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Neural Correlates of Stress and Perceived Control in Adolescent Depression

21. april 2022 oppdatert av: Emily L. Belleau, Mclean Hospital
Lack of perceived control, particularly during stress, has been critically implicated in major depressive disorder (MDD) and anhedonic symptoms, especially among female adolescents; yet the neural underpinnings of perceived control disruptions in MDD remain poorly understood. Using functional magnetic resonance imaging with a novel "value of control task" in conjunction with a prospective design, this study will provide a comprehensive understanding of stress and perceived control related mechanisms in female adolescents with MDD and will examine stress-induced disruptions in perceived control as a predictor of "real world" expressions of maladaptive coping and anhedonia.

Studieoversikt

Status

Rekruttering

Detaljert beskrivelse

Participants in this research will include 40 female adolescents, aged 14-18, with Major Depressive Disorder (MDD) and 40 healthy adolescents from the greater Boston area by Dr. Emily Belleau, at McLean Hospital's Center for Depression, Anxiety and Stress Research.

The study will include four sessions:

  • A clinical diagnostic interview as well as filling out a series of questionnaires and assessments.
  • The second session will include a functional magnetic resonance imaging (fMRI) brain scan to be conducted at the McLean Hospital Imaging Center. Participants will be asked to respond to surveys on their cell phone in the week following the fMRI brain scan.
  • The third session will include a diagnostic interview, assessments, and questionnaires to be completed three-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the week following this three month follow-up session.
  • The fourth session will include a diagnostic interview, assessments, and questionnaires to be completed six-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the week following this six month follow-up session.

Studietype

Intervensjonell

Registrering (Forventet)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Massachusetts
      • Belmont, Massachusetts, Forente stater, 02478
        • Rekruttering
        • McLean Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Emily L Belleau, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Inclusion Criteria: All Participants

    1. Females of all ethnic origins See Section: Inclusion of Women and Minorities);
    2. Ages 14-18 (See Section: Inclusion of Children);
    3. Written informed assent/consent from adolescent and parent/guardian (if under age 18);
    4. English as a first language or English fluency;
    5. Right handed111;
    6. Personal cell-phone (for Ecological Momentary Assessment [EMA]) 7 All participants will be in the follicular phase of their menstrual cycle when completing the functional magnetic resonance imaging (fMRI) study session

Inclusion Criteria: MDD Sample

  1. Meet Diagnostic Statistical Manual-5th edition (DSM-5) diagnostic criteria for major depressive disorder (as diagnosed with the KSADS)
  2. Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants);

Inclusion Criteria: Healthy Control (HC) Sample

  1. No history or current diagnosis of any DSM-5 psychiatric or substance/alcohol-related disorder (as diagnosed with the KSADS)
  2. No first-degree relatives with a history of depression, bipolar disorder, or psychosis

Exclusion Criteria:

  • Exclusion Criteria: All Participants

    1. History of head trauma with loss of consciousness;
    2. History of seizure disorder;
    3. Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
    4. History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine);
    5. History of use of dopaminergic drugs (including methylphenidate);
    6. Use of hormonal replacement therapy, anabolic steroids, or hormonal contraception;
    7. Clinical or laboratory evidence of hypothyroidism;
    8. Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow;
    9. Failure to meet standard exclusion criteria for fMRI scanning (e.g., claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other metal objects in the body);
    10. Pregnancy
    11. Testing positive on a drug test on the day of the scan which testis for stimulants, marijuana, barbiturates, benzodiazepine, buprenorphine, 3,4-Methyl enedioxy methamphetamine (MDMA), methadone, opiates, oxycodone, phencyclidine;
    12. History of electroconvulsive therapy
    13. Participants with suicidal ideation where study participation is deemed unsafe by the study clinician;

Additional Exclusion Criteria: Major Depressive Disorder (MDD) Sample

1. Major depressive disorder diagnosis secondary to another disorder (selected comorbid anxiety disorders such as generalized anxiety disorder, specific phobia, and social anxiety disorders are allowed if they are secondary to MDD)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Computer Task Manipulation
Participants will complete computer tasks while undergoing an fMRI brain scan
Participants will complete computer tasks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex
Tidsramme: 1.5 hour long scan during session 2
BOLD activation of frontostriatal regions in response to computer tasks performed during the fMRI Brian scan
1.5 hour long scan during session 2

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cortisol Rating
Tidsramme: collected as part of 1.5 hour long scan during session 2
Saliva rating to be collected throughout the fMRI brain scan
collected as part of 1.5 hour long scan during session 2
Mood Rating
Tidsramme: collected as part of 1.5 hour long scan during session 2
Self-reported mood rating to be collected throughout the fMRI brain scan
collected as part of 1.5 hour long scan during session 2
Stress Reactivity Score
Tidsramme: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Stress Reactivity Survey Item collected via smart-phone delivered ecological momentary assessment
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Stress Reactive Rumination Score
Tidsramme: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Stress Reactive Rumination Scale collected via smart-phone delivered ecological momentary assessment
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Positive Affect Score
Tidsramme: Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
Positive Affect Survey Items collected via smart-phone delivered ecological momentary assessment
Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: Emily L Belleau, PhD, McLean Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. april 2021

Primær fullføring (Forventet)

30. april 2025

Studiet fullført (Forventet)

30. april 2025

Datoer for studieregistrering

Først innsendt

3. mars 2021

Først innsendt som oppfylte QC-kriteriene

8. mars 2021

Først lagt ut (Faktiske)

9. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • K23MH122668 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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