Major Depressive Disorder (MDD)Phase 2NCT07645157
Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression
A Phase 2 study testing Sertraline in people with Major Depressive Disorder (MDD) and Probiotic Intervention, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Probiotic Intervention
- What is being tested?
- Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Chongqing Medical University
Chongqing, Yuzhong, 400010
Teng Teng, +18883368354, tengteng@hospital.cqmu.edu.cn
About this study
Official title: A Study on the Efficacy and Safety of Sertraline Combined With Multi-Strain Probiotics in Treating Adolescent Patients With Depression: A Multi-Center Randomized Controlled Clinical Trial
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.
- Being tested
- Sertraline
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sertraline combined with compound probiotics group | Experimental | Phase 1: 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; compound probiotic powder, 1 sachet/day.
Phase 2: Weeks 5-8, the sertraline dosage is 150-200 mg/day, adjusted according to the clinical assessment of the psychiatrist; compound probiotic powder, 1 sachet/day. Receives: Drug: Sertraline |
| Sertraline combined with placebo group | Experimental | Phase 1: 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.
Phase 2: Weeks 5-8, the sertraline dosage is 150-200 mg/day, adjusted according to the clinical assessment of the psychiatrist; placebo powder, 1 sachet/day. Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children's Depression Rating Scale - Revised (CDRS-R) scores
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.
Measured: Assessments will be performed at baseline, week 4, and week 8
Secondary outcomes (1)
Change in Baker Depression Scale#BDI# scores from baseline
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.
Measured: Assessments will be performed at baseline, week 4, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teng Teng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645157
- Sponsor's protocol ID
- ZZ2025-940-02
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Sertraline Combined With Multi-Strain Probiotics in Treating Adolescent Patients With Depression: A Multi-Center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07645157
- Acronym / sponsor ID
- ZZ2025-940-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertraline combined with compound probiotics group | Experimental | Drug: SertralinePhase 1: 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; compound probiotic powder, 1 sachet/day. Phase 2: Weeks 5-8, the sertraline dosage is 150-200 mg/day, adjusted according to the clinical assessment of the psychiatrist; compound probiotic powder, 1 sachet/day. |
| Sertraline combined with placebo group | Experimental | Drug: SertralinePhase 1: 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. Phase 2: Weeks 5-8, the sertraline dosage is 150-200 mg/day, adjusted according to the clinical assessment of the psychiatrist; placebo powder, 1 sachet/day. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- • Aged 12-18 years
Key exclusion criteria (14 listed)
- • Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineWeeks 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. | Drug | Sertraline combined with compound probiotics group, Sertraline combined with placebo group |
Primary outcome
Change in Children's Depression Rating Scale - Revised (CDRS-R) scores
Time frame: 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.
1 secondary outcome
Change in Baker Depression Scale#BDI# scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sertraline in people with Major Depressive Disorder (MDD) and Probiotic Intervention, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teng Teng (+86 18883368354, tengteng@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Children's Depression Rating Scale - Revised (CDRS-R) scores (time frame: Assessments will be performed at baseline, week 4, and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.