Adolescent depression with childhood trauma
Conditions
Interventions
PBS-3001 group:On the basis of the original treatment, PBS-3001 (specification: 1mg per tablet) was combined for synergistic treatment, 0.5-2mg per day, taken once before bedtime
Placebo group:On the basis of the original treatment, a placebo (vitamin B1 tablets, 10mg per tablet) was combined for enhanced treatment, with a dose of 5-20mg per day, taken once before going to bed
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants and their guardians voluntarily participate in this clinical study and sign the informed consent form before starting any study operations; 2. Han nationality, male and female patients aged 9 years (including cut-offs) to under 24 years old, and weighing >=40kg; 3. Patients with depression with a current depressive episode duration of >=6 weeks at screening, meeting the diagnostic criteria for MDD in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), and confirming using the Brief International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid) for children; 4. Hamilton Depression Rating Scale (HAMD-24) score of >=18 points at screening and baseline; 5. Clinical Global Impressions Scale (CGI-S) score > 3 points at screening and baseline; 6. Childhood (before 17 years old) traumatic stress events; 7. Participant can understand and comply with the requirements of the study, as judged by the investigator.
Exclusion criteria
Exclusion criteria: 1. Schizoaffective psychosis, dysthymia, or bipolar depression; Those with any anxiety disorder as their primary diagnosis within 1 year; obsessive-compulsive disorder; Patients with substance abuse or dependence; personality disorders; 2. Various contraindications covered in the instructions for use of PBS-3001, such as: allergy to this product, hypotension (100bpm), large difference in blood pressure in the lying and standing position (? systolic blood pressure >20mmHg, ? diastolic blood pressure >10mmHg, or ? mean arterial pressure >20mmHg), or other patients who are not suitable for this treatment will not be included; 3. Patients with severe or unstable internal diseases such as heart, liver, kidney, endocrine organs, blood, and autoimmune diseases; Patients with epilepsy or other brain organic diseases; increased intracranial pressure, intractable and refractory hypertension, glaucoma, etc.; 4. History of severe suicide attempt, or current high risk of suicide, or HAMD item 3 suicide score >=3; 5. Previous use of NMDA receptor antagonists such as ketamine; 6. Receiving systematic antipsychotic treatment 2 weeks before enrollment; 7. Those who have received electroconvulsive therapy, rTMS therapy, or systematic psychotherapy in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale-24 items (HAMD-24); | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery–Asberg depression rating scale (MADRS);Columbia Suicide Severity Rating Scale (C-SSRS);Perceived Deficits Questionnaire–Depression (PDQ-D);Digit Symbol Substitution Test (DSST);Quality of Life (QoL);Sheehan Disability Scale (SDS); | — |
Countries
China
Contacts
Public ContactShikai Wang
Children‘s Hospital of Soochow University
Outcome results
None listed