Major Depressive Disorder (MDD)Phase 2NCT07539805
Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression
A Phase 2 study testing Sertraline combined with Lactobacillus crispatus in people with Major Depressive Disorder (MDD) and Probiotic Intervention, run by First Affiliated Hospital of Chongqing Medical University at 2 sites in China.
Trial summary
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. 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 combined with Lactobacillus crispatus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 11 Jun 2026to Apr 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Affiliated Hospital of Chongqing Medical University
Chongqing, Yuzhong, 400010
Teng Teng, +18883368354, tengteng@hospital.cqmu.edu.cn
- Not yet recruiting
The Affiliated Dazu's Hospital of Chongqing Medical University
Longgang, Chongqing Municipality, 404100
About this study
Official title: Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial
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.
If there is a comparison group: Researchers will compare sertraline combined with Lactobacillus crispatus with sertraline combined with placebo ( look-alike substance that contains no probiotics) to determine whether the addition of Lactobacillus crispatus provides greater therapeutic benefit in adolescents with depression.
Participants will: 1. Receive sertraline combined with Lactobacillus crispatus or sertraline combined with placebo for 8 weeks; 2. Attend clinic visits every 4 weeks for clinical assessments and safety monitoring
- Being tested
- Sertraline combined with Lactobacillus crispatus, Sertraline combined with placebo
- 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.
Sertraline combined with Lactobacillus crispatusCombination product
Phase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day and titrated according to clinical judgment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will reach a minimum of 150 mg/day. Concomitantly, Lactobacillus crispatus powder will be administered at 1 sachet/day (1×10⁹ CFU/sachet).
Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical judgment. Lactobacillus crispatus powder will remain at 1 sachet/day (1×10⁹ CFU/sachet).
Sertraline combined with placeboCombination product
Phase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day based on the psychiatrist's clinical assessment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will attain at least 150 mg/day, with concomitant placebo powder at 1 sachet/day.
Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical assessment. Placebo powder will be maintained at 1 sachet/day.
| Study group | Role | What they receive |
|---|---|---|
| Sertraline combined with Lactobacillus crispatus group | Experimental | Not described Receives: Combination Product: Sertraline combined with Lactobacillus crispatus |
| Sertraline combined with placebo group | Active comparator | Not described Receives: Combination Product: Sertraline combined with placebo |
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 (14)
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
Change in the Screen for Child Anxiety-Related Emotional Disorders（SCARED）scores from baseline
The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scale will be administered to assess anxiety symptoms. Responses are made on a 3-point scale: 0 = "not true or hardly ever true", 1 = "somewhat true or sometimes true," and 2 = "very true or often true". Higher total scores indicate higher levels of anxiety.
Measured: Assessments will be performed at baseline, week 4, and week 8
Change in Hamilton Anxiety Scale (HAMA）scores from baseline
The Hamilton Anxiety Scale (HAMA) will be used to assess anxiety symptoms. Responses are made on a 5-point Likert scale (0 = Not present, to 4 = Very severe). Higher total scores indicate more severe anxiety symptoms.
Measured: Assessments will be performed at baseline, week 4, and week 8
Change in suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS ) scores from baseline
The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used assess the severity of suicidal ideation and suicidal behavior. It evaluates four core domains: suicidal ideation (5 items), intensity of ideation, (5-point scale), suicidal behaviors (actual, aborted, interrupted attempts, and preparatory acts), and lethality of suicide attempts. Higher scores indicate more severe suicidal ideation, and any suicidal behavior denotes elevated acute suicide risk.
Measured: Assessments will be performed at baseline, week 4, and week 8
Change in Young Mania Rating Scale (YMRS) scores from baseline
The Young Mania Rating Scale (YMRS) will be used to assess the severity of manic symptoms. It is a clinician-rated scale with 11 items. Total scores range from 0 to 60, with higher scores indicating more severe manic symptoms.
Measured: Assessments will be performed at baseline, week 4, and week 8
Changes in Ruminative Response Scale (RRS) scores from baseline
The Ruminative Response Scale (RRS) will be used to assess rumination. Responses are made on a 4-point Likert scale (1 = never to 4 = always), with total score ranges from 22 to 88. Higher scores indicate greater intensity of rumination.
Measured: Assessments will be performed at baseline, week 4, and week 8
Medication adherence
Medication adherence will be assessed by the pill count method. The adherence rate will be calculated according to the following formula:
Adherence rate= (Number of dispensed tablets-Number of returned unused tablets)/ (Daily prescribed tablets × Days between two visits) ×100% Adherence ≥ 80% was defined as adequate adherence.
Measured: Assessments will be performed at week 4, and week 8
Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline
The Connor-Davidson Resilience Scale (CD-RISC) is used to measure psychological resilience. Responses are made on a 5-point Likert scale (0 = never to 4 = always). The total score can range from 0 to 100, with higher scores indicating greater resilience.
Measured: Assessments will be performed at baseline, week 4, and week 8
Changes in Pediatric Quality of Life Inventory™ Version 4.0 Scale (PedsQL™) scores from baseline
The Pediatric Quality of Life Inventory 4.0 generic core scales (PedsQL4.0) is a self-rated scale for assessing pediatric health-related quality of life. Responses are made on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate better quality of life.
Measured: Assessments will be performed at baseline, week 4, and week 8
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline
The Pittsburgh Sleep Quality Index (PSQI) will be used for evaluating subjective sleep quality. Responses are made on a 4-point Likert scale, with total score ranges from 0 to 21. Higher scores indicate poorer overall sleep quality.
Measured: Assessments will be performed at baseline, Week 4, and Week 8
Changes in Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline
The Gastrointestinal Symptom Rating Scale (GSRS), a self-rated questionnaire, will be used to assess the severity of gastrointestinal symptoms. Responses are made on a 7-point Likert scale (1 = not at all to 7 = extremely severe). Higher scores indicate more severe gastrointestinal symptoms.
Measured: Changes from baseline to week 4 and week 8
Changes in Childhood Trauma Questionnaire (CTQ) scores from baseline
The Childhood Trauma Questionnaire (CTQ) will be used to assess childhood trauma. Responses were made on a 5-point Likert scale (1 = never to 5 = always). Higher scores indicate greater frequency and severity of child maltreatment experiences.
Measured: Assessments will be performed at baseline, week 4, and week 8
Changes in Clinical Global Impressions - Severity (CGI-S) scores from baseline
The Clinical Global Impressions-Severity (CGI-S), a clinician-rated outcome measure, was used to evaluate the overall severity of depressive symptoms. Higher CGI-S scores represent more severe overall illness.
Measured: Assessments will be performed at baseline, week 4, and week 8
Changes in Clinical global impressions-improvement (CGI-I) scores from baseline
The Clinical Global Impressions-Improvement (CGI-I) is an 8-point clinician-rated scale ranging from 0 to 7, which will be used to assess the overall improvement in depressive symptoms compared with baseline. Lower scores indicate greater clinical improvement.
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 posted20 Apr 2026
- Study start11 Jun 2026
- Primary completionFeb 2028 (estimated)
- Study completionApr 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
- 60 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
- NCT07539805
- Sponsor's protocol ID
- zz2025-535-03
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2026
- Last updated
- 15 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07539805
- Acronym / sponsor ID
- zz2025-535-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 20 Apr 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 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.
If there is a comparison group: Researchers will compare sertraline combined with Lactobacillus crispatus with sertraline combined with placebo ( look-alike substance that contains no probiotics) to determine whether the addition of Lactobacillus crispatus provides greater therapeutic benefit in adolescents with depression.
Participants will: 1. Receive sertraline combined with Lactobacillus crispatus or sertraline combined with placebo for 8 weeks; 2. Attend clinic 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 Lactobacillus crispatus group | Experimental | Combination Product: Sertraline combined with Lactobacillus crispatus |
| Sertraline combined with placebo group | Active comparator | Combination Product: Sertraline combined with placebo |
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
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Sertraline combined with Lactobacillus crispatusPhase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day and titrated according to clinical judgment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will reach a minimum of 150 mg/day. Concomitantly, Lactobacillus crispatus powder will be administered at 1 sachet/day (1×10⁹ CFU/sachet). Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical judgment. Lactobacillus crispatus powder will remain at 1 sachet/day (1×10⁹ CFU/sachet). | Combination product | Sertraline combined with Lactobacillus crispatus group |
| Sertraline combined with placeboPhase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day based on the psychiatrist's clinical assessment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will attain at least 150 mg/day, with concomitant placebo powder at 1 sachet/day. Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical assessment. Placebo powder will be maintained at 1 sachet/day. | Combination product | 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.
14 secondary outcomes
Change in Baker Depression Scale（BDI） scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in the Screen for Child Anxiety-Related Emotional Disorders（SCARED）scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in Hamilton Anxiety Scale (HAMA）scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS ) scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in Young Mania Rating Scale (YMRS) scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Changes in Ruminative Response Scale (RRS) scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Medication adherence
Time frame: Assessments will be performed at week 4, and week 8
Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Changes in Pediatric Quality of Life Inventory™ Version 4.0 Scale (PedsQL™) scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline
Time frame: Assessments will be performed at baseline, Week 4, and Week 8
Changes in Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline
Time frame: Changes from baseline to week 4 and week 8
Changes in Childhood Trauma Questionnaire (CTQ) scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Changes in Clinical Global Impressions - Severity (CGI-S) scores from baseline
Time frame: Assessments will be performed at baseline, week 4, and week 8
Changes in Clinical global impressions-improvement (CGI-I) 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 15 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.
2 sites 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 combined with Lactobacillus crispatus in people with Major Depressive Disorder (MDD) and Probiotic Intervention, run by First Affiliated Hospital of Chongqing Medical University at 2 sites 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 15 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 2 sites 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 15 Jun 2026.