História Natural da Depressão, Transtorno Bipolar e Risco de Suicídio
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.
People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.
This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.
Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation....
Visão geral do estudo
Status
Condições
- Sintomas Comportamentais
- Suicídio
- Comportamento autolesivo
- Sintomas Depressivos
- Transtorno Depressivo Maior
- Depressão resistente ao tratamento
- Cetamina
- Mecanismos Moleculares de Ação Farmacológica
- Depressão Unipolar
- Depressão, Bipolar
- Efeitos Fisiológicos das Drogas
- Agentes do Sistema Nervoso Periférico
- Depressores do Sistema Nervoso Central
- Analgésicos
- Agentes Neurotransmissores
- Agentes do Sistema Sensorial
- Anestésicos
- Anestésicos Gerais
- Anestésicos Dissociativos
- Antagonistas de aminoácidos excitatórios
- Agentes de aminoácidos excitatórios
Descrição detalhada
Study Description:
This proposal would collect systematic data on individuals undergoing personalized treatments for depression, bipolar disorder and suicide risk within the Experimental Therapeutics and Pathophysiology Branch (ETPB). The ETPB recruits individuals with treatment-resistant mood disorders from around the country. After research participation, they are often offered a course of standard treatment, tailored to clinical needs, for clinical stabilization and discharge back to non-NIH clinicians. This protocol would allow for clinical ratings in-person and remotely throughout clinical standard treatments, as well as neurobiological procedures at baseline and study termination to identify potential clinical and demographic predictors and biomarkers of treatment response.
Objectives:
The primary objective is to identify predictors of antidepressant treatment response.
The secondary and tertiary objectives are to identify predictors of suicide ideation response to treatment, and biomarkers of antidepressant response to treatment, respectively.
Endpoints:
Primary Endpoint: Score on the Montgomery Asberg Depression Rating Scale
Secondary Endpoint: Score on the Scale for Suicidal Ideation
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Elizabeth D Ballard, Ph.D.
- Número de telefone: (301) 435-9399
- E-mail: elizabeth.ballard@nih.gov
Estude backup de contato
- Nome: Kelly T Hurst, Ph.D.
- Número de telefone: (877) 646-3644
- E-mail: moodresearch@mail.nih.gov
Locais de estudo
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- Recrutamento
- National Institutes of Health Clinical Center
-
Contato:
- Elizabeth Ballard, Ph.D.
- Número de telefone: 301-435-9399
- E-mail: elizabeth.ballard@nih.gov
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients with depression, bipolar disorder, and individuals at elevated suicide risk.
Descrição
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers
- Age 18 years or older
- Able to provide informed consent
- Able to read and write English
EXCLUSION CRITERIA:
- Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.
- Pregnancy
- Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.
- Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Major Depressive Disorder
Individuals with Major Depressive Disorder |
|
Bipolar Disorder
Individuals with Bipolar Disorder |
|
Suicide Risk
Individuals at an elevated suicide risk |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Score on Montgomery Asberg Depression Rating Scale
Prazo: Weekly
|
Depression rating scale |
Weekly
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Score on Scale for Suicide Ideation
Prazo: Weekly
|
Scale for rating suicide ideation |
Weekly
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elizabeth D Ballard, Ph.D., National Institute of Mental Health (NIMH)
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
- 10001874
- 001874-M
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Clinical and research ratings, multi-modal MRI images, MEG scans, sleep studies, physiological, behavioral, and phenotypic data collected during the study, after deidentification.
Prazo de Compartilhamento de IPD
Starting within 1 year of completion of the study
Critérios de acesso de compartilhamento IPD
Participants data will only be shared if they have opted into the data share agreement. Data deposited into repositories will not be subject to any access, distribution, or reuse limitation beyond the standard procedures of the repository. Data will be uploaded to repositories listed in our NIH Intramural Research Program (IRP) Data Management and Sharing Plan. There are no restrictions on subsequent access, distribution, or reuse once the data is placed in a repository. The Branch Chief will review requests and access will need to be approved by the NIMH/DIRP SD and OCD NIMH and the NIH IRB.
Tipo de informação de suporte de compartilhamento de IPD
- SEIVA
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