- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02655978
Rostral Dorsal Cingulum Bundle Connectivity in Patients With Bipolar Disorder
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion and Exclusion Criteria for Group 1: Healthy Volunteers
a. Inclusion Criteria for Group 1:
i. Male or female, age 18 or older
ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements
iii. In the opinion of the investigator, has the competency to understand and sign the informed consent
iv. Physically healthy
v. Without any current and/or lifetime psychiatric disorder assessed with a Structured Clinical Interview for psychiatric Disorders, including the Mini International Neuropsychiatric Interview (MINI)
b. Exclusion Criteria for Group 1:
i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
ii. Progressive neurological disease such as neurodegenerative disease
iii. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)
iv. Any psychiatric disorder including any severe personality disorder
v. Currently pregnant or planning to become pregnant
vi. Any other contraindications to the brain imaging procedures.
vii. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
viii. Currently taking any steroids, stimulants, or opioid pain killers.
ix. Currently experiencing nicotine dependence or any smoking of cigarettes or use of other nicotine containing products within a week before the imaging visit.
Inclusion and Exclusion Criteria for Group 2: Medically Treatment-Responsive Bipolar Disorder
a. Inclusion Criteria for Group 2:
i. Male or female, age 18 or older
ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements
iii. In the opinion of the investigator, has the competency to understand and sign the informed consent
iv. Meets diagnostic criteria for BDI or BDII according to the DSM-V criteria, as confirmed by a systematic clinical interview and the administration of the MINI
v. A recent episode of depression, currently in remission with evidence-based treatments for bipolar disorder
vi. Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤ 10
vii. Young Mania Rating Scale (YMRS, Young et al 1988) total score ≤ 8
viii. Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≤ 2
ix. Subject is compliant with taking medication per the investigator's discretion
b. Exclusion Criteria for Group 2:
i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
ii. Progressive neurological disease such as neurodegenerative disease
iii. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)
iv. Contribution of any co-occurring psychiatric comorbidity that is disproportionate to the contribution of BDI or BDII, such as severe obsessive-compulsive disorder (OCD) or post-traumatic stress disorder (PTSD)
v. Meets criteria for antisocial personality disorder
vi. Meets criteria for having borderline personality disorder
vii. There will be no exclusions based on prescribed CNS-active medications
viii. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
ix. Meets DSM-V criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine and/or nicotine
x. Currently pregnant or planning to become pregnant
xi. Any other contraindications to the brain imaging procedures.
Inclusion and Exclusion Criteria for Group 3: Treatment-Refractory Bipolar Disorder
a. Inclusion Criteria for Group 3:
i. Male or female, age 18 or older
ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements
iii. In the opinion of the investigator, has the competency to understand and sign the informed consent
iv. Meets diagnostic criteria for BDI or BDII, currently depressed, at least moderately severe with or without psychotic features, according to the DSM-V criteria, as confirmed by a systematic clinical interview and the administration of the Structured Clinical Interview for Psychiatric Disorders, including the Mini International Neuropsychiatric Interview (MINI)
v. Current episode lasting at least 6 months and not responding to 2 adequate evidence-based treatments for BDI or BDII assessed with the assistance of Modified Antidepressant Treatment History Form (MATHF) and verified through medical records if possible
vi. If a subject has refused treatment with a particular FDA-approved mood stabilizer due to reasons of unacceptable side effects (such as weight gain, etc.), their wishes will be respected
vii. Depression severity should be measured with Montgomery-Asberg Depression Rating Scale (MADRS). A MADRS total score ≥ 20 is required at Screening Visit/Baseline Evaluation.
viii. Has experienced marked impairment as documented by a score consistent with severe impairment (7 or more on at least one of the three subscales of the Sheehan Disability Scale (SDS), which includes an assessment of work-life, family-life, and social life (no/mild impairment 0-3, moderate impairment 4-6, severe impairment 7-10)
ix. Bipolar disorder and current depressive episode as the primary source of the patient's disability, according to both the subject and the psychiatrist
b. Exclusion Criteria for Group 3:
i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)
ii. Progressive neurological disease such as neurodegenerative disease
iii. Preexisting implanted electrical device (such as pacemaker or cardiac defibrillator)
iv. Contribution of any co-occurring psychiatric comorbidity that disproportionate to the contribution of BDI or BDII, such as severe obsessive-compulsive disorder (OCD) or post-traumatic stress disorder (PTSD)
v. Meets criteria for antisocial personality disorder
vi. Meets criteria for having borderline personality disorder
vii. There will be no exclusions based on prescribed CNS-active medications
viii. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription
ix. Meets DSM-V criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine and/or nicotine
x. Active suicidal ideation with a plan or intent, a suicide attempt within past 6 months or more than 2 suicide attempts within the past 2 years
xi. Currently pregnant or planning to become pregnant
xii. Any other contraindications to the brain imaging procedures.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Healthy Volunteers
These participants will not have any psychiatric disorder as assessed by a structured clinical interview for psychiatric disorders.
|
|
Medically Treatment-Responsive BD
This group will be composed of participants who have BDI or BDII and have most recently been depressed but are currently in remission with evidence-based treatments for bipolar disorder
|
|
Treatment-Refractory BD
This group will be composed of participants who have BDI or BDII, are currently depressed with their current episode lasting at least 12 months and not responding to 4 adequate evidence-based treatments for BDI or BDII and who have failed, been intolerant to, or were unwilling to try electroconvulsive therapy (ECT).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Differences in connectivity in the rostral dorsal CB in patients with BDI or or BDII compared to matched controls
Prazo: Day 1
|
The imaging visit will consist of an MRI with diffusion-weighted imaging (DWI) sequences
|
Day 1
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer A Sweet, MD, University Hospitals Cleveland Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 02-15-35
- KL2TR000440 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .
Ensaios clínicos em Transtorno bipolar
-
ProgenaBiomeRecrutamentoTranstorno bipolar | Transtorno Bipolar I | Transtorno Bipolar II | Transtorno Bipolar Tipo I | Transtorno Bipolar Leve | Transtorno Bipolar Moderado | Transtorno Bipolar GraveEstados Unidos
-
Region StockholmKarolinska InstitutetRecrutamentoTranstorno bipolar | Depressão bipolar | Transtorno Bipolar I | Transtorno Bipolar II | Transtorno Afetivo Bipolar; Remissão em | Transtorno Afetivo Bipolar, Atualmente Deprimido, ModeradoSuécia
-
University of PittsburghNational Alliance for Research on Schizophrenia and DepressionConcluídoTranstorno Bipolar I | Transtorno Bipolar II | Transtorno Bipolar SOEEstados Unidos
-
Joshua RosenblatRecrutamentoTranstorno bipolar | Depressão bipolar | Transtorno Bipolar I | Transtorno Bipolar IICanadá
-
National Human Genome Research Institute (NHGRI)ConcluídoTranstorno Bipolar (DB) | BipolarEstados Unidos
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do Sul; Hospital Moinhos de VentoAtivo, não recrutandoTranstorno bipolar | Depressão bipolar | Transtorno Depressivo Maior | Transtorno Bipolar I | Transtorno afetivo | Transtorno Bipolar IIBrasil
-
Medical University of South CarolinaMilken InstituteConcluídoTranstorno bipolar | Transtorno Bipolar I | Transtorno Bipolar IIEstados Unidos
-
Mehmet Diyaddin GülekenConcluídoTranstorno Bipolar I, Episódio Deprimido Mais Recente
-
Joshua RosenblatRecrutamentoTranstorno bipolar | Depressão bipolar | Transtorno Bipolar I | Transtorno Bipolar IICanadá
-
Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationConcluídoTranstorno bipolar | Depressão bipolar | Transtorno Bipolar I | Transtorno Bipolar I | Transtorno Afetivo BipolarEstados Unidos
Ensaios clínicos em Imagem de ressonância magnética
-
Francisco SelvaConcluído
-
Francisco SelvaRetirado
-
Francisco SelvaRetirado
-
Paolo PesceConcluídoRebordo Alveolar EdêntuloItália
-
Medical Centre LeeuwardenUniversity of Groningen; LIMIS DevelopmentRecrutamentoCâncer PulmonarHolanda
-
Erasmus Medical CenterConcluído
-
Medical Centre LeeuwardenUniversity of Groningen; LIMIS DevelopmentRecrutamento
-
University of Texas Southwestern Medical CenterRecrutamentoÚlcera do pé diabéticoEstados Unidos
-
Dartmouth-Hitchcock Medical CenterDartmouth CollegeConcluído
-
Sohag UniversityAinda não está recrutandoAberração, frente de onda da córnea