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 range
18 Years – 65 Years
Sex
ALL
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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;
. 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;