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Tests treatment safety and results for Major Depressive Disorder (MDD)
Official title Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression
ClinicalTrials.gov ID: NCT07539805
What this study is testing
What is Sertraline combined with Lactobacillus crispatus?
Sertraline combined with Lactobacillus crispatus is an investigational medicine, being studied as a potential treatment for major depressive disorder (mdd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the efficacy and safety of sertraline combined with Lactobacillus crispatus in adolescents aged 12-18 years with major depressive disorder. The main question it aims to answer is: Whether sertraline combined with Lactobacillus crispatus is superior to sertraline combined with placebo in reducing depressive symptoms and improving emotional symptoms in adolescents with depression.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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...
- Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline
- Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline
You likely can't join if
- 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...
- 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
See the full eligibility 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)...
- Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline
- Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Longgang, Chongqing Municipality, China
- Chongqing, Yuzhong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Longgang, Chongqing Municipality, China; Chongqing, Yuzhong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.