Risks for Insulin Resistance and Metabolic Syndrome Between Major Depressive Disorder (MDD) or MDD With Psychotic Features
10 de fevereiro de 2017 atualizado por: John D. Matthews, Massachusetts General Hospital
Comparative Risks for Insulin Resistance and Metabolic Syndrome (MS) Among Hospitalized Patients With Major Depressive Disorder With (MDpsy) or Without (MDD) Psychotic Features
Studies have shown that people with certain disorders have an increased risk of developing a condition called Metabolic Syndrome (MS). In this study, the investigators want to learn more about MS among people staying in the hospital for treatment of Major Depressive Disorder (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The investigators also want to learn more about a stress hormone called cortisol that is made in the body. Those who take part in this study will answer some questionnaires, be given some psychiatric interviews, and have some blood taken along with a urine sample.
The investigators believe that patients in the hospital with MDpsy will have higher baseline rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance, compared with MDD alone.
Visão geral do estudo
Status
Rescindido
Descrição detalhada
Metabolic syndrome (MS) is a combination of medical problems that can increase the risk of heart disease and diabetes in some people. People with MS can have some or all of the following:
- High blood glucose
- High blood pressure
- Abdominal obesity
- Low levels of high-density lipoprotein (HDL) cholesterol
- High levels of triglycerides
Some studies have shown that people with certain disorders have a greater risk for developing MS. This may be because of a combination of factors, including but not limited to the type of medications used, age, and whether or not someone smokes. This study will also aim to learn more about a naturally-occurring stress hormone called cortisol that is made in the body.
In order to measure these factors, the following things will occur:
- administer a number of questionnaires
- gather information from medical history
- gather information about current psychiatric mood
- draw blood and collect a urine sample
To study the amount of cortisol in the body, a dexamethasone suppression test (DST) will be given. This test involves taking a single 1mg pill of dexamethasone, a steroid, and numerous blood draws. Like any drug, it has some risks, however it is unlikely any side effects will occur because of the low dose administered.
Tipo de estudo
Observacional
Inscrição (Real)
14
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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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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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 a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Eligible subjects are people who are inpatient in the medical-psychiatric unit at Massachusetts General Hospital.
Included subjects have working diagnosis of major depressive disorder (MDD) or major depressive disorder with psychotic features (MDpsy).
Descrição
Inclusion Criteria:
- Capable of giving informed consent
- DSM-IV TR diagnosis of Major Depressive Disorder with (MDpsy) or without (MDD) Psychotic Features
- Age between 18 and 85, inclusive
- Pre-existing Hyperlipidemia, Hypertension, and Diabetes must be stable with laboratory and clinical results within acceptable range; with or without medication for three months prior to admission
Exclusion Criteria:
- DSM-IV TR diagnosis of: schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, organic mental disorder, substance use dependence including alcohol, that has been active within the past 6 months, acute bereavement, and psychotic disorder not elsewhere classified
- Subjects that meet criteria for substance or alcohol dependence more recently than three months prior to entering the study
- Subjects that meet criteria for substance or alcohol abuse more recently than four weeks prior to entering the study
- Pregnancy
- Unstable or inadequately treated pre-existing hyperlipidemia, hypertension, and diabetes
- Subjects who are involuntarily committed.
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
Coortes e Intervenções
Grupo / Coorte |
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Transtorno Depressivo Maior
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Major Depressive Disorder with Psychotic Features
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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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The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient.
Prazo: Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge
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To preserve statistical power, we will measure insulin as a continuous variable rather than dichotomizing participants into insulin sensitive vs insulin resistant.
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Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The first secondary measure is a fasting lipid panel, including fasting total cholesterol, fasting LDL, fasting HDL, and fasting triglycerides; we want to measure a change in data from admission to discharge
Prazo: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Fasting glucose will be a separate secondary outcome measure; we want to measure a change in data from admission to discharge
Prazo: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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|
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Waist Circumference; we want to measure a change in data from admission to discharge
Prazo: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
|
Waist circumference will be measured once at admission and once at discharge to determine if any changes have occurred throughout time of inpatient hospitalization
|
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
|
|
Urine microalbumin; we want to measure a change in data from admission to discharge
Prazo: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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C-reactive Protein; we want to measure a change in data from admission to discharge
Prazo: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
|
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Homocysteine; we want to measure a change in data from admission to discharge
Prazo: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
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Blood pressure (supine & standing as available)
Prazo: We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
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We will be measuring this continuously throughout inpatient hospitalization, beginning at time of admission
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Cortisol; we want to measure a change in data from admission to discharge
Prazo: Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
|
Cortisol levels will be measured before and after a dexamethasone suppression test is administered at admission and discharge
|
Two separate timepoints during inpatient hospitalization; first within 5 days of admission, and second within 72 hours of scheduled discharge
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 (Real)
1 de janeiro de 2011
Conclusão Primária (Real)
1 de setembro de 2012
Conclusão do estudo (Real)
1 de setembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
15 de fevereiro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de março de 2011
Primeira postagem (Estimativa)
8 de março de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de fevereiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de fevereiro de 2017
Última verificação
1 de fevereiro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sintomas Comportamentais
- Processos Patológicos
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Transtornos de Humor
- Espectro da Esquizofrenia e Outros Transtornos Psicóticos
- Hiperinsulinismo
- Depressão
- Desordem depressiva
- Síndrome
- Doença
- Transtornos Psicóticos
- Síndrome metabólica
- Transtornos Mentais, Desordem Mental
- Resistência a insulina
- Transtorno Depressivo Maior
Outros números de identificação do estudo
- 2009-P-002723
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