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A randomized, controlled, blinded multicenter study on the effect evaluation of a gene guided precise treatment for antidepressants

A randomized, controlled, blinded multicenter study on the effect evaluation of a gene guided precise treatment for antidepressants

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079413
Enrollment
Unknown
Registered
2024-01-03
Start date
2024-01-15
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Major depressive disorder

Interventions

Pharmacogenetic guided treatment group:Pharmocogenetic testing
Treatment as usual:Treatment as ususal

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 55 Years

Inclusion criteria

Inclusion criteria: aged 8-55; Chinese Han population; Outpatient or inpatient patients; Diagnosed as depression by two or more psychiatrists, with a baseline Hamilton Depression Scale (HAMD-17) of = 18; Having a fixed residence, able to complete a 12 week acute phase treatment follow-up, and agreeing to cooperate with the researcher to complete the treatment follow-up on time; Understand the research content and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Suffering from serious physical diseases (such as metabolic diseases, kidney diseases, liver diseases, thyroid diseases, etc.) or organic brain diseases, can refer to laboratory abnormal indicators with a normal value of more than twice or combine with the opinion of the research doctor; A history of consciousness loss exceeding 5 minutes; Have a history of alcohol or substance abuse/dependence within the past year; Has undergone electroconvulsive therapy within the past six months; Regular use of addictive drugs within the past month; There are other mental disorders (personality disorders and mental retardation) that significantly affect the patient's current mental state; Those who currently have serious impulses, self harm, or attempted suicide; Pregnant or lactating women, or those planning to conceive; The researchers believe that there are situations that do not comply with the clinical study, or compliance cannot meet the follow-up requirements.

Design outcomes

Primary

MeasureTime frame
HAMD-17 total score reduction rate;cognitive valuation (MMSE);rate of adverse reaction;

Secondary

MeasureTime frame
effective rate ;remission rate;cognitive valuation (MOCA);

Countries

China

Contacts

Public ContactChunhua Zhou

The First Hospital of Hebei Medical University

zhouchunhua80@126.com+86 311 8715 6653

Outcome results

None listed

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