Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542640
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Mechanisms of Response to Therapeutic Intervention in Clinical High Risk CHR for Psychosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identifying Mechanisms of Response to Therapeutic Intervention in Clinical High Risk CHR for Psychosis a Bridge to Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study Psychobiological Follow-up Study of Transition from Prodrome to Early Psychosis will be conducted in collaboration with the Shanghai Mental Health Center SMHC and several data processing sites in the United States The current study builds on findings from the investigators previous work that identified several biomarkers in participants at clinical high risk CHR for psychosis that may be related to clinical outcomes such as the development of psychosis This study responds to the critical need to understand links between biomarkers could be clinical cognitive biological or other abnormalities and later clinical outcomes
Participants will receive either one of two real interventions or one of two sham a procedure that looks like the real treatment but is not interventions involving either 1 repetitive transcranial magnetic stimulation rTMS1 or 2 mindfulness-based real time fMRI neurofeedback mb-rt-fMRI-NFB Both procedures will measure brain capacity for change in CHR individuals thus paving the way forward for future therapeutic interventions
The main hypotheses to be addressed by this study are
1 - Following real interventions novel biomarkers will be more effective predictors of clinical outcome than standard biomarkers in participants at CHR for psychosis
2 - Following real interventions novel biomarkers will be more effective predictors of clinical outcomes in participants who received the real intervention than in participants who received sham treatments
3 - The novel interventions will reduce biomarker abnormalities in individuals with CHR relative to their own baselines and relative to healthy controls HC
4 - The sham interventions will will not reduce biomarker abnormalities in individuals with CHR relative to their own baselines or relative to HC
Participants will receive either one of two real interventions or one of two sham a procedure that looks like the real treatment but is not interventions involving either 1 repetitive transcranial magnetic stimulation rTMS1 or 2 mindfulness-based real time fMRI neurofeedback mb-rt-fMRI-NFB Both procedures will measure brain capacity for change in CHR individuals thus paving the way forward for future therapeutic interventions
The main hypotheses to be addressed by this study are
1 - Following real interventions novel biomarkers will be more effective predictors of clinical outcome than standard biomarkers in participants at CHR for psychosis
2 - Following real interventions novel biomarkers will be more effective predictors of clinical outcomes in participants who received the real intervention than in participants who received sham treatments
3 - The novel interventions will reduce biomarker abnormalities in individuals with CHR relative to their own baselines and relative to healthy controls HC
4 - The sham interventions will will not reduce biomarker abnormalities in individuals with CHR relative to their own baselines or relative to HC
Detailed Description:
This study builds upon our previous work entitled Psychobiological Follow-up Study of Transition from Prodrome to Early Psychosis R01MH111448 This study titled Mechanisms of Response to Therapeutic Intervention in Clinical High Risk CHR for Psychosis A bridge to treatment focuses on two persistent needs in clinical high risk CHR for psychosis research 1 the identification of novel biomarkers associated with transition to psychosis and other clinical outcomes and 2 the identification of symptom-specific brain circuit targets that can be engaged in future clinical trials The investigators hypothesize that clinically relevant biomarkers for participant-specific prognosis in CHR will be enhanced by the inclusion of biomarker measures that allow for the quantitative assessment of neural plasticity and are likely amenable to therapeutic change In this view CHR clinical outcomes are likely determined by both pathophysiology and by the brains capacity to adapt and respond to pathophysiology via neural plasticity mechanisms The investigators thus propose to examine brain circuit plasticity biomarkers relevant to CHR by administering non-invasive neuromodulation via two novel paradigms that as they demonstrated previously in schizophrenia engage brain networks involved in negative and positive psychiatric symptoms These two novel interventional techniques are 1 repetitive transcranial magnetic stimulation rTMS and 2 mindfulness-based real time functional magnetic resonance imaging rt-fMRI neurofeedback enhanced mindful meditation mb-rt-fMRI-NFB The investigators will also collect both traditional biomarkers for example clinical neuropsychological electrophysiological and neuroimaging biomarkers and the novel biomarkers listed above ie biomarkers that quantify neural changes pre- relative to post-intervention These two interventions which have not been used with CHR subjects before will be tested in 200 CHR 50 CHR per experimental condition and 100 HC over 5 years Furthermore the investigators will continue to enhance knowledge capacity at the Shanghai Mental Health Center SMHC where their Chinese collaborators are based They will also examine the effectiveness of these interventions in CHR as a bridge to future therapeutic treatments and will test traditional and novel biomarkers as predictors of clinical and neurocognitive outcomes Additionally the investigators will significantly enhance research capacity by building on already established achievements and collaborations and by extending their reach to new institutions Aim 4 This competitive renewal capitalizes on a unique set of strengths at a single site SMHC and on a collaboration with the Shanghai research team which has proven to be most productive in the current grant cycle The investigators hypothesize that this highly novel study will contribute to the development of future therapeutic interventions in CHR which will prevent this vulnerable population from developing adverse outcomes and at the same time will enrich the CHR field with new insights into the pathophysiology of this condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None