Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symp… (NCT05849272) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression
China60 participantsStarted 2023-05-12
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition (DSM-5) criteria for depression;
✓. Male or female aged ≥18 and ≤65 years;
✓. Subject has a Hamilton Depression Rating Scale (HAMD-17) total score \>17, anxiety/somatization factor ≥ 3;
✓. Subject has a total score of Patient Health Questionnaire-15 (PHQ-15) ≥5;
✓. Subject has a clear consciousness, no serious intellectual impairment, ability to speak autonomously, and no obvious symptoms of dementia;
✓. Subjects voluntarily participate in the study and sign the informed consent form
Exclusion criteria
✕. Allergic or known to be allergic to venlafaxine and desvenlafaxine;
✕. Subjects whose previous treatment with venlafaxine have failed, or whose previous treatment with at least 2 different types of antidepressants are ineffective;
✕. Subjects meet the diagnostic criteria for other psychotic disorders (except for depression) in DSM-5, personality disorders or intellectual disability, substance disorders or drug abuse within previous 6 months;
✕. Subjects meet the diagnostic criteria for clinically significant unstable diseases, such as hepatic insufficiency or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatic, immune, infectious, skin and subcutaneous tissue diseases or metabolic disorders;
What they're measuring
1
Patient Health Questionnaire-15 (PHQ-15)
Timeframe: 8 Weeks
2
The Chinese version of the Somatization Symptom Scale (SSS-CN)
. Subject has a severe self-injury/clear suicide attempt or behavior;
✕. With blood pressure \> 140/90 mmHg
✕. Total bilirubin (TBIL) values 1.5 times / alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal, or Thyroid-stimulating hormone (TSH) outside the normal range at screening;
✕. Electrocardiogram (ECG) abnormalities that are clinically significant at period of screening and that the investigator considers as inappropriate conditions for inclusion, such as QTc interval \> 470 ms in men and QTc interval \> 480 ms in female;