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A Randomized Controlled Trial of Desvenlafaxine versus Venlafaxine in the Treatment of SSRI-Resistant Depression

A Randomized Controlled Trial of Desvenlafaxine versus Venlafaxine in the Treatment of SSRI-Resistant Depression

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116575
Enrollment
Unknown
Registered
2026-01-12
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Major Depressive Disorder

Interventions

The control group:Received venlafaxine extended-release capsules
The experimental group:Received desvenlafaxine succinate extended-release tablets

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.All participants were between 18 and 65 years of age; 2.All participants provided written informed consent; 3.All patients were diagnosed with depressive disorder or recurrent depressive disorder by at least two attending psychiatrists with the rank of associate chief physician or higher, according to the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) criteria; 4.Who showed treatment resistance to one prior SSRI trial (adequate dose and duration of >=4 weeks), with a MADRS score remaining >=20; 5.Participants were required to have a minimum of 9 years of formal schooling to ensure adequate comprehension of study procedures and rating scales.

Exclusion criteria

Exclusion criteria: 1.Patients were excluded if they had any of the following: (1) a comorbid severe psychiatric disorder (e.g., bipolar disorder or schizophrenia); (2) cognitive or speech impairment; or (3) a history of alcohol or drug abuse within the past 6 months; 2.Exclusion criteria also covered major somatic illnesses, including uncontrolled cardiovascular, hepatic, renal, or neurological diseases, glaucoma, active thyroid disorders, cancer, and benign prostatic hyperplasia; 3.Known hypersensitivity to the study drugs; 4.Inability or unwillingness to comply with the study protocol; 5.Pregnancy, lactation, or women of childbearing potential not using effective contraception; 6.Active suicidal ideation/behavior or depressive episodes with severe psychotic features.

Design outcomes

Primary

MeasureTime frame
Change from baseline in the Montgomery-?sberg Depression Rating Scale (MADRS) total score.;17-item Hamilton Depression Rating Scale (HAMD-17),;

Secondary

MeasureTime frame
The Hamilton Anxiety Rating Scale (HAMA), the Snaith-Hamilton Pleasure Scale (SHAPS), and the 36-Item Short Form Health Survey (SF-36);Change scores from baseline on the Treatment Emergent Symptom Scale (TESS).;Electrocardiogram (ECG);Laboratory tests, including complete blood count (CBC), urinalysis, blood biochemistry, human chorionic gonadotropin (hCG), and thyroid function tests (TFTs).;THINC-integrated tool;

Countries

China

Contacts

Public ContactGuanglei Xun

Shandong Mental Health Center

xungl@163.com+86 531 86336756

Outcome results

None listed

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