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Study identifier: NCT06542640 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Mechanisms of Response to Therapeutic Intervention in Clinical High Risk (CHR) for Psychosis

Condition: Psychosis; Schizophrenia-Like · Healthy Controls  ·  Sponsor: Beth Israel Deaconess Medical Center

PhaseNA
Planned participants300
Who can joinAll sexes, 15 Years to 35 Years
Healthy volunteersYes

About this study

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 investigator's 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 (rTMS)1; 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 particip…

This description comes directly from the study's public registry record.

Talk to the study team

William S Stone, Ph.D.  ·  5087402050  ·  wstone@bidmc.harvard.edu

Margaret A Niznikiewicz, Ph.D.  ·  6176534627  ·  margaret_niznikiewicz@hms.harvard.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Shanghai Mental Health CenterShanghai, Shanghai Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06542640