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

Somatic Symptom Clinical Trial

Official title:

Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression: a Prospective, Single-arm, Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05849272
• Other study ID #: SMHC-DSS-001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Shanghai Mental Health Center
• Contact: Zhen Wang, PhD,MD
• Phone: +86 34773516
• Email: wangzhen[@]smhc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Medically Unexplained Symptoms
• Somatic Symptom

Intervention

Drug:
• toludesvenlafaxine hydrochloride sustained-release tablets
orally once a day

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	8 Weeks
Primary	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).	8 Weeks
Secondary	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).	8 Weeks
Secondary	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.	8 Weeks
Secondary	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).	8 Weeks