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The establishment of objective diagnostic indicators and individualized drug treatment in early-onset schizophrenia (EOS)

The establishment of objective diagnostic indicators and individualized drug treatment in early-onset schizophrenia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025838
Enrollment
Unknown
Registered
2019-09-10
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early-onset schizophrenia

Interventions

Gold Standard:Diagnositc criteria for schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM5).
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Sponsors

The First Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 16 Years

Inclusion criteria

Inclusion criteria: The patient group: 1. Patients and their families/guardian agree to participate in this study and signed informed consent; 2. coming from the Han nationality; 3. aged between 7 and 16 years; 4. in the first episode and drug-naive, or with a washout period of at least 1 month; 5. meeting the diagnositc criteria for schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM5); 6. being diagnosed by two attending psychiatrists or senior psychiatrists independently with consistent diagonosis; 7. with a total score of the Positive and negative symptoms scale (PANSS)>= 60. The control group: 1. agreeing to participate in this study and signed informed consent; 2. coming from the Han nationality; 3. aged between 7 and 16 years; 4. meeting none of the diagnositc criterion in DSM5; 5. having no family history of psychiatric disorders or inherited neurologic diseases; 6. matches with the patient group according to age, sex and education.

Exclusion criteria

Exclusion criteria: The patient group: 1. Having a history of head injury and major body disease or other neural and psychiatric disorders; 2. having received modified electric convulsive therapy(MECT), antipsychotic treatment or antidepressant treatment in a month; 3. with a history of drug-induced neuroleptic malignant syndrome or severe tardive dyskinesia; 4. with severe suicide attempt or serious agitation; 5. with obvious abnormal laboratory results (AST or ALT of upper limit of normal or 2 times; BUN of upper limit of normal or 1.5 times;Cr of upper limit of normal or 1.2 times); QTc duration extended(male QTc >= 450ms or female QTc >= 470ms); 6. cannot be prescribed medication or guardian; 7. pregnant or breasting-feeding women,or planning a pregnancy; 8. resistent to two antipsychotics with different mechanisms; 9. having contraindications for the drugs recommended; 10. having contraindications for magnetic resonance imaging (MRI)scanning (such as pregnant women, patients with cardiac pacemakers, patients with aneurysm clip after craniocerebral surgery , patients with ferromagnetic implants, patients with artficial metal valve after heart surger,with metal prosthesis, metal joint, insulin pump or never stimulator in the body,etc); 11. having participated in other clinical trials in recent 30 days. The control group: 1.Having a history of brain organic diseases or other major body disease, neural and psychiatric disorders; 2. having a history of head injury and loss of consciousness for more than 30 minutes; 3. having a history of alcohol or drug abuse; 4. with obvious abnormal laboratory results (with the value more than 1.5 times of the upper limit of reference value range); 5. pregnant or breasting-feeding women; 6. having contraindications for magnetic resonance imaging (MRI)scanning; 7. having participated in other clinical trials in recent 30 days.

Design outcomes

Primary

MeasureTime frame
DNA, mRNA, miRNA of peripheral blood;brain images from magnetic resonance imaging (MRI) scanning;measurements of clinical symptoms;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
measurements of cognitive functions;measuments of psychosocial informantion;

Countries

China

Contacts

Public ContactXu Yong

The First Hospital of Shanxi Medical University

xuyongsmu@vip.163.com+86 18234016125

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026