Clinical trial NCT05849272: Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression
Official title: Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression: a Prospective, Single-arm, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Somatic Symptom
Keywords: medical treatment
somatic symptom
depression
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition (DSM-5) criteria for depression;
2. Male or female aged ≥18 and ≤65 years;
3. Subject has a Hamilton Depression Rating Scale (HAMD-17) total score \>17, anxiety/somatization factor ≥ 3;
4. Subject has a total score of Patient Health Questionnaire-15 (PHQ-15) ≥5;
5. Subject has a clear consciousness, no serious intellectual impairment, ability to speak autonomously, and no obvious symptoms of dementia;
6. Subjects voluntarily participate in the study and sign the informed consent form

Exclusion Criteria:

1. Allergic or known to be allergic to venlafaxine and desvenlafaxine;
2. Subjects whose previous treatment with venlafaxine have failed, or whose previous treatment with at least 2 different types of antidepressants are ineffective;
3. 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;
4. 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;
5. Subject has a severe self-injury/clear suicide attempt or behavior;
6. With blood pressure \> 140/90 mmHg
7. 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;
8. 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;
9. Subject has a history of moderate or severe brain trauma (for example, loss of consciousness ≥1 hour) or other neurological disorders or systemic diseases, which may affect the neurological function of CNS;
10. Pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period;
11. Other conditions that the investigator considers the participant is not suitable for the study

Primary outcomes:
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: 8 Weeks
measure: The Chinese version of the Somatization Symptom Scale (SSS-CN)
timeFrame: 8 Weeks
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 8 Weeks
measure: Multidimensional Fatigue Index (MFI-20)
timeFrame: 8 Weeks
measure: Sheehan Disability Scale (SDS)
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References: