Confirmatory Efficacy Clinical Trial of Amygdala Neurofeedback for Depression
杏仁核神经反馈治疗抑郁症的疗效临床试验
基本信息
- 批准号:10633760
- 负责人:
- 金额:$ 74.42万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-06-01 至 2028-05-31
- 项目状态:未结题
- 来源:
- 关键词:AdoptedAffectAlexithymiasAmygdaloid structureAnhedoniaAntidepressive AgentsAutobiographyBrainBrain regionClinicalClinical TrialsCommunitiesControl GroupsDataDiagnosisDiseaseDissemination and ImplementationDouble-Blind MethodEmotionalEnsureEvaluationFeedbackFunctional Magnetic Resonance ImagingGenderGoalsIndividualInterventionLiteratureMajor Depressive DisorderMeasuresMediatingMemoryMental DepressionOutcomeParticipantPatient Self-ReportPatientsPharmaceutical PreparationsPhaseProcessProviderProxyPublic HealthQuality of lifeRandomizedRecoveryRestSamplingScientistSeriesSignal TransductionSpecificityStimulusSymptomsTimeTrainingTranslational ResearchTreatment EfficacyWorkclinical effectclinically relevantconfirmatory clinical trialconfirmatory trialdepressive symptomsdesignefficacy evaluationexperimental groupfollow-upfuture implementationhemodynamicsimplementation determinantsimprovedindexingintervention refinementmemory recallneurofeedbacknovel therapeuticspharmacologicprocess evaluationpsychologicpublic health relevancerandomized, clinical trialsreduce symptomsresponsestakeholder perspectivessuccesssymptomatic improvementtreatment response
项目摘要
Abstract
Up to two-thirds of patients diagnosed with major depressive disorder (MDD) will not respond to standard
pharmacological and psychological interventions, suggesting a need to develop novel therapeutics. Decreased
reactivity to positive stimuli, indexed by low amygdala reactivity to positive autobiographical memory recall,
may be a causal mechanism interfering with recovery from MDD. Previous work suggests that individuals who
do respond to antidepressant medications show increased amygdala activity to positive stimuli that is
indistinguishable from controls, while those who do not respond fail to show this increase in amygdala activity.
In several small studies we have shown that MDD participants are able to increase their amygdala response
during positive memory recall via real-time fMRI neurofeedback (rtfMRI-nf) training, and that this increase is
associated with large and rapid reductions in depressive symptoms. Here, we propose to evaluate the efficacy
of this intervention in a large-scale confirmatory R01 clinical trial. N=200 MDD individuals will be randomly
assigned under double-blind conditions to the amygdala rtfMRI-nf intervention or to a control rtfMRI-nf
intervention where they receive yoked sham neurofeedback (instead of their own brain activity they see the
signal from another participant who underwent amygdala rtfMRI-nf). We propose to use the same
neurofeedback paradigm as our prior studies, with one critical difference. Rather than using a control condition
that involves training another brain region, we will adopt a yoked sham control group in order to demonstrate
that our findings are robust to the type of control condition used. We additionally aim to determine whether we
can use self-report mechanisms to assess who might need the proposed neurofeedback intervention and
whether they are likely to be successful in using it. Finally, we will work with implementation scientists to obtain
feedback from end-users and clinicians to understand contextual influences on outcomes and increase
intervention acceptability. Success will confirm a new non-pharmacological, non-invasive intervention for MDD
individuals.
摘要
项目成果
期刊论文数量(0)
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Kym Young其他文献
Kym Young的其他文献
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{{ truncateString('Kym Young', 18)}}的其他基金
Using fMRI of Autobiographical Memory Recall to Determine Risk and Resilience Endophenotypes in Familial Major Depressive Disorder
使用自传体记忆回忆的功能磁共振成像确定家族性重度抑郁症的风险和弹性内表型
- 批准号:
9912202 - 财政年份:2019
- 资助金额:
$ 74.42万 - 项目类别:
Using fMRI of Autobiographical Memory Recall to Determine Risk and Resilience Endophenotypes in Familial Major Depressive Disorder
使用自传体记忆回忆的功能磁共振成像确定家族性重度抑郁症的风险和弹性内表型
- 批准号:
10558686 - 财政年份:2019
- 资助金额:
$ 74.42万 - 项目类别:
Using fMRI of Autobiographical Memory Recall to Determine Risk and Resilience Endophenotypes in Familial Major Depressive Disorder
使用自传体记忆回忆的功能磁共振成像确定家族性重度抑郁症的风险和弹性内表型
- 批准号:
10335138 - 财政年份:2019
- 资助金额:
$ 74.42万 - 项目类别:
Amygdala rtfMRI Neurofeedback for Treatment Resistant Depression
杏仁核 rtfMRI 神经反馈治疗难治性抑郁症
- 批准号:
10634725 - 财政年份:2018
- 资助金额:
$ 74.42万 - 项目类别:
Amygdala rtfMRI Neurofeedback for Treatment Resistant Depression
杏仁核 rtfMRI 神经反馈治疗难治性抑郁症
- 批准号:
10611151 - 财政年份:2018
- 资助金额:
$ 74.42万 - 项目类别:
Effects of amygdala neurofeedback on depressive symptoms and processing biases
杏仁核神经反馈对抑郁症状和处理偏差的影响
- 批准号:
8698608 - 财政年份:2014
- 资助金额:
$ 74.42万 - 项目类别:
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