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Randomized controlled trial on the efficacy and safety of individualized gene-guided treatment of schizophrenia and major depressive disorder

Randomized controlled trial on the efficacy and safety of individualized gene-guided treatment of schizophrenia and major depressive disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029671
Enrollment
Unknown
Registered
2020-02-09
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-02-17

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:Gene-guided treatment
control group:Treatment as usual

Sponsors

Institute of Mental Health of Beijing University's Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for patients with schizophrenia: (1) Each patient should be diagnosed as schizophrenia according to the DSM-IV criteria; (2) Aged 18 to 60 years; (3) Both the patients and their parents are Chinese Han descents; (4) The total scores of the PANSS are more than 60(each item is scored from 1 to 7); (5) The patient can complete the 12-week follow-up, and agreed to cooperate with the researcher to complete the treatment follow-up on time; (6) All of the patients or their guardians should give the written informed consent. 2. Inclusion criteria for patients with major depressive disorder (1) Aged 18-60 years; (2) Both the patients and their parents are Chinese Han descents; (3) Outpatient or inpatient; (4) Depression was clearly diagnosed by 2 attending psychiatrists and above; (5) The baseline Hamilton depression scale (HAMD) was >= 18; (6) The patient can complete the 12-week follow-up, and agreed to cooperate with the researcher to complete the treatment follow-up on time; (7) All of the patients or their guardians should give the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for patients with schizophrenia: (1) Patients with pregnancy or breast-feeding; (2) Patients with more than 5 minutes of loss of consciousness; (3) Patients with severe or unstable physical diseases; (4) Patients who have received electroconvulsive therapy in the past six months (5) Patients that regular use addictive drugs for nearly one month; (6) Patients with other mental disorders according to DSM-IV criteria. 2. Exclusion criteria for patients with major depressive disorder (1) Patients with pregnancy or breast-feeding; (2) Patients with more than 5 minutes of loss of consciousness; (3) Patients with severe or unstable physical diseases; (4) Patients who have received electroconvulsive therapy in the past six months (5) Patients that regular use addictive drugs for nearly one month; (6) Patients with other mental disorders according to the DSM-IV criteria.

Design outcomes

Primary

MeasureTime frame
PANSS;Hamilton Depression Scale;

Countries

China

Contacts

Public ContactYue Weihua

Institute of Mental Health of Beijing University's Sixth Hospital

dryue@bjmu.edu.cn+86 10 82805307

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026