Clinical impact of pharmacogenomic testing on schizophrenia and major depressive disorder: a randomized controlled trial

Development and implementation of personalized clinical decision support system in psychiatric disorders

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200059567

Enrollment

Unknown

Registered

2022-05-04

Start date

2022-05-01

Completion date

Unknown

Last updated

2024-03-18

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

Conditions

Schizophrenia and major depressive disorder

Interventions

Experimental group:Pharmacogenomic testing for drug management

Control group:Treatment as usual

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Schizophrenia: (1) Meet the diagnostic criteria for schizophrenia in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V); (2) Chinese Han nationality, aged 18-60 years; (3) Total score of Positive and Negative Symptom Scale (PANSS) >60, positive symptom factor score >=15 and/or negative symptom factor score >=15; (4) The patient (or guardian) gave informed consent to participate in this study. 2. Depression: (1) Meet DSM-V criteria and be diagnosed with depression; (2) Chinese Han nationality, aged 18-60 years; (3) Hamilton Depression Scale (HAM-D24) >20 points; (4) The patient (or guardian) gave informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Schizophrenia: (1) Patients who fail to respond to treatment with three or more antipsychotics (at least two of which differ in chemical structure); (2) Those who have taken antipsychotics within two weeks; (3) Use of mood stabilizers or antidepressants within a month; (4) Patients who had received modified electroconvulsive therapy (MECT) within one month; (5) A history of genetic diseases other than schizophrenia; (6) Currently suffering from serious physical diseases, severe impulsivity or suicide attempts. 2. Depression: (1) A diagnosis of bipolar disorder, schizophrenia or other psychotic disorders; (2) Those who have taken antidepressants or antipsychotics within two weeks; (3) Used a mood stabilizer within one month; (4) Those with a history of other genetic diseases; (5) Currently suffering from serious physical diseases, severe impulsivity or suicide attempts.

Design outcomes

Primary

Measure	Time frame
Positive and Negative Syndrome Scale;Hamilton Depression Scale;	—

Countries

China

Contacts

Public ContactQin Shengying

Shanghai Jiao Tong University

chinsir@sjtu.edu.cn+86 13916808925

Outcome results

None listed

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