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Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders

31. januar 2020 opdateret af: University of Minnesota
This study consists of three separate appointments including a clinical assessment (interview and questionnaires), a blood draw, a social stress test, and a brain MRI.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a research study looking at the biology of mood disorders in youth. The investigator ask participants to come in for three visits. The first visit includes a diagnostic interview, some questionnaires, and a blood draw. The blood draw will take place at the Fairview Outpatient Lab. A trained technician will take about 4 teaspoons of blood from the participant's arm. This sample will be sent to Dr. Andreazza in Toronto, Ontario for further analysis. No results will be shared with the participant.

The second visit would take place at the Fairview Riverside Ambulatory Research Center (ARC). This appointment will include the Trier Social Stress Test (TSST). For this, participants will be asked to prepare a short speech for 5 minutes and deliver that speech for in front of an audience with another task to follow. This task will be videotaped. After the participant has completed the speech task, the participant will be asked to complete a number of laptop games which will test for things like attention and memory. Participants will be asked to provide 5 saliva samples throughout the course of this visit so the investigators can look at Cortisol which is a hormone naturally found in saliva. The investigators will also ask participants to complete an additional set of 5 spit samples at home during the course of a normal day and bring those back to their next appointment.

The third visit would take place at the Center for Magnetic Resonance Research (CMRR) and would include a brain MRI. The MRI scan is noninvasive and takes about 2 hours. Participants will be asked to provide a urine sample and complete a urine toxicology screen (drug test) and pregnancy test (if female) prior to the MRI scan. Participants may not participate if drug or pregnancy testing is positive. The MRI involves taking pictures of the brain, from which measures of the integrity of certain brain tissues can be derived. For the scan, participants will be asked to lie down quietly on a scanner bed. Once they are inside the scanner, it will start to take pictures. While in the scanner, participants will be doing things like resting, or listening to music.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

54

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55454
        • Ambulatory Research Center (ARC)
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Center for Magnetic Resonance Research

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 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adolescents with mood disorders will be recruited from the University of Minnesota outpatient and inpatient clinical services, through physician referral, and through community postings. Recruitment of healthy controls will be done through flyers and online postings in the community.

Beskrivelse

Inclusion Criteria - All Participants:

  • Age 13-18 years old
  • Both child and guardian are English speaking

Inclusion Criteria - Patient Group:

  • Has a diagnosis of a depressive disorder, a bipolar spectrum disorder (type 1, type 2, Unspecified), or an unspecified mood disorder based on the Diagnostic Statsitical Manual 5 (DSM-5)

Inclusion Criteria - Healthy Controls

  • Does not meet criteria for any psychiatric disorders based on the DSM-5
  • Does not have a family history of psychotic or mood disorders in first degree relative

Exclusion Criteria:

  • Past history of brain damage, a seizure disorder, increased intracranial pressure, history of head trauma with loss of consciousness for >15 minutes, history of stroke, mental retardation, or other serious neurological disorder
  • MRI contraindications such as braces, metal implants, implanted medical devices, or claustrophobia
  • Intelligence quotient < 80
  • Severe or acute medical illness
  • A history of current (past 3 months) substance disorder (defined by DSM-5) with the exception of Nicotine
  • Refusal to cooperate with study procedures
  • Active suicidal ideation with intent
  • Self-injury that requires medical attention (e.g. stitches) or gets significantly worse during the course of the study

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
Adolescents with Mood Disorders
Teens aged 13-18 with a diagnosis of a mood disorder.
Adolescents with no Mental Health Diagnoses
13-18, no psychiatric d/o diagnosis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood Analysis
Tidsramme: Baseline
Blood samples will be analysed for mitochondrial dysfunction and resulting oxidative damage to lipids, and protein and messenger ribonucleic acid levels of inflammatory cytokines
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MRI Data
Tidsramme: Up to 6 weeks after baseline
White matter integrity. Diffusion imaging data will be processed, following registration and motion correction, using a probabilistic tractography approach that will define and extract parameters such as fractional anisotrophy and radial diffusion from fiber bundles of interest. In this study we will focus on white matter tracts connecting fronto-limbic brain regions. Details about the tractography procedures can be found at http://surfer.nmr.mgh.harvard.edu/fswiki/Tracula
Up to 6 weeks after baseline
Saliva Cortisol
Tidsramme: Up to 6 weeks of baseline
Stress Functioning. Saliva samples from the Trier Social Stress Test will be stored in a freezer and sent as a complete batch to Trier, Germany. We will conduct repeated measures ANOVA tests on the cortisol data and examine group and group x time interactions. We will calculate the Area Under the Curve for each person's pattern of cortisol responses over time, and these values will be used in multivariate regression analyses below.
Up to 6 weeks of baseline
Beck Depression Inventory (BDI-II)
Tidsramme: Baseline and within 6 weeks of baseline
Measures levels of depression in participants. Has information on suicidal ideation. If participants are suicidal, a member of research staff will talk with the participant and develop a safety plan with the adolescent and their parent.
Baseline and within 6 weeks of baseline
Children's Depression Rating Scale - Revised (CDRS-R)
Tidsramme: Baseline
Measures levels of depression in participants. Has information on suicidal ideation. If participants are suicidal, a member of research staff will talk with the participant and develop a safety plan with the adolescent and their parent.
Baseline

Samarbejdspartnere og efterforskere

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

Sponsor

University of Minnesota

Samarbejdspartnere

Ontario Mental Health Foundation

Efterforskere

  • Ledende efterforsker: Kathryn R Cullen, MD, University of Minnesota
  • Ledende efterforsker: Ana Andreazza, PhD, University of Toronto, Ontario
  • Ledende efterforsker: Bonnie Klimes-Dougan, PhD, University of Minnesota

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)

31. oktober 2015

Primær færdiggørelse (Faktiske)

31. marts 2018

Studieafslutning (Faktiske)

31. marts 2018

Datoer for studieregistrering

Først indsendt

13. oktober 2015

Først indsendt, der opfyldte QC-kriterier

3. november 2015

Først opslået (Skøn)

4. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1507M75201

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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