The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of somatic symptoms in depression, to provide evidence-based basis for clinical rational drug use.
The study included 60 patients (aged 18 to 65 years) who meet the diagnostic criteria for depression in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and who are accompanied by physical symptoms. All enrolled subjects were given toludesvenlafaxine hydrochloride sustained-release tablets monotherapy for 8 weeks, followed up at period of enrollment as baseline and at the end of 2th, 4th and 8th weeks. Adverse events were recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
orally once a day
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Patient Health Questionnaire-15 (PHQ-15)
The PHQ-15 has a 15-item checklist. Items are rated on a scale of 0-2, for a total score range of 0 -30 (scores ≥ 5, ≥10, ≥15 represent mild, moderate and severe levels of somatization).
Time frame: 8 Weeks
The Chinese version of the Somatization Symptom Scale (SSS-CN)
The SSS-CN has a 20-item checklist. Items are rated on a scale of 1-4, for a total score range of 20-80 (scores between 20-29, 30-39, 40-59, ≥60 correspond normal, mild, moderate and severe levels of somatic symptom disorder).
Time frame: 8 Weeks
Visual Analog Scale (VAS)
The VAS is a validated, subjective measure for acute and chronic pain. The total score range of 0 -10 (from no pain to worst pain).
Time frame: 8 Weeks
Multidimensional Fatigue Index (MFI-20)
The MFI-20 has a 20-item checklist, consist of 5 subscales. Items are rated on a scale of 1-5, for a total score range of 20 -100 (high scores represent more fatigue) and each subscale range of 4-20.
Time frame: 8 Weeks
Sheehan Disability Scale (SDS)
The SDS has a 5-item checklist. The total scores range of 0 -30 (from no impairment to highly impairment of function of normal life).
Time frame: 8 Weeks
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