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Study on the application of paroxetine treatment drug monitoring in the individualized medication regimen for the treatment of depression

Study on the application of paroxetine treatment drug monitoring in the individualized medication regimen for the treatment of depression

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061185
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Depressive disorder

Interventions

Normal dose group:Paroxetine therapeutic dose: 25mg qd
high dose group:Paroxetine therapeutic dose: 50mg qd
dose adjustment group:Paroxetine therapeutic dose: changed in treatment

Sponsors

Department of Pharmacy, ZhongDa Hospital, Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. During the treatment period, the subjects received TDM monitoring of paroxetine, and the medication compliance was good. After the first diagnosis, they were followed up on schedule; 2. It meets the diagnostic criteria of depression in DSM-V; 3. 17 items of Hamilton Depression Scale (HAMD-17) >= 17 points, and the first item (depression) score >= 2; 4. 18-80 years old, regardless of gender; 5. The patient agreed and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Accompanied by serious or unstable physical diseases, nervous system diseases and other mental disorders; 2. Patients used fluoxetine 3 weeks before enrollment, other antidepressants 1 week before enrollment, and more than 2 antidepressants at the same time after enrollment; 3. Women of childbearing age who are lactating, pregnant or do not take reasonable contraceptive measures; 4. Those who failed to take SSRI and SNRI drugs in the past, and those who were allergic to paroxetine in the past; 5. According to the judgment of the researcher, the medicine cannot be taken according to the doctor's advice.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale-17;

Secondary

MeasureTime frame
Hamilton Anxiety Scale-17;Plasma concentration of paroxetine;

Countries

China

Contacts

Public ContactLingjun Zhong

Department of Pharmacy, ZhongDa Hospital, Southeast University

zhonglingjun2017@163.com+86 13813882412

Outcome results

None listed

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