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Neural Correlates of Stress and Perceived Control in Adolescent Depression

21 april 2022 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

80

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

Studieorter

    • Massachusetts
      • Belmont, Massachusetts, Förenta staterna, 02478
        • Rekrytering
        • Mclean Hospital
        • Kontakt:
        • Huvudutredare:
          • Emily L Belleau, PhD

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

14 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Computer Task Manipulation
Participants will complete computer tasks while undergoing an fMRI brain scan
Participants will complete computer tasks.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cortisol Rating
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

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

Sponsor

Utredare

  • Huvudutredare: Emily L Belleau, PhD, Mclean Hospital

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 (Faktisk)

23 april 2021

Primärt slutförande (Förväntat)

30 april 2025

Avslutad studie (Förväntat)

30 april 2025

Studieregistreringsdatum

Först inskickad

3 mars 2021

Först inskickad som uppfyllde QC-kriterierna

8 mars 2021

Första postat (Faktisk)

9 mars 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Major depressiv sjukdom

Kliniska prövningar på Computer Task Manipulation

3
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