Actively Recruiting

Phase Not Applicable
Age: 15Years - 35Years
All Genders
Healthy Volunteers
NCT06542640

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

Led by Beth Israel Deaconess Medical Center · Updated on 2025-04-20

300

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

S

Shanghai Jiao Tong University School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 15Years - 35Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female between 15 and 35 years old
  • Able to understand and sign informed consent or assent
  • No alcohol or drug dependence in the past 3 months
  • No use of substances on the day of assessment and not intoxicated or hung-over
  • Meet diagnostic criteria for prodromal syndrome or Schizotypal Personality Disorder if under 19
  • May be remitted from CHR syndrome or converted to full psychotic disorder but still eligible for follow-up
  • Healthy controls must meet inclusion criteria 1-2, no prodromal or psychotic disorders, no Cluster A personality disorder, and no current psychotropic medication
  • Healthy controls must have no family history of schizophrenia, schizoaffective disorder, schizotypal personality disorder, or psychotic disorders in first-degree relatives
Not Eligible

You will not qualify if you...

  • Current or lifetime Axis I psychotic disorder at baseline
  • Intellectual functioning with IQ less than 70
  • Past or current significant central nervous system disorder affecting prodromal symptoms
  • Traumatic brain injury rated 7 or above or current concussion interfering with assessments
  • Prodromal symptoms clearly caused by other psychiatric disorders like substance use disorders
  • Healthy controls excluded if they have any prodromal syndrome, psychotic disorder, Cluster A personality disorder, or are on psychotropic medications at baseline

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

W

William S Stone, Ph.D.

CONTACT

M

Margaret A Niznikiewicz, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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