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A clinical study of the efficacy and multi-omics mechanism of divenlafaxine succinate sustained release tablets in the treatment of depression

A clinical study of the efficacy and multi-omics mechanism of divenlafaxine succinate sustained release tablets in the treatment of depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085409
Enrollment
Unknown
Registered
2024-06-06
Start date
2024-06-15
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Major depressive disorder

Interventions

Health group:None
Major Depressive disorder:Divenlafaxine sustained-release tablets

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for MDD patients: age range 8-65 years; Understand the research content and sign the informed consent; Meet the DSM-5 diagnostic criteria; Baseline score HAMD-17=18; Domicile fixed, able to complete 12 weeks of acute treatment follow-up, and agreed to cooperate with the investigator to complete treatment follow-up on time. Healthy subjects: age range 8-65 years old; Understand the research content and sign the informed consent; Does not meet the DSM-5 diagnostic criteria; Recruited by health examination center or advertisement.

Exclusion criteria

Exclusion criteria: Exclusion criteria for healthy and MDD patients: patients with serious physical diseases (such as metabolic diseases, kidney diseases, liver diseases, thyroid diseases, etc.) or organic brain diseases, can refer to the laboratory abnormal indicators more than 2 times the normal value or combined with the study doctor's opinion; A history of loss of consciousness for more than 5 minutes; A history of alcohol or substance abuse/dependence within the past 1 year; Electroconvulsive therapy in the past six months; Regular use of addictive drugs within the last month; The presence of other mental disorders (personality disorders and mental retardation) that significantly affect the subject's current mental state; Currently have serious impulse or self-injury, suicide attempt; Pregnant or lactating women, or those planning to become pregnant; The investigators concluded that there was a lack of compliance with the clinical study or that compliance did not meet follow-up requirements.

Design outcomes

Primary

MeasureTime frame
effective rate;remission rate;

Secondary

MeasureTime frame
HAMD-17 total score reduction rate;metabolome;proteome;Gut microbiome;

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