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Effekt og sikkerhed af Sertralin kombineret med Lactobacillus Crispatus hos unge med depression: Et multicenter randomiseret kontrolleret forsøg

11. juni 2026 opdateret af: Teng Teng, First Affiliated Hospital of Chongqing Medical University

Effekt og sikkerhed af Sertralin kombineret med Lactobacillus Crispatus hos unge med depression : Et multicenter randomiseret kontrolleret forsøg

Formålet med denne kliniske undersøgelse er at evaluere effektiviteten og sikkerheden af sertralin kombineret med Lactobacillus crispatus hos unge i alderen 12-18 år med alvorlig depressiv lidelse. Det primære spørgsmål, det sigter mod at besvare, er: Om sertralin kombineret med Lactobacillus crispatus er overlegen i forhold til sertralin kombineret med placebo i at reducere depressive symptomer og forbedre følelsesmæssige symptomer hos unge med depression.

Hvis der er en sammenligningsgruppe: Forskere vil sammenligne sertralin kombineret med Lactobacillus crispatus med sertralin kombineret med placebo (et lignende stof, der ikke indeholder probiotika) for at afgøre, om tilføjelsen af Lactobacillus crispatus giver større terapeutisk fordel hos unge med depression.

Deltagerne vil: 1. Modtage sertralin kombineret med Lactobacillus crispatus eller sertralin kombineret med placebo i 8 uger; 2. Deltage i klinikbesøg hver 4. uge til kliniske vurderinger og sikkerhedsovervågning

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Chongqing Municipality
      • Longgang, Chongqing Municipality, Kina, 404100
        • Ikke rekrutterer endnu
        • The Affiliated Dazu's Hospital of Chongqing Medical University
    • Yuzhong
      • Chongqing, Yuzhong, Kina, 400010
        • Rekruttering
        • The Affiliated Hospital of Chongqing Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier

  1. Alder 12-18 år;
  2. Opfylder DSM-5-kriterier for major depressiv lidelse (MDD) og er i en nuværende depressiv episode ifølge Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)-interviews;
  3. Child Depression Rating Scale-Revised (CDRS-R)-score ≥40 ved baseline;
  4. Clinical Global Impression Scale (CGI-S)-score ≥4 ved baseline. Eksklusionskriterier

1. Tilstedeværelse af enhver komorbid psykiatrisk lidelse ifølge DSM-5, bortset fra angstlidelser; 2. MDD med psykotiske symptomer; 3. Young Mania Rating Scale (YMRS) >13 ved baseline; 4. Tidligere neurologiske lidelser (f.eks. epilepsi, traumatisk hjerneskade) eller tilstedeværelse af alvorlige fysiske sygdomme (f.eks. thyreoideasygdom, lupus erythematosus, diabetes mellitus, klinisk signifikant lunge-, lever- eller nyreskade, eller større trauma); 5. Mangel på respons på mindst to antidepressiver med forskellige mekanismer, hvor hvert er administreret i en tilstrækkelig dosis og i en tilstrækkelig varighed; 6. Tidligere intolerance overfor sertralin eller mangel på respons på en tilstrækkelig terapeutisk behandling med sertralin; 7. Nuværende høj selvmordsrisiko; 8. Tidligere alkohol- eller stofmisbrug eller -afhængighed; 9. Indtagelse eller administration af antidepressiver inden for 5 halveringstider; 10. Brug af probiotisk-relateret mad eller medicin inden for 2 uger før inklusion; 11. Systemisk brug af antibiotika eller antimykotika inden for 1 måned før inklusion; 12. Tidligere svær fødevareallergi eller kendt overfølsomhed overfor Lactobacillus crispatus-præparatet eller nogen af dets komponenter; 13. Overholdelse af vegetarisk eller anden restriktiv kost; 14. Graviditet eller amning.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sertraline kombineret med Lactobacillus crispatus-gruppen
Kombinationsprodukt: Sertraline kombineret med Lactobacillus crispatus

Fase 1 (uge 1-4): Sertralin indledes med 25 mg/dag og titreres efter klinisk skøn med en tilladt dosis på 25-150 mg/dag. I uge 4 skal sertralindosis være mindst 150 mg/dag. Samtidig gives Lactobacillus crispatus-pulver i 1 pakke/dag (1×10⁹ CFU/pakke).

Fase 2 (uge 5-8): Sertralin opretholdes på 150-200 mg/dag med dosisjusteringer baseret på psykiaterens kliniske skøn. Lactobacillus crispatus-pulver fortsættes med 1 pakke/dag (1×10⁹ CFU/pakke).
Aktiv komparator: Sertralin kombineret med placebogruppe
Kombinationsprodukt: Sertralin kombineret med placebo

Fase 1 (uge 1-4): Sertralin vil blive indledt med 25 mg/dag baseret på psykiaterens kliniske vurdering, med en tilladt dosis på 25-150 mg/dag. Ved uge 4 vil sertralin-dosen nå mindst 150 mg/dag, med samtidig placebo-pulver på 1 pose/dag.

Fase 2 (uge 5-8): Sertralin vil blive vedligeholdt på 150-200 mg/dag, med dosisjusteringer vejledt af psykiaterens kliniske vurdering. Placebo-pulver vil blive vedligeholdt på 1 pose/dag.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Children's Depression Rating Scale - Revised (CDRS-R) scores
Tidsramme: 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.
Assessments will be performed at baseline, week 4, and week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Baker Depression Scale（BDI） scores from baseline
Tidsramme: 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.
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
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
Assessments will be performed at baseline, week 4, and week 8
Change in Hamilton Anxiety Scale (HAMA）scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
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
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
Assessments will be performed at baseline, week 4, and week 8
Change in Young Mania Rating Scale (YMRS) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
Assessments will be performed at baseline, week 4, and week 8
Changes in Ruminative Response Scale (RRS) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
Assessments will be performed at baseline, week 4, and week 8
Medication adherence
Tidsramme: Assessments will be performed at week 4, and week 8

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.
Assessments will be performed at week 4, and week 8
Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
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
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
Assessments will be performed at baseline, week 4, and week 8
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline
Tidsramme: Assessments will be performed at baseline, Week 4, and Week 8
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.
Assessments will be performed at baseline, Week 4, and Week 8
Changes in Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline
Tidsramme: Changes from baseline to week 4 and week 8
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.
Changes from baseline to week 4 and week 8
Changes in Childhood Trauma Questionnaire (CTQ) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
Assessments will be performed at baseline, week 4, and week 8
Changes in Clinical Global Impressions - Severity (CGI-S) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
Assessments will be performed at baseline, week 4, and week 8
Changes in Clinical global impressions-improvement (CGI-I) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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.
Assessments will be performed at baseline, week 4, and week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. juni 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

14. april 2026

Først indsendt, der opfyldte QC-kriterier

14. april 2026

Først opslået (Faktiske)

20. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • zz2025-535-03

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