NCT06580860

Brief Summary

This study focuses on the structure and function of the brain and gene expression in peripheral blood of patients with schizophrenia, to explore the interaction and influence between the three. Patients with mental disorders who have been recruited will take their medication regularly for 1 year and participate in baseline and follow-up assessments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,899

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Jan 2016Jan 2027

Study Start

First participant enrolled

January 1, 2016

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

11 years

First QC Date

August 28, 2024

Last Update Submit

March 11, 2026

Conditions

Keywords

schizophreniamajor depressive disorderautism spectrum disorderbipolar disordermagnetic resonance imagingmulti-omics

Outcome Measures

Primary Outcomes (3)

  • cortical morphology

    Data were obtained using magnetic resonance scans

    40 minutes

  • target gene charaacteristics

    10ml peripheral blood was extracted for gene analysis

    1 day

  • scale scores

    The score of each dimension and the total score were calculated according to the scale.The scale includes three dimensions: negative symptom, positive symptom and general psychopathology, and the score range of each dimension is different. The total score ranges from 30 to 210, with higher scores indicating worse results.

    90 minutes.

Study Arms (6)

PMNP-Healthy Norms

Healthy Norms

Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids

PMNP-Subclinical high-risk

Subclinical high-risk

Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids

PMNP-Schizophrenia and Psychosis

Schizophrenia and Psychosis patient

Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids

PMNP-MDD

major depressive disorder patient

Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids

PMNP-ASD

autism spectrum disorder patient

Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids

PMNP-BD

bipolar disorder patient

Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids

Interventions

Patients with mental disorders should take the appropriate medicine as prescribed by the doctor,and the health norms are not required to take medicine.This study will not interfere with the medication regimen of doctors.

PMNP-ASDPMNP-BDPMNP-Healthy NormsPMNP-MDDPMNP-Schizophrenia and PsychosisPMNP-Subclinical high-risk

Eligibility Criteria

Age13 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients from inpatient and outpatient the second Xiangya Hosptial of Central South University, Healthy controls from community, school and street recruitment

You may qualify if:

  • Age: 13-35 years old(Patients with healthy siblings can be extended to 14-35 years of age)
  • Course of disease: \<24 months
  • Priority is given to patients who have never taken medicine or duration of drug use \< 2 weeks
  • No nuclear magnetic contraindications.

You may not qualify if:

  • Family history of psychotic disorders, history of psychoactive substances abuse, alcohol dependence, or nicotine dependence
  • Have a major physical disease or infectious disease
  • History of coma and serious neurological disease 4.MRI contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Xiangya hospital of central south univerity

Changsha, Hunan, 410000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10ml peripheral blood

MeSH Terms

Conditions

Mental DisordersSchizophreniaDepressive Disorder, MajorAutism Spectrum DisorderBipolar Disorder

Interventions

Antipsychotic AgentsAntidepressive Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersDepressive DisorderMood DisordersChild Development Disorders, PervasiveNeurodevelopmental DisordersBipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing AgentsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesPsychotropic Drugs

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

January 1, 2016

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations