Effekt og sikkerhet av sertralin kombinert med Lactobacillus crispatus hos ungdom med depresjon : En multikenter randomisert kontrollert studie
Effekt og sikkerhet ved sertralin kombinert med Lactobacillus crispatus hos ungdom med depresjon: En multikenter randomisert kontrollert studie
Målet med denne kliniske studien er å evaluere effektiviteten og sikkerheten til sertralin kombinert med Lactobacillus crispatus hos ungdom i alderen 12–18 år med major depresjonslidelse. Hovedspørsmålet den tar sikte på å besvare er: Om sertralin kombinert med Lactobacillus crispatus er overlegen sertralin kombinert med placebo i å redusere depressive symptomer og forbedre emosjonelle symptomer hos ungdom med depresjon.
Hvis det er en sammenligningsgruppe: Forskere vil sammenligne sertralin kombinert med Lactobacillus crispatus med sertralin kombinert med placebo (et lignende stoff som ikke inneholder probiotika) for å avgjøre om tillegg av Lactobacillus crispatus gir større terapeutisk fordel hos ungdom med depresjon.
Deltakere vil: 1. Motta sertralin kombinert med Lactobacillus crispatus eller sertralin kombinert med placebo i 8 uker; 2. Delta på klinikkbesøk hver 4. uke for kliniske vurderinger og sikkerhetsovervåkning
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Teng Teng
- Telefonnummer: +86 18883368354
- E-post: tengteng@hospital.cqmu.edu.cn
Studiesteder
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Chongqing Municipality
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Longgang, Chongqing Municipality, Kina, 404100
- Har ikke rekruttert ennå
- The Affiliated Dazu's Hospital of Chongqing Medical University
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Yuzhong
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Chongqing, Yuzhong, Kina, 400010
- Rekruttering
- The Affiliated Hospital of Chongqing Medical University
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Ta kontakt med:
- Teng Teng
- Telefonnummer: +18883368354
- E-post: tengteng@hospital.cqmu.edu.cn
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier
- Alder 12-18 år;
- Oppfyller DSM-5-kriterier for major depressiv lidelse (MDD) og er for tiden i en depressiv episode ifølge Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)-intervjuer;
- Child Depression Rating Scale-Revised (CDRS-R) score ≥40 ved baseline;
- Clinical Global Impression Scale (CGI-S) score ≥ 4 ved baseline. Eksklusjonskriterier
1. Forekomst av en hvilken som helst komorbid psykisk lidelse ifølge DSM-5, annet enn angstlidelser; 2. MDD med psykotiske symptomer; 3. Young Mania Rating Scale (YMRS) >13 ved baseline; 4. Historie med nevrologiske lidelser (f.eks. epilepsi, traumatisk hjerneskade), eller forekomst av alvorlige fysiske sykdommer (f.eks. thyreoideasykdom, lupus erythematosus, diabetes mellitus, klinisk signifikant lunge-, lever- eller nyresvikt, eller større traume); 5. Ingen respons på minst to antidepressiva med forskjellige mekanismer, og hvert gitt i en tilstrekkelig dose og i en tilstrekkelig varighet; 6. Historie med intoleranse overfor sertralin eller ingen respons på en tilstrekkelig terapeutisk kurs med sertralin; 7. Nåværende høyt selvmordsrisiko; 8. Historie med alkohol- eller narkotikamisbruk eller -avhengighet; 9. Inntak eller administrering av antidepressiva innen 5 halveringstider; 10. Bruk av probiotisk-relatert mat eller medisin innen 2 uker før inkludering; 11. Systemisk bruk av antibiotika eller antimykotika innen 1 måned før inkludering; 12. Historie med alvorlig matallergi eller kjent overfølsomhet for Lactobacillus crispatus-preparatet eller noen av dets komponenter; 13. Følger vegetarianisme eller andre restriktive kostholdsmønstre; 14. Graviditet eller amming.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Sertralin kombinert med Lactobacillus crispatus-gruppen
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Fase 1 (uke 1-4): Sertralin vil startes med 25 mg/dag og doseres opp etter klinisk skjønn, med en tillatt doseringsrekkevidde på 25-150 mg/dag. Ved uke 4 vil sertralindosen nå minst 150 mg/dag. Samtidig vil Lactobacillus crispatus-pulver administreres med 1 pose/dag (1×10⁹ CFU/pose). Fase 2 (uke 5-8): Sertralin vil opprettholdes med 150-200 mg/dag, med dosejusteringer veiledet av psykiaterens kliniske skjønn. Lactobacillus crispatus-pulver vil forbli med 1 pose/dag (1×10⁹ CFU/pose). |
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Aktiv komparator: Sertralin kombinert med placebogruppe
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Fase 1 (uke 1-4): Sertralin vil bli startet med 25 mg/dag basert på psykiaterens kliniske vurdering, med en tillatt doseringsrekkevidde på 25-150 mg/dag. Ved uke 4 vil sertralindosen nå minst 150 mg/dag, med tilhørende placebopulver på 1 pose/dag. Fase 2 (uke 5-8): Sertralin vil bli opprettholdt på 150-200 mg/dag, med dosejusteringer veiledet av psykiaterens kliniske vurdering. Placebopulver vil bli opprettholdt på 1 pose/dag. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Children's Depression Rating Scale - Revised (CDRS-R) scores
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Baker Depression Scale（BDI） scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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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
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Change in Hamilton Anxiety Scale (HAMA）scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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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
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Change in Young Mania Rating Scale (YMRS) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Changes in Ruminative Response Scale (RRS) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Medication adherence
Tidsramme: Assessments will be performed at week 4, and week 8
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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
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Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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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
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline
Tidsramme: Assessments will be performed at baseline, Week 4, and Week 8
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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.
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Assessments will be performed at baseline, Week 4, and Week 8
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Changes in Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline
Tidsramme: Changes from baseline to week 4 and week 8
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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.
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Changes from baseline to week 4 and week 8
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Changes in Childhood Trauma Questionnaire (CTQ) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Changes in Clinical Global Impressions - Severity (CGI-S) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Changes in Clinical global impressions-improvement (CGI-I) scores from baseline
Tidsramme: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- zz2025-535-03
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