- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04788524
Neural Correlates of Stress and Perceived Control in Adolescent Depression
Studieöversikt
Status
Betingelser
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
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Emily L Belleau, PhD
- Telefonnummer: 6178554245
- E-post: ebelleau@mclean.harvard.edu
Studieorter
-
-
Massachusetts
-
Belmont, Massachusetts, Förenta staterna, 02478
- Rekrytering
- Mclean Hospital
-
Kontakt:
- Emily L Belleau, PhD
- Telefonnummer: 617-855-4245
- E-post: ebelleau@mclean.harvard.edu
-
Huvudutredare:
- Emily L Belleau, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Inclusion Criteria: All Participants
- Females of all ethnic origins See Section: Inclusion of Women and Minorities);
- Ages 14-18 (See Section: Inclusion of Children);
- Written informed assent/consent from adolescent and parent/guardian (if under age 18);
- English as a first language or English fluency;
- Right handed111;
- 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
- Meet Diagnostic Statistical Manual-5th edition (DSM-5) diagnostic criteria for major depressive disorder (as diagnosed with the KSADS)
- 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
- No history or current diagnosis of any DSM-5 psychiatric or substance/alcohol-related disorder (as diagnosed with the KSADS)
- No first-degree relatives with a history of depression, bipolar disorder, or psychosis
Exclusion Criteria:
Exclusion Criteria: All Participants
- History of head trauma with loss of consciousness;
- History of seizure disorder;
- Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
- History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine);
- History of use of dopaminergic drugs (including methylphenidate);
- Use of hormonal replacement therapy, anabolic steroids, or hormonal contraception;
- Clinical or laboratory evidence of hypothyroidism;
- Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow;
- 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);
- Pregnancy
- 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;
- History of electroconvulsive therapy
- 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
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
Sponsor
Utredare
- Huvudutredare: Emily L Belleau, PhD, Mclean Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- K23MH122668 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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
-
Assistance Publique - Hôpitaux de ParisAvslutadMaj-Hemalin | Fechtners syndrom (störning) | Epsteins syndrom (störning) | MYH9-relaterade sjukdomarFrankrike
-
University Medical Center GoettingenAvslutadMajor depressiv sjukdom | Depressiv episodTyskland
-
York UniversityCentre for Addiction and Mental HealthUpphängdStörning, major depressivKanada
-
Wyeth is now a wholly owned subsidiary of PfizerAvslutadDepressiv sjukdom, allvarlig depressiv sjukdomFörenta staterna
-
Shalvata Mental Health CenterOkändSTOR depressiv sjukdomIsrael
-
Omni C&SAnmälan via inbjudanDepressiv sjukdom | Major depressiv sjukdom | Depressiv episodKorea, Republiken av
-
Seasons Biotechnology (Taizhou) Co., Ltd.AvslutadMajor depressiv sjukdom (MDD)Indien
-
Repurposed Therapeutics, Inc.Okänd
-
GlaxoSmithKlineAvslutadMajor depressiv sjukdom (MDD)Förenta staterna
-
University of WarsawHar inte rekryterat ännuMåttlig depressiv episod | Mild depressiv episod
Kliniska prövningar på Computer Task Manipulation
-
University of AmericasAktiv, inte rekryterandeBräcklighet | Funktionell rörelsestörningChile
-
KU LeuvenAktiv, inte rekryterande
-
Mayo ClinicAvslutad
-
Medical University of ViennaMedical University of GrazHar inte rekryterat ännuHjärteffekt | Hemodynamisk mätning | Icke-invasivÖsterrike
-
Chang Gung UniversityAvslutad
-
University of Texas at AustinRekryteringTrauma | Posttraumatisk stressyndromFörenta staterna
-
KU LeuvenAvslutadParkinsons sjukdom | Medicinsk överensstämmelse | Smartphone | Tryck på UppgiftBelgien
-
Huazhong University of Science and TechnologyFudan University; Second Affiliated Hospital of Zhengzhou University; Renmin... och andra samarbetspartnersAvslutad
-
Grant SandersAvslutadSubluxation av ländryggsleden