Skip to content

A study for the precision medicine for schizophrenia by integrating multi-omic profile

A study for the precision medicine for schizophrenia by integrating multi-omic profile

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018025
Enrollment
Unknown
Registered
2018-08-27
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-09-03

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

Conditions

Schizophrenia

Interventions

Group 1:Traditional medication
Group 2:Precision medication

Sponsors

Department of Mental Health Center, West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) First/recurrent hospitalized patients; 2) Meet clinical diagnostic criteria for schizophrenia, based on the assessment using the structured clinical interview (SCID) for DSM-IV-TR; 3) Currently between 18 to 45 years old; 4) The total score of the positive and negative symptom scale (PANSS) = 60 points (1-7 point version), of which at least 3 items having a score = 4 points; 5) Signed the written informed consent. If the patient is deemed incapacitated by illness, the written informed consent of the legal guardian is required.

Exclusion criteria

Exclusion criteria: 1) Meet the diagnostic criteria of DSM-IV for schizoaffective disorder, mood disorder, mental retardation (intellectual disability), generalized developmental disorder, delirium, dementia, memory impairment or other cognitive impairments; 2) Severe unstable physical illness; diagnosed diabetes, thyroid disease, hypertension, heart disease, etc.; 3) Angle-closure glaucoma; 4) History of epilepsy, not including that of febrile seizures; 5) Meet the diagnostic criteria of DSM-IV-TR for substance abuse (except for nicotine dependence); 6) Used long-acting antipsychotics in the previous treatment interval (minimal 5 weeks of wash-out period are required for RISPERDAL CONSTA); 7) Regular use of clozapine within one month prior to the enrollment; 8) Used ECT treatment one month before the enrollment; 9) History of Neuroleptic Malignant Syndrome (NMS) and severe tardive dyskinesia; 10) Currently have serious suicide attempts and agitation; 11) The presence of abnormal clinical laboratory findings (i.e. A serum AST/ALT level equal to or more than 5 to 10 times the upper limit of normal value; a BUN level equal to or more than 1.5 times the upper limit; a serum Cr level equal to or more than 1.2 times the upper limit); 12) Unable to follow the treatment plan and no available legal guardian; 13) ECG corrected-QTc interval = 450 milliseconds for male, = 470 milliseconds for female); 14) Current pregnancy or lactation, or recent plan for pregnancy; 15) Poor efficacy against three adequate trials of antipsychotics in the past (two of which have a different pharmacological mechanism; poor efficacy herein is defined as the presence of severe symptoms with poor social and work function); 16) The presence of contraindications for the antipsychotics used in this study.

Design outcomes

Primary

MeasureTime frame
Positive And Negative Syndrome Scale;Clinical Global Impression Scale;A Rating Scale for Extrapyramidal Side Effects;Barnes Akathisia Rating Scale;

Secondary

MeasureTime frame
blood pressure;height;weight;waist circumference;hip circumference;Triglycerides;cholesterol;high-density lipoprotein;low-density lipoprotein;fasting c-peptide;fasting insulin;fasting plasma glucose;2-hour postprandial plasma glucose;glycated hemoglobin;prolactin;

Countries

China

Contacts

Public ContactLi Tao

Department of Mental Health Center, West China Hospital of Sichuan University

xuntao26@hotmail.com+86 18980601817

Outcome results

None listed

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