Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorFirst Affiliated Hospital of Chongqing Medical University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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)
Trial design
Design model
Parallel
Treatments tested in this trial
Sertraline
DrugWeeks 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Sertraline combined with compound probiotics groupExperimental treatment 1 intervention
Group B: Sertraline combined with placebo groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessments will be performed at baseline, week 4, and week 8Secondary 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.
Time frame
Assessments will be performed at baseline, week 4, and week 8Other outcomes
1
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.
Time frame
Assessments will be performed at baseline, week 4, and week 82
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.
Time frame
Assessments will be performed at baseline, week 4, and week 83
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.
Time frame
Assessments will be performed at baseline, week 4, and week 84
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.
Time frame
Assessments will be performed at baseline, week 4, and week 8Sponsors and contacts
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Source ClinicalTrials.gov