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Effekten af spektralt optimeret lys på kognitiv svækkelse ved større depressiv lidelse og dens neurobilleddannelsesmekanismer

2. juli 2026 opdateret af: Xiaozhen LV, Peking University Sixth Hospital

Effektiviteten af spektralt optimeret lys på kognitiv svækkelse ved major depression og dens neurobilleddannelsesmekanismer undersøgelse

Dette studie har til formål at validere den terapeutiske effektivitet og sikkerhed af spektralt optimeret lys (SOL) i forbedringen af kognitiv svækkelse (CI) ved alvorlig depressiv lidelse (MDD), karakterisere de funktionelle og strukturelle egenskaber af hippocampus (HPC)-dorsolaterale præfrontale cortex (dlPFC) neuronale kredsløb hos MDD-patienter med kognitiv svækkelse og undersøge den mediierende effekt af HPC-dlPFC neuronale kredsløb på de kognitive forbedringer induceret af SOL-behandling hos MDD-CI-patienter. Patienter med MDD-CI skal kun modtage selektive serotonin-genoptagelseshæmmere (SSRI'er) som primær medicin i mindst en uge eller ikke have modtaget nogen behandling før. SOL er en form for lysterapi (BLT). Kvalificerede deltagere vil blive tilfældigt tildelt eksperimentgruppen og kontrolgruppen. Eksperimentgruppen vil modtage intervention med BLT, og kontrolgruppen vil modtage intervention med svagt rødt lys (placebo). Interventionen vil vare i fire uger. Deltagerne vil blive fulgt op en gang om ugen under interventionen og i 4. uge efter interventionen. Demografiske oplysninger vil blive indsamlet ved baseline, kognitiv funktion vil blive evalueret ved baseline, 2., 4. og 8. weekend efter interventionsstart. og andre symptomer såsom depression, angst og søvn blev vurderet ved baseline, 1., 2., 3., 4. og 8. weekend efter interventionsstart. Desuden vil strukturelle og funktionelle MR-scanninger blive foretaget ved baseline og efter fire ugers intervention. Under interventionen vil patienter med MDD-CI føre daglig registrering af lyseksponeringens varighed, udfylde den daglige søvndagbog samt.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne undersøgelse var designet som en randomiseret kontrolleret undersøgelse. Den fokuserer på patienter med MDD-CI, hvor der blev etableret en eksperimentel gruppe og en kontrolgruppe. Den eksperimentelle gruppe blev behandlet med en af seks SSRIs, herunder Fluoxetin, Paroxetin, Sertralin, Citalopram, Fluvoxamin og Escitalopram. Medicinen forblev uændret gennem hele interventionen. Den eksperimentelle gruppe modtog interventionen BLT, og kontrolgruppen modtog yderligere interventionen med svagt rødt lys (placebo). Interventionen varer i fire uger (seks dage om ugen, 45 minutter om dagen mellem kl. 7 og 10). Opfølgning vil blive udført en gang ved den 4. weekend efter interventionen. Kognitiv vurdering vil blive udført ved hjælp af den kinesiske version af Measurement Consensus Cognitive Battery (MCCB), den kinesiske Biref Cognitive Test (C-BCT) og Perceived Deficits Questionnaire (PDQ) ved baseline samt ved 2., 4. og 8. weekend efter interventionens start. Andre kliniske symptomer vil blive vurderet ved hjælp af The 17-item Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Rating Scale (HAMA), Clinical Global Impression (CGI), Young Mania Rating Scale (YMRS), Quick Self Rating Depression Symptoms Scale (QIDS), 7-item Generalized Anxiety Disorder Scale (GAD-7), Pittsburgh Sleep Quality Index (PSQI), den kinesiske version af Short Form of Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) og Sheehan Disability Scale (SDS) ved baseline samt ved 1., 2., 3., 4. og 8. weekend efter interventionens start. Samtidig blev sikkerheden og anvendeligheden af interventionen under behandlingsforløbet undersøgt ved hjælp af Side Effects Rating Scale for Serotonin Specific Reuptake Inhibitors (SERS-SSRIs) og Treatment Compliance Record Form.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100191
        • Rekruttering
        • Peking University Sixth Hospital
        • Kontakt:
    • Shanxi
      • Yanan, Shanxi, Kina
        • Rekruttering
        • Yan'an Third People's Hospital
        • 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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusions- og eksklusionskriterier for MDD-patienter. 1、Inklusionskriterier:

  1. nuværende Diagnostic and Statistical Manual of Mental Disorders, femte udgave (DSM-5) diagnose af Major Depressive Disorder, første episode eller recidiv;
  2. alder 18-60 år; køn ikke-begrænset;
  3. sværhedsgraden af MDD-symptomer skal være >14 point på Hamilton Depression Rating Scale-17 (HAMD-17);
  4. med kognitiv dysfunktion i øjeblikket, defineret som en totalscore på ≤ 70 på Digit Symbol Substitution Test (DSST);
  5. berettigede patienter har modtaget Selective Serotonin Reuptake Inhibitors (SSRIs) i stabile doser i mindst 1 uge eller ej;
  6. uddannelsesniveau over folkeskole, i stand til at forstå og samarbejde om gennemførelse af undersøgelsesprocedurerne;
  7. frivilligt deltagelse i denne undersøgelse og underskrivelse af informeret samtykke før inddragelse.

2、Eksklusionskriterier:

  1. nuværende eller tidligere diagnose af enhver lidelse andet end major depressive disorder ifølge DSM-5-kriterier;
  2. scorerne på YMRS er >8;
  3. Personer, der har gennemgået anden intervention udover SSRIs inden for de seneste seks måneder eller nu, eller som planlægger at gøre det inden for en måned;
  4. Personer med stærk selvbeskyldning, selvskade eller selvmordstendenser (HDRS-17 selvmordsitem score ≥ 3);
  5. Personer med alvorlige fysiske sygdomme, inklusive hjertesvigt, nyresvigt, svær leversvigt, hyperthyreose eller hypothyreose; eller en historie med svær hjernetraume eller organisk hjernepatologi (f.eks. intrakraniel blødning, stort cerebralt infarkt, encephalitis, epilepsi), samt neurologiske sygdomme.
  6. Personer med enhver grad af retinal patologi, inklusive retinal dystrofi, aldersrelateret makuladegeneration, diabetisk retinopati, katarakt, glaukom eller andre øjensygdomme;
  7. Personer med lysfølsomme tilstande, såsom systemisk lupus erythematosus, porfyri, kronisk fotodermatitis, solurticaria, eller dem, der i øjeblikket modtager medicin, der kan øge lysfølsomhed (f.eks. fenotiaziner, antimalariamidler, propranolol, hypericin, stimulanter eller kronisk behandling med ikke-steroide antiinflammatoriske lægemidler).
  8. Gravide eller ammende kvinder;
  9. Personer med kontraindikationer mod magnetisk resonansscanning (MRI), såsom tilstedeværelse af ikke-MRI-sikre metalliske implantater eller klaustrofobi.
  10. Personer, der anses for uegnede til inddragelse i denne undersøgelse af undersøgeren af andre årsager.

Udgåelses- og afslutningskriterier:

  1. Deltagere opfylder et af ovenstående eksklusionskriterier efter inddragelse;
  2. nuværende personers behandlingsregime skal ændres;
  3. Deltagere, der ikke samarbejder eller frivilligt trækker sig fra undersøgelsen;
  4. På grund af alvorlige bivirkninger er deltagerne ude af stand til at tolerere fototerapi.
  5. Deltagere, der ikke overholder undersøgelsesprotokolinterventionen i tre på hinanden følgende dage eller i en kumulativ varighed på over syv dage;
  6. Annullering af undersøgelsen.

Inklusions- og eksklusionskriterier for raske kontroller

1. Inklusionskriterier

  1. alder 18-60 år; køn ikke-begrænset; og højrehåndet;
  2. uden kognitiv dysfunktion i øjeblikket, defineret som en totalscore på ≤ 70 på Digit Symbol Substitution Test (DSST);
  3. uddannelsesniveau over folkeskole, i stand til at forstå og samarbejde om gennemførelse af undersøgelsesprocedurerne;
  4. frivilligt deltagelse i denne undersøgelse og underskrivelse af informeret samtykke før inddragelse.

2. Eksklusionskriterier

  1. Nuværende eller livstidsdiagnose af enhver psykiatrisk lidelse, eller historie med stof-/stofmisbrug eller afhængighed;
  2. I øjeblikket eller tidligere diagnosticeret med alvorlige somatiske sygdomme, såsom hjertesvigt, nyresvigt, svær leversvigt eller hyperthyreose/hypothyreose;
  3. historie med svær traumatisk hjerneskade eller organiske hjernelæsioner;
  4. Gravide eller ammende kvinder;
  5. Personer med kontraindikationer mod magnetisk resonansscanning (MRI), såsom tilstedeværelse af ikke-MRI-sikre metalliske implantater eller klaustrofobi.
  6. Personer, der anses for uegnede til inddragelse i denne undersøgelse af undersøgeren af andre årsager.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: sund kontrol
Placebo komparator: DRL control group
Eligible MDD participants will be randomly subjected to the DRL control group. The light source intensity will be set at <100 lux and placed 0.6 meters away from the MDD participant. They will be required to staring at the light source for 2 seconds every 5 minutes. The DRL control group will be administered for 40 minutes each day between 7:00 AM and 10:00 AM, lasting for four weeks, 6 days per week.
Enhed: DRL
Using a dim red light box as the placebo, with an intensity of <100lux and a main wavelength of 690.4nm
Eksperimentel: BLT experimental group
Eligible MDD participants will be randomly subjected to the BLT experimental group. The source intensity of BLT experimental group will be set at 10000 lux and placed 0.45 meters away from the MDD participant. They will be required to staring at the light source for 2 seconds every 5 minutes. The BLT experimental group will be administered for 40 minutes each day between 7:00 AM and 10:00 AM, lasting for 4 weeks, 6 days per week.
Enhed: BLT
Using a hybrid white light box with independent intellectual property rights, with an intensity of 10000lux and a main wavelength of 476.4nm

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Symbol Coding (SC)
Tidsramme: screen, baseline, weeks2, 4, and 8
The Symbol Coding (SC) is a coding paradigm adapted from the Digit Symbol Substitution Test (DSST), both of which use essentially the same method, except in reverse; instead of drawing symbols that match digits, the SC requires to write the matching digit in the blank. The task has been included as a subtest in the Brief Assessment of Cognition in Schizophrenia; in this task, subjects are required to write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 s, as based on a key provided to them, with higher scores reflecting better performance.
screen, baseline, weeks2, 4, and 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hamilton Depression Rating Scale-17（HDRS-17）
Tidsramme: screen, baseline, weeks1, 2, 3, 4, and 8
The Hamilton Depression Rating Scale-17 (HAMD-17), developed by Hamilton in 1960, is a widely used clinical rating scale consisting of 17 items that evaluate various depressive symptoms, including mood, suicidal thoughts, sleep disturbances, loss of interest, psychomotor changes, anxiety, gastrointestinal and somatic symptoms, sexual dysfunction, and weight loss. Scored on a scale of 0 to 4 (with some items possibly using a 0 to 2 scale), the total score reflects the severity of depressive symptoms and is used for diagnosing depression, planning tailored treatment, monitoring treatment effectiveness, and conducting research on depression treatment efficacy.
screen, baseline, weeks1, 2, 3, 4, and 8
The 20-item Perceived Deficits Questionnaire for Depression（PDQ-D-20）
Tidsramme: baseline, weeks 2, 4, and 8
The Chinese version of the Perceived Deficits Questionnaire for Depression (PDQ-D) has been validated for reliability and validity among patients with depression in China. The PDQ-D comprises 20 items, yielding a total score that ranges from 0 to 80. Higher scores indicate a greater severity of self-perceived cognitive symptoms. Demonstrating good reliability and validity, the questionnaire assesses patients' cognitive function across four dimensions: attention/concentration, prospective memory, retrospective memory, and planning and organization.
baseline, weeks 2, 4, and 8
The Chinese Brief Cognitive Test（CBCT）
Tidsramme: baseline, weeks 2, 4, and 8
Cognitive function will be also assessed using the CBCT, which has been validated in a large-scale study of schizophrenia patients and has shown good internal consistency and test-retest reliability. Also, additional studies in MDD population provide further evidence of its reliability and validity supporting the robustness of this scale for assessing cognitive function in these clinical groups.
baseline, weeks 2, 4, and 8
Stroop Color-Word Test (SCWT)
Tidsramme: baseline, weeks 2, 4, and 8
The Stroop Color Word Test (SCWT) was developed by Professor Stroop in 1935 to evaluate subjects' executive functions. The test is a measure of selective attention and the degree of inhibition of irrelevant information in executive functioning. It consists of three main parts: reading words (Stroop-w), color naming (Stroop-c), and color-word interference (Stroop-cw), which require subjects to accurately and quickly read the words or the colors, respectively, as required.
baseline, weeks 2, 4, and 8
Hopkins Verbal Learning Test-Revised (HVLT-R)
Tidsramme: baseline, weeks 2, 4, and 8
Hopkins Verbal Learning Test-Revised (HVLT-R) is a widely used neuropsychological assessment tool designed to evaluate verbal memory and cognitive function. Developed by J. Brandt and Benedict in 2001, the HVLT-R consists of a list of 12 nouns divided into three semantic categories (e.g., dwelling places, four-legged animals, and precious stones), with four words per category. The assessment involves three learning trials, where participants are presented with the list of words and are asked to recall as many words as possible immediately after each presentation. Additionally, there is a delayed recall trial, where participants are asked to recall the words after a delay of 20-25 minutes. The scoring principle is based on the number of correctly recalled words during each learning trial and the delayed recall trial. The total score for the three learning trials and the delayed recall trial is calculated as well.
baseline, weeks 2, 4, and 8
Generalized Anxiety Disorder-7（GAD-7）
Tidsramme: baseline, weeks1, 2, 3, 4, and 8
The Generalized Anxiety Disorder-7 is a standardized assessment tool developed by Spitzer et al. in 2006. It is a 7-item questionnaire designed to evaluate the severity of anxiety symptoms over the past two weeks. The scale covers various aspects of anxiety, including feelings of tension, worry, irritability, and difficulty relaxing. Each item is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms. The GAD-7 is primarily used as a screening and assessment tool in clinical and research settings, aiding clinicians in identifying and quantifying anxiety symptoms, monitoring changes over time, and evaluating treatment effectiveness. It is a simple, reliable, and valid instrument that can be easily administered and scored, making it a valuable addition to the clinical assessment of anxiety disorders.
baseline, weeks1, 2, 3, 4, and 8
Quick Inventory of Depressive Symptomatology-Self-Report（QIDS-SR-16）
Tidsramme: baseline, weeks1, 2, 3, 4, and 8
The Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), a rigorous and systematic self-assessment scale developed by Rush et al. in 2003 with subsequent refinements, is a widely recognized tool for quickly gauging depressive symptoms over the past week. It comprises 16 items covering various dimensions of depression, including mood, sleep, appetite, energy levels, concentration, self-esteem, suicidal ideation, and daily functioning, each rated on a 4-point scale (0-3). The scale assesses the severity and frequency of symptoms, with higher scores indicating more severe depression. The QIDS-SR16 serves multiple purposes: it aids in screening and assessing depressive symptoms in clinical settings, allows individuals to monitor their depressive state over time, serves as a research tool in clinical studies evaluating treatment effectiveness, and provides valuable information that can support the diagnostic process when combined with clinical interviews.
baseline, weeks1, 2, 3, 4, and 8
Pittsburgh Sleep Quality Inventory（PSQI）
Tidsramme: baseline, weeks1, 2, 3, 4, and 8
The PSQI, or Pittsburgh Sleep Quality Inventory, was developed by Buysse et al. in 1989. It is a widely used and standardized self-report questionnaire designed to assess sleep quality over the past month. The PSQI consists of 19 self-rated items and 5 additional items for bed partner or roommate ratings (though only 18 of the self-rated items are scored). The assessment covers seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a 0-to-3 scale, with the total PSQI score ranging from 0 to 21. Higher scores indicate poorer sleep quality, with a total score of 5 or less indicating good sleep quality, 6-10 indicating fair sleep quality, 11-15 indicating poor sleep quality, and 16 or more indicating very poor sleep quality. The PSQI serves multiple purposes, including clinical diagnosis of sleep disorders, research on sleep quality, and eval
baseline, weeks1, 2, 3, 4, and 8
Young Mania Rating Scale（YMRS）
Tidsramme: screen, baseline, weeks1, 2, 3, 4, and 8
The Young Mania Rating Scale (YMRS), developed by R.C. Young and colleagues in 1978, is a clinician-administered rating scale designed to assess the severity of manic symptoms over the past week. It comprises 11 items that evaluate various aspects of mania, including elevated mood, increased activity and energy, sexual interest, sleep pattern, irritability, speech, language-thought disorders, content of thought, aggressive or destructive behavior, appearance, and insight. The scoring system varies across items, with some rated on a 0-4 scale and others on a 0-8 scale. The total score is obtained by summing the ratings of all items, providing a quantitative measure of manic severity. Higher scores indicate more severe manic symptoms. The YMRS is primarily used in clinical and research settings for the assessment of manic states.
screen, baseline, weeks1, 2, 3, 4, and 8
Asberg Side-Effect Rating Scale for Antidepressants (SERS)
Tidsramme: baseline, weeks1, 2, 3, 4, and 8
Asberg Side-Effect Rating Scale for Antidepressants (SERS) is a rating scale developed by Swedish psychiatrist M. Asberg in 1970. It is specifically designed to evaluate the adverse effects experienced by individuals following the administration of antidepressant medications. The scale contains 14 items that assess a wide range of symptoms, including physical fatigue, dizziness, headache, sleep disturbance, orthostatic hypotension, palpitations, tremors, sweating, dry mouth, constipation, urinary difficulties, somnolence, sexual dysfunction, and other symptoms. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe), allowing for a comprehensive quantification of the severity of side effects. The total score, calculated by summing the ratings of all items, provides an overall measure of antidepressant-related adverse effects. The SERS is primarily used in clinical and research settings to aid in the identification, monitoring, and documentation of side effects.
baseline, weeks1, 2, 3, 4, and 8
Quality of Life Enjoyment and Satisfaction Questionnaire,Short Form（Q-LES-Q-SF）
Tidsramme: baseline, weeks1, 2, 3, 4, and 8
The Q-LES-Q-SF, developed by Endicott et al. in 1995, consists of 16 items that assess an individual's subjective satisfaction with their quality of life over the past 7 days. The first 14 items reflect various aspects of quality of life, including physical and mental health, mood, work, household responsibilities, social relationships, family relationships, leisure activities, daily living skills, sexual functioning, financial status, living environment, mobility, hobbies, and overall subjective satisfaction with physical and mental health. Items 15 and 16 assess daily medical care and overall life satisfaction. Each item is rated on a scale from 1 to 5, with higher scores indicating better quality of life. The overall score for the Q-LES-Q-SF is derived from the sum of the scores from items 1 to 14.
baseline, weeks1, 2, 3, 4, and 8
Sheehan disability scale (SDS)
Tidsramme: baseline, weeks1, 2, 3, 4, and 8
The SDS evaluates the impact of depression on a patient's work, social life, and family responsibilities. The total score ranges from 0 to 30, with higher scores indicating greater functional impairment . The SDS has demonstrated strong reliability and validity in depressed populations.
baseline, weeks1, 2, 3, 4, and 8
Hamilton Anxiety Scale (HAMA）
Tidsramme: Baseline, week 1, 2, 3, 4 and 8
Originally developed by Hamilton in 1959, the HAMA is a classic clinician-administered questionnaire assessing both somatic and psychic anxiety severity. The 14-item instrument captures psychic anxiety (items 1-6, 14) and somatic anxiety (items 7-13). Each item is rated on a 5-point Likert scale from 0 (absent) to 4 (very severe), with higher total scores indicating more severe clinical anxiety. The construct validity and reliability of the Chinese HAMA adaptation have been rigorously established in domestic psychometric studies.
Baseline, week 1, 2, 3, 4 and 8
Insomnia Severity Index (ISI）
Tidsramme: Baseline, week 1, 2, 3, 4 and 8
The Insomnia Severity Index (ISI) is a standardized tool used to assess the severity of insomnia symptoms and their impact on daily life. It consists of 7 items that encompass difficulties in falling asleep, sleep maintenance, early awakening, satisfaction with sleep, distress caused by symptoms, impairment of daily functioning, and concern about insomnia. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. A higher score indicates more severe insomnia issues.
Baseline, week 1, 2, 3, 4 and 8
Color Trails Test （CTT）
Tidsramme: Baseline, week 2, 4 and 8

The Color Trails Test (CTT) (Maj, D'Elia, Satz, Janssen, Zaudig, Uchiyama et al., 1993; D'Elia, Satz, Uchiyama & White, 1996) is a language-free version of the Trail Making Test (TMT) that was developed to allow for broader cross-cultural application to measure sustained attention and divided attention in adults.The CTT is comprised of two tasks: CTT-1 must be administered first and requires the respondent to connect circles in an ascending numbered sequence (1-25).

CTT-2 must follow the CTT1 and requires the respondent to connect numbers in an ascending sequence while alternating between pink and yellow colors. Numbers are presented twice, once in pink and once in yellow, so the client must ignore the distracter item (e.g. start at pink 1, avoid pink 2 to select yellow 2, avoid yellow 3 to select pink 3, etc.).
Baseline, week 2, 4 and 8

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Digit Symbol Substitution Test (DSST)
Tidsramme: skærm
Digit Symbol Substitution Test (DSST), en kodningsopgave, hvor cifre erstattes med et simpelt symbol. Opgaven involverer opmærksomhed, behandlingshastighed og eksekutive funktioner og har vist følsomhed over for ændringer i MDD-populationer.22 DSST-score beregnes som det samlede antal korrekte symboler inden for en 90-sekunders periode (mulig scoreinterval 0-133), hvor højere score reflekterer bedre præstation.
skærm

Samarbejdspartnere og efterforskere

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

Sponsor

Peking University Sixth Hospital

Efterforskere

  • Ledende efterforsker: Xiaozhen Lv, Ph.D, Peking University Sixth Hospital

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)

10. april 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

27. marts 2026

Først indsendt, der opfyldte QC-kriterier

27. marts 2026

Først opslået (Faktiske)

2. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7262156

Plan for individuelle deltagerdata (IPD)

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