Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression

Shanghai Mental Health Center

Status and phase: Completed; Phase 4

Conditions: Somatic Symptom

Treatments: Drug: toludesvenlafaxine hydrochloride sustained-release tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05849272

SMHC-DSS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Toludesvenlafaxine hydrochloride sustained-release tablets 80-160 mg group

Experimental group

Description:

orally once a day

Treatment:

Drug: toludesvenlafaxine hydrochloride sustained-release tablets