Major Depressive Disorder
Conditions
Interventions
Trial Group:Variable-Dose Monotherapy with Toludesvenlafaxine Hydrochloride Extended-Release Tablets
Sponsors
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
13 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with depressive disorder meeting the diagnostic criteria of DSM-5. 2. Aged 13–17 years old (including boundary values), regardless of gender. 3. CDI score >=20 points at screening. 4. YMRS score <7 points at screening. 5. No use of antidepressants or mood stabilizers within the past 2 weeks, no use of hypnotic drugs such as benzodiazepines within the past 3 days, and no use of fluoxetine or vortioxetine within the past 1 month. 6. The subject voluntarily participates in the trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with allergic constitution (allergic to two or more drugs or substances) or known allergy to the study drug or its formulation components. 2. Those with poor response or no response after at least 2 different mechanisms of action antidepressants administered at sufficient dosage and course in previous or current episodes. 3. Individuals with severe self-harm, obvious suicidal attempts or behaviors within the past 6 months, or those with a PANSI score >=36 at screening. 4. Those meeting the diagnostic criteria of other mental disorders, personality disorders, or intellectual developmental disorders in DSM-5, or with a history of substance dependence or drug abuse within the past 6 months. 5. Individuals with severe and unstable physical diseases or medical history, such as cardiovascular diseases, liver diseases, kidney diseases, blood diseases, endocrine diseases, etc. 6. Patients with poorly controlled hypertension (systolic blood pressure (SBP) >=140 mmHg or diastolic blood pressure (DBP) >=90 mmHg at screening). 7. Individuals with total bilirubin (TBIL) values >1.5 times the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal, creatinine (Cr) >1.2 times the upper limit of normal, or thyroid-stimulating hormone (TSH) outside the normal range at screening. 8. Individuals with circulatory system diseases such as torsades de pointes, short QT syndrome, long QT syndrome, second-degree or higher atrioventricular block, frequent ventricular premature beats, etc. at screening (e.g., resting heart rate 100 beats/min while awake, QTcF >450 ms in males, QTcF >470 ms in females, PR interval >0.20 s, etc.). 9. Individuals weighing less than 30 kg at screening. 10. Other conditions where the investigator deems the patient unsuitable for clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Children's Depression Inventory; | — |
Secondary
| Measure | Time frame |
|---|---|
| Screen for Child Anxiety Related Emotional Disorders;Temporal Experience of Pleasure Scale;Patient Health Questionnaire-15;Digital Symbol Substitution Test;Young Mania Rating Scale;Positive and Negative Suicide Ideation Scale;Conners' Parent Rating Scale;Childhood Trauma Questionnaire;Family Assessment Device;Clinical Global Impressions Scale;Quality of Life Scale for Children and Adolescents; | — |
Countries
China
Contacts
Public ContactWang Bin
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed