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Phototherapy in Young People With Depression

14. maj 2015 opdateret af: Rébecca Robillard, University of Ottawa

Phototherapy in Young People With Depression; Investigating Associations Between Changes in Actigraphic Sleep-wake Profile and Depressive Symptoms

Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered.

The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Suspenderet
        • Brain and Mind Research Insitute, The University of Sydney
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 7K4
        • Rekruttering
        • Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa
        • 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

13 år til 30 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Quick Inventory of Depressive Symptomatology score > 6;
  2. First episode of depression before age 25;
  3. Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic.

Exclusion Criteria:

  1. Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;
  2. Other primary psychiatric disorders aside from anxiety disorders;
  3. Significant alcohol or other substance dependence;
  4. Use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study);
  5. Use of medications that may interact with light to produce a photoallergic reaction;
  6. Eye or skin condition which may interact with bright light exposure;
  7. Regular shift-work within 60-days prior to entry into the study;
  8. Recent transmeridian travel.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Phototherapy
Enhed: Phototherapy light-emitting glasses

The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m^2) upon awakening and progressive shift to earlier wake-up times.

Participants are encouraged to complete the light exposure sessions for 60 min each day. Participants are also instructed to progressively shift their schedule 15 min earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7:30am is reached (in which case, participants keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they do the light exposure sessions upon awakening across the four weeks of the intervention.

During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls.

Andre navne:
  • Re-timer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severity of Depression
Tidsramme: Between baseline and post (4 weeks) intervention
Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Between baseline and post (4 weeks) intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severity of Depression
Tidsramme: Score between baseline and follow up (8 weeks)
Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Score between baseline and follow up (8 weeks)
Associations between Changes in Sleep-Wake Profile and Changes in Severity of Depression
Tidsramme: Between baseline and post (4 weeks) intervention
Associations between changes in sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Between baseline and post (4 weeks) intervention
Associations between Initial Sleep-Wake Profile and Changes in Severity of Depression
Tidsramme: Baseline and post (4 weeks) intervention
Associations between the initial sleep-wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Baseline and post (4 weeks) intervention
Subjective Sleep Quality
Tidsramme: Between baseline and post (4 weeks) intervention
Change in Leeds Sleep Evaluation Questionnaire score
Between baseline and post (4 weeks) intervention
Fatigue Severity
Tidsramme: Between baseline and post (4 weeks) intervention
Change in Fatigue Severity Scale score
Between baseline and post (4 weeks) intervention

Samarbejdspartnere og efterforskere

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

Sponsor

University of Ottawa

Samarbejdspartnere

University of Sydney

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

1. april 2015

Primær færdiggørelse (Forventet)

1. april 2017

Datoer for studieregistrering

Først indsendt

14. maj 2015

Først indsendt, der opfyldte QC-kriterier

14. maj 2015

Først opslået (Skøn)

19. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2015007

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med Phototherapy light-emitting glasses

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jamaica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner