PharmD, Genomind, LLC
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 (Real)
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
Outros números de identificação do estudo
- AG1-0001/2
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Ensaios clínicos em Transtorno Depressivo Maior
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Government College University FaisalabadAinda não está recrutandoPacientes com Perturbação Depressiva MajorPaquistão
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Assiut UniversityAinda não está recrutandoComposição corporal em talassemia major
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Centre Hospitalier Universitaire de Saint EtienneBayerRescindido
-
San Rocco TherapeuticsAtivo, não recrutandoDiagnóstico confirmado de ß-talassemia MajorItália
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Fondazione Policlinico Universitario Agostino Gemelli...Ainda não está recrutandoCirrose hepática | Hipertensão Portal Não Cirrótica | Hipertensão portal relacionada à cirrose | Elastografia Ultrassônica | Ultrassom com contraste | Porto-sinusoidal Vascular Liver DisorderItália
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Aswan UniversityRecrutamentoHemostasia Obstétrica | Hemólise Intravascular | Hemorragia Obstétrica Major | Transfusão por Seringagem Manual | Transfusão com Bolsa de Pressão PneumáticaEgito
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First Affiliated Hospital of Guangxi Medical UniversityLiuzhou Workers Hospital; Peking University People's Hospital; Ruijin Hospital; Xinqiao... e outros colaboradoresConcluído
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Bioray LaboratoriesFirst Affiliated Hospital of Guangxi Medical UniversitySuspenso
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National Taiwan University HospitalRecrutamentoTalassemia MajorTaiwan
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Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie...Ativo, não recrutando
Ensaios clínicos em Genecept Assay
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Genomind, LLCMedpace, Inc.ConcluídoTranstorno Depressivo MaiorEstados Unidos
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Genomind, LLCRetiradoTranstorno Depressivo MaiorEstados Unidos
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Genomind, LLCConcluídoDistúrbio de ansiedade generalizada | Depressão resistente ao tratamentoEstados Unidos
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Seattle Institute for Biomedical and Clinical ResearchGenomind, LLCConcluídoTeste farmacogenéticoEstados Unidos
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University of TorontoUniversity Health Network, TorontoRescindido
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Institute of Oncology LjubljanaConcluídoCâncer de Pulmão de Células Não PequenasEslovênia
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Mayo ClinicConcluídoVírus do Papiloma HumanoEstados Unidos
-
National Cancer Institute (NCI)RecrutamentoCâncer de Mama Anatômico Estágio II AJCC v8 | Câncer de Mama Anatômico Estágio IIIA AJCC v8 | Câncer de Mama Anatômico Estágio IIIC AJCC v8 | Carcinoma de mama HER2-negativo | Carcinoma de mama com receptor de estrogênio positivoEstados Unidos