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Ketogen diet och neuromodulering vid behandlingsresistent depression (ALIGN)

4 augusti 2026 uppdaterad av: Dr. Sean Michael Nestor, Sunnybrook Health Sciences Centre

Adjuvant lågkolhydrat ketogen diet för att förbättra bildvägledd neuromodulering vid behandlingsresistent depression

Syftet med denna kliniska studie är att testa om kombinationen av en ketogen diet (KD) med personanpassad, accelererad intermittent theta burst-stimulering (iTBS) ger större minskning av depressiva symptom än iTBS kombinerat med en standardhälsodiet hos vuxna med behandlingsresistent depression. Studien syftar också till att avgöra om deltagarna kan följa en ketogen diet genomförbart under en accelererad iTBS-behandlingskurs och om dieten producerar mätbara förändringar i ketonnivåer.

Specifikt syftar studien till att avgöra om den kombinerade interventionen:

  1. Minskar depressiva symptom
  2. Ökar cirkulerande ketonnivåer
  3. Är genomförbar och tolerabel under accelererad iTBS-behandling

Deltagarna kommer att påbörja antingen en KD eller en diet i enlighet med Canadian Food Guide (CFGD) med en 3-veckors dietinledningsperiod, varefter de kommer att genomgå en kurs av personanpassad, accelererad iTBS samtidigt som de fortsätter sin tilldelade diet. Före och efter iTBS-behandlingskursen kommer deltagarna att genomföra kliniska bedömningar, lämna blodprover för metabolisk testning och genomgå MR-avbildningar för att bedöma hjärnans konnektivitet. Ketonnivåer kommer att mätas dagligen under hela den 15-veckorslånga dietinterventionen. Inom-grupps- och mellan-gruppsskillnader kommer att jämföras för att karakterisera förändringar i kliniska utfall, metabolism och hjärnfunktion.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M4N 3M5
        • Sunnybrook Health Sciences Centre
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Ålder 18-65 år av vilket kön, könsidentitet, etnicitet och socioekonomisk status som helst
  • För närvarande upplever en större depressiv episod enligt DSM-5-TR-kriterier och bekräftad av en studieansvarig läkare
  • Uppvisar minst måttlig symtomgravitet (MADRS ≥ 20)
  • Uppfyller kriterierna för behandlingsresistent depression (TRD), definierad som bristande respons på minst två adekvata antidepressiva behandlingsförsök
  • Neuromodulationsnaiv (ingen tidigare rTMS eller elektrokonvulsiv terapi)
  • Kapabel att ge informerat samtycke
  • Tillgänglig för den 15-veckorslånga interventionen och villig att följa antingen en ketogen eller en kanadensisk matguide-anpassad kost

Exklusionskriterier:

  • Medicinska/psykiatriska komorbiditeter som förhindrar deltagande i studien eller där depression inte är det primära psykiatriska symtomet av betydelse
  • Historik av epilepsi, stroke eller större neurologiska tillstånd, psykos eller substansberoende inom de senaste 6 månaderna
  • Fysiskt eller kognitivt funktionshinder som stör deltagande
  • Kvinnor som är gravida (självrapporterat eller via blodprov), ammar eller planerar graviditet under studieperioden BMI < 20 kg/m²
  • Självmordsförsök under de senaste 12 månaderna
  • Aktiv självmordsavsikt bekräftad av studiens psykiater
  • Aktiv ätstörning under de senaste 12 månaderna
  • Följer för närvarande en ketogen kost
  • Vanemässigt lågkolhydratkost under de senaste 6 månaderna
  • GI-störningar eller matallergier oförenliga med kostprotokollen
  • Alkoholkonsumtion >3 drinkar/dag eller >14/vecka
  • Användning av antikonvulsiva (bensodiazepiner med dos <2 lorazepamekvivalenter tillåts), GABA-agonister eller läkemedel som minskar TMS-effektiviteten
  • Allvarlig medicinsk sjukdom
  • Kontraindikationer mot MR
  • Ovilja att utföra daglig fingersticketestning

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Ketogenic Diet
Participants in this arm will follow a well-formulated ketogenic diet (low carbohydrate, moderate protein, high fat) for a 3-week dietary lead-in period prior to neuromodulation, and will continue the diet for a total of 12 weeks. The diet is designed to achieve and maintain nutritional ketosis (blood ketone levels of 0.5 to 3 mmol/L). Dietitian support will be provided through scheduled counseling and ongoing monitoring of finger-stick ketone and glucose testing.
Enhet: Accelerated Intermittent Theta Burst Stimulation (iTBS)
Intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), is a non-invasive brain stimulation technique approved by the FDA and Health Canada for the treatment of TRD. In this study, participants will receive an accelerated course of imaging-guided, neuronavigated left dorsolateral prefrontal cortex (DLPFC) iTBS targeted based on functional connectivity with the subgenual anterior cingulate cortex (sgACC). Stimulation protocol consists of 1800 pulses per session, delivered at 110% of resting motor threshold, with 50-minute inter-session intervals, for 8 sessions per day over 5 consecutive days.
Andra namn:
  • repetitiv transkraniell magnetisk stimulering (rTMS)
Beteende: Ketogenic Diet
A well-formulated ketogenic diet consisting of low carbohydrate, moderate protein, and high fat intake, designed to achieve and maintain nutritional ketosis (blood ketone levels of 0.5 to 3 mmol/L). Delivered with dietitian-led counseling and monitored via finger-stick ketone and glucose testing.
Aktiv komparator: Canadian Food Guide-Aligned Diet
Participants in this arm will follow a Canadian Food Guide-aligned diet for a 3-week dietary lead-in period prior to neuromodulation and will continue the diet for a total of 12 weeks. The diet will emphasize balanced intake of vegetables, fruits, whole grains, and protein foods, without specific macronutrient restrictions. Dietitian counseling will be approximately matched in frequency and duration to the ketogenic diet arm. Nutritional monitoring will include dietary logs and metabolic assessments without targeted induction of ketosis. Participants will perform finger-stick glucose testing.
Enhet: Accelerated Intermittent Theta Burst Stimulation (iTBS)
Intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), is a non-invasive brain stimulation technique approved by the FDA and Health Canada for the treatment of TRD. In this study, participants will receive an accelerated course of imaging-guided, neuronavigated left dorsolateral prefrontal cortex (DLPFC) iTBS targeted based on functional connectivity with the subgenual anterior cingulate cortex (sgACC). Stimulation protocol consists of 1800 pulses per session, delivered at 110% of resting motor threshold, with 50-minute inter-session intervals, for 8 sessions per day over 5 consecutive days.
Andra namn:
  • repetitiv transkraniell magnetisk stimulering (rTMS)
Beteende: Canadian Food Guide-Aligned Diet
A Canadian Food Guide-aligned diet emphasizing balanced intake of vegetables, fruits, whole grains, and protein foods, without specific macronutrient restrictions. Delivered with dietitian counseling matched in frequency and duration to the ketogenic diet arm, and monitored via dietary logs, metabolic assessments, and finger-stick glucose testing.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Change in depression symptomatology as assessed by the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS). Higher scores indicate worse outcomes (greater severity of depressive symptoms)
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Changes in Ketone Levels
Tidsram: Baseline through week 12
Change in β-hydroxybutyrate concentrations over the treatment period relative to baseline. β-hydroxybutyrate will be measured daily via finger-stick ketone testing during the lead-in and iTBS phases, and a minimum of three times per week during the post-iTBS dietary continuation phase. Longitudinal change will be analyzed across the treatment period.
Baseline through week 12
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Tidsram: Baseline through week 12
Frequency, severity, and relatedness of adverse events and clinically significant laboratory abnormalities, and discontinuations due to adverse effects, with specific attention to KD-related effects (e.g., hypoglycemia, dehydration, electrolyte disturbances, gastrointestinal symptoms, dyslipidemia) and mood destabilization/suicidality.
Baseline through week 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Behandlingsförväntan
Tidsram: Baslinje
Behandlingsförväntan kommer att bedömas med hjälp av Stanford Expectations of Treatment Scale (SETS), som administreras vid baseline för att utvärdera deltagarnas förväntningar före interventionen. Högre poäng på SETS indikerar starkare positiv behandlingsförväntan.
Baslinje
Changes in ¹H-MRS Neurochemical Metabolites
Tidsram: Baseline to Week 8 (post-iTBS)
Proton magnetic resonance spectroscopy will quantify changes in metabolites associated with neuroplasticity and metabolic function. Metabolite concentrations will be compared from baseline to post-treatment to determine whether nutritional ketosis enhances neurochemical responses to iTBS.
Baseline to Week 8 (post-iTBS)
Changes in Resting-State Functional Connectivity
Tidsram: Baseline to Week 8 (post-iTBS)
Resting-state fMRI will be used to assess changes in intrinsic functional connectivity within fronto-cingulate and fronto-striatal networks.
Baseline to Week 8 (post-iTBS)
Changes in Task-Evoked Brain Activation
Tidsram: Baseline to Week 8 (post-iTBS)
Task-based fMRI will be used to measure changes in activation within predefined mood-regulation circuits. Contrast maps from an emotional processing task will be compared from baseline to post-treatment to assess neural circuit engagement associated with iTBS combined with dietary intervention.
Baseline to Week 8 (post-iTBS)
Change in Secondary Depression Scores
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Baseline grid-version of the 17-item Hamilton Depression Rating Scale (HDRS) score. The HDRS is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range is 0 to 52, with higher score indicating more severe depression.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Change in Self-Reported Depressive Symptoms
Tidsram: Baseline, Week 3 (pre-iTBS), Week 5 (post-iTBS), Week 8 (post-iTBS), Week 10 (post-iTBS), Week 12 (post-iTBS), Week 26 (post-iTBS), Week 52 (post-iTBS)
Self-reported depressive symptom severity will be assessed using the PHQ-9 with changes measured from baseline to each assessment point through the end of treatment. Higher scores on the PHQ-9 represent greater depressive severity.
Baseline, Week 3 (pre-iTBS), Week 5 (post-iTBS), Week 8 (post-iTBS), Week 10 (post-iTBS), Week 12 (post-iTBS), Week 26 (post-iTBS), Week 52 (post-iTBS)
Functional Disability
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS), Week 26 (post-iTBS), Week 52 (post-iTBS)
Functional disability will be measured using the WHODAS 2.0, with changes evaluated from baseline to the end of treatment. Higher WHODAS scores indicate greater impairment.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS), Week 26 (post-iTBS), Week 52 (post-iTBS)
Well-being
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS), Week 26 (post-iTBS), Week 52 (post-iTBS)
Well-being will be evaluated using the WHO-5 Well-Being Index, measured from baseline to the end of treatment. Higher WHO-5 scores represent better well-being.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS), Week 26 (post-iTBS), Week 52 (post-iTBS)
Change in Anxiety Measure
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS), Week 26 (post-iTBS), Week 52 (post-iTBS)
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), with improvement examined from baseline to the end of treatment. Higher GAD-7 scores reflect more severe anxiety
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS), Week 26 (post-iTBS), Week 52 (post-iTBS)
BMI (Anthropometric Outcomes)
Tidsram: Baseline, Day 5 (post-iTBS), Week 5 (post-iTBS), Week 8 (post-iTBS)
Anthropometric outcomes, including BMI, will be recorded to evaluate changes in adiposity and fat distribution from baseline to the end of treatment.
Baseline, Day 5 (post-iTBS), Week 5 (post-iTBS), Week 8 (post-iTBS)
Waist-to-Hip Ratio (Anthropometric Outcomes)
Tidsram: Baseline, Day 5 (post-iTBS), Week 5 (post-iTBS), Week 8 (post-iTBS)
Anthropometric outcomes, including waist circumference and waist-to-hip ratio, will be recorded to evaluate changes in adiposity and fat distribution from baseline to the end of treatment. Higher waist-to-hip ratios indicate greater central adiposity.
Baseline, Day 5 (post-iTBS), Week 5 (post-iTBS), Week 8 (post-iTBS)
NIH Toolbox Dimensional Change Card Sort Test (Executive Functioning)
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Executive functioning will be assessed using the NIH Toolbox Dimensional Change Card Sort Test, with changes evaluated from baseline to the end of treatment. Higher scores reflect better cognitive performance.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
NIH Flanker Inhibitory Control and Attention Test (Executive Functioning)
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Executive functioning will be assessed using the NIH Flanker Inhibitory Control and Attention Test, with changes evaluated from baseline to the end of treatment. Higher scores reflect better cognitive performance.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Working Memory
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Working memory will be measured using the NIH Toolbox List Sorting Working Memory Test, with changes compared from baseline to post-treatment. Higher scores indicate stronger working memory ability.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Episodic Memory
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Episodic memory will be assessed using the NIH Toolbox Auditory Verbal Learning Test and the Picture Sequence Memory Test, with changes evaluated from baseline to the end of treatment. Higher scores indicate better episodic memory performance.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Waist-to-Hip Ratio (Anthropometric outcome)
Tidsram: Baseline, Day 5 (post-iTBS), Week 5 (post-iTBS), Week 8 (post-iTBS)
Anthropometric outcomes, including waist circumference and waist-to-hip ratio, will be recorded to evaluate changes in adiposity and fat distribution from baseline to the end of treatment. Higher waist-to-hip ratios indicate greater central adiposity.
Baseline, Day 5 (post-iTBS), Week 5 (post-iTBS), Week 8 (post-iTBS)
NIH Toolbox Oral Symbol Digit Test (Processing Speed)
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Processing speed will be evaluated using the NIH Toolbox Oral Symbol Digit Test, with changes assessed from baseline to post-treatment. Higher scores reflect faster processing speed.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
NIH Toolbox Pattern Comparison Processing Speed Test (Processing Speed)
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Processing speed will be evaluated using the NIH Toolbox Pattern Comparison Processing Speed Test, with changes assessed from baseline to post-treatment. Higher scores reflect faster processing speed.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Perceived Physical Capacity
Tidsram: Baseline, Days 1-5 of iTBS treatment, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
The modified Rating of Perceived Exertion (RPE) scale will be used to assess participants' perceived physical effort and tolerance during routine physical activities and daily tasks. This subjective measure captures how hard the body feels it is working based on internal sensations such as breathing, cardiovascular strain, muscle fatigue, and overall exertion, providing an index of perceived functional capacity for physical activity.
Baseline, Days 1-5 of iTBS treatment, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Objective Physical Capacity
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Objective indices of physical capacity and fatigue will be obtained using handgrip dynamometry. Maximal voluntary force (MVF) will be measured as the average of three maximal-effort trials, reflecting peak isometric grip strength and overall neuromuscular capacity of the hand and forearm muscles.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Fatigue
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Time to exhaustion (TTE) during a sustained submaximal grip task will be used to quantify fatigue resistance and endurance, defined as the duration for which participants can maintain a prescribed grip force before they are unable to sustain the target level.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Change in HbA1c Levels
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in fasting HbA1c (measured in mmol/mol) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in Fasting Glucose Levels
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in fasting glucose (measured in mmol/L) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in Lipid Profile
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in lipid profile (total cholesterol, LDL, HDL, triglycerides; measured in mmol/mol) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in Liver Function Panel
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in liver function (ALT, AST, ALP; measured in U/L) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in Total Protein and Albumin
Tidsram: Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Changes in total protein and albumin (measured in g/L) across the study period.
Baseline, Week 5 (post-iTBS), Week 8 (post-iTBS), Week 12 (post-iTBS)
Change in Total Bilirubin
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in total bilirubin (measured in mg/dL) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in Electrolytes
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in electrolytes (measured in mmol/L) across the study period
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in Urea and Calcium
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in urea and calcium (measured in mg/dL) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in BDNF
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in BDNF (measured in ng/mL) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in IL-6 and TNF-alpha Levels
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in inflammatory markers (measured in pg/mL) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Change in CRP Levels
Tidsram: Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)
Changes in CRP (measured in mg/L) across the study period.
Baseline, Day 1 of iTBS, Week 5 (post-iTBS), Week 8 (post-iTBS)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sunnybrook Health Sciences Centre

Samarbetspartners

Baszucki Group

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 januari 2028

Avslutad studie (Beräknad)

1 januari 2028

Studieregistreringsdatum

Först inskickad

21 januari 2026

Först inskickad som uppfyllde QC-kriterierna

21 januari 2026

Första postat (Faktisk)

29 januari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 6944

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JA

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Avidentifierade individuella deltagardata (IPD) och relevant stöddokumentation (inklusive studieprotokoll, statistisk analysplan och datordlista) kommer att delas för att möjliggöra sekundär forskning. Data kommer att delas med kvalificerade forskare för vetenskapligt hållbara analyser, under förutsättning av godkännande och undertecknande av ett dataanvändningsavtal i enlighet med Sunnybrook Research Institutes policyer. Förfrågningar om tillgång kommer att granskas för att säkerställa vetenskapligt värde, genomförbarhet och skydd av deltagarnas konfidentialitet.

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Godkända användare kommer att få tillgång genom säkra, institutionellt godkända datadelingssystem. Alla användare måste underteckna ett dataanvändningsavtal som förbjuder re-identifiering, vidaredelning och all användning utanför det godkända förslaget.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

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