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Stress Sensitivity and Reward Responsivity in Depression (CAN-BIND-04)

26. august 2019 opdateret af: Dr. Kate Harkness

Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression

The goal of this project is to learn more about the different ways in which people process information that is stressful and rewarding, and how abnormalities in these two processes are related to depression.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Participants will participate in two 3-hour sessions separated by a week at Providence Care, Mental Health Services, and a third, 1.5-hour session at the Queen's MRI Facility. At the first session participants will complete a packet of questionnaires about their mood and take part in an interview about their mood, medications, drug use, and any other symptoms, as well as an interview about their relationships with their parents and any experiences of abuse. At the second session participants will participate in a stress test, which involves giving a speech to a panel. The investigators will also collect saliva samples to look at stress hormones. Participants will also complete a task on the computer that involves looking at cartoon faces and making decisions about them. At the third session, the investigators take images of of participant's brain using a magnetic resonance scanner.

Participants are invited to participate in a 6-month follow-up for this study, which would involve the same procedure as outline above.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

219

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Queen's University

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Community sample

Beskrivelse

For Depressed Participants:

Inclusion Criteria:

  • Outpatients aged 18-65
  • Currently suffering from unipolar depression
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires

Exclusion Criteria:

  • Clinical diagnosis of bipolar disorder, psychotic disorders, current alcohol/substance dependence, or significant medical comorbidity
  • Treatment-resistant (defined as failing more than 3 trials of anti-depressant medication)
  • History of neurological insult (e.g., concussion), neurological disease, seizure disorder
  • Smokers
  • Pregnant women
  • Endocrine disorders
  • High suicidal risk, defined by clinician judgement

For Healthy Control Participants:

Inclusion Criteria:

  • Adults aged 18-65
  • No history of Axis I disorders according to DSM-IV-TR criteria, as determined by the SCID
  • No first-degree relatives diagnosed with bipolar disorder
  • Fluency in English, sufficient to complete the interviews and self-report questionnaires

Exclusion Criteria:

  • History of neurological insult (e.g., concussion), neurological disease, seizure disorder
  • Smokers
  • Pregnant women
  • Endocrine disorders

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Depressed Participants
No intervention
Healthy Control Participants
No intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST)
Tidsramme: 2 hours after beginning of Time B Appointment
Participants are required to give a speech and an arithmetic test in front of a panel. Saliva samples are collected at 8 points throughout the test.
2 hours after beginning of Time B Appointment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mood and Anxiety Symptom Questionnaire (MASQ)
Tidsramme: Administered at first baseline appointment and covers past 2 weeks
Self-report scale of general distress (GD), anhedonic depression (AD), and anxious arousal (AA) symptoms
Administered at first baseline appointment and covers past 2 weeks
Reward Responsivity: Probabilistic Reward Task
Tidsramme: Administered at second baseline appointment
Computerized task that requires participants to choose between two stimuli and develop a response bias to the more frequently rewarded stimulus.
Administered at second baseline appointment
Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)
Tidsramme: Administered at first baseline appointment and covers past 2 weeks prior to interview
Self-report of anhedonia symptoms
Administered at first baseline appointment and covers past 2 weeks prior to interview

Samarbejdspartnere og efterforskere

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

Sponsor

Dr. Kate Harkness

Samarbejdspartnere

University Health Network, Toronto
McGill University
University of Calgary
Harvard University

Efterforskere

  • Ledende efterforsker: Kate Harkness, PhD, Queens 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)

1. juli 2015

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Faktiske)

31. december 2018

Datoer for studieregistrering

Først indsendt

13. maj 2016

Først indsendt, der opfyldte QC-kriterier

13. juni 2016

Først opslået (Skøn)

14. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PSYC-154-14

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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 .

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