Major Depressive Disorder (MDD), Probiotic Intervention
Conditions
Brief summary
The objective of this clinical trial is to evaluate the efficacy and safety of sertraline combined with multi-strain probiotics in adolescents aged 12-18 with major depressive disorder. The primary research question is whether sertraline combined with multi-strain probiotics is superior to sertraline combined with placebo in alleviating depressive symptoms and improving mood symptoms in adolescents. If there is a control group: researchers will compare sertraline combined with multi-strain probiotics with sertraline combined with placebo (a substance that looks similar but does not contain probiotics) to determine whether adding multi-strain probiotics provides greater therapeutic benefits for adolescent patients with depression. Participants will: 1. Undergo 8 weeks of treatment with sertraline combined with multi-strain probiotics or sertraline combined with placebo; 2. Have clinical visits every 4 weeks for clinical assessments and safety monitoring.
Interventions
DRUGSertraline
Weeks 1-4, the starting dose of sertraline is 25 mg/day, adjusted according to the clinical assessment of the psychiatrist, with a dosage range of 25-150 mg/day. By week 4, the sertraline dosage should reach at least 150 mg/day; placebo powder, 1 sachet/day.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* • Aged 12-18 years * Meets DSM-5 criteria for major depressive disorder (MDD) and is currently in a depressive episode according to the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) interviews * Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline * Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline
Exclusion criteria
* • Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders * MDD with psychotic symptoms * Young Mania Rating Scale (YMRS) \>13 at baseline * History of neurological disorders (e.g., epilepsy, traumatic brain injury), or the presence of serious physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes mellitus, clinically significant pulmonary, hepatic, or renal impairment, or major trauma) * Nonresponse to at least two antidepressants with different mechanisms, and each administered at an adequate dose and for an adequate duration * History of intolerance to sertraline or nonresponse to an adequate therapeutic course of sertraline * Current high suicide risk * History of alcohol or drug abuse or dependence * Taking or administering antidepressants within 5 half-lives * Use of probiotic-related food or medicine within 2 weeks before enrollment * Systemic use of antibiotics or antifungals within 1 month before enrollment * History of severe food allergy or known hypersensitivity to the Lactobacillus crispatus preparation or any of its components * Adherence to vegetarian or other restrictive dietary patterns * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Children's Depression Rating Scale - Revised (CDRS-R) scores | Assessments will be performed at baseline, week 4, and week 8 | The Children's Depression Rating Scale-Revised (CDRS-R) is a semi-structured clinician-rated interview designed to assess the severity of depressive symptoms in children and adolescents. The total score ranges from 17 to 113, with higher scores indicating more severe depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baker Depression Scale#BDI# scores from baseline | Assessments will be performed at baseline, week 4, and week 8 | The Beck Depression Inventory (BDI) is a self-report inventory measuring the severity of depression. It consists of 21 items with 4 answer options each. The total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. |
Countries
China
Contacts
CONTACTTeng Teng
Outcome results
None listed