- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00749125
fMRI Studies of Emotional Brain Circuitry in People With Major Depression
fMRI Studies of Emotional Circuitry in Major Depression
Aperçu de l'étude
Description détaillée
Major depressive disorder can be a recurrent problem for many people, interfering with their ability to function normally in day-to-day life. Although research shows that activation in certain brain areas corresponds to certain emotional functions, it is not well known which specific changes in brain functioning are related to or caused by depression. A proposed theory holds that depression is related to abnormal regulation of emotions and thoughts. This study will focus particularly on a brain circuit involved in emotional regulation, which includes the amygdala, the affective division of the anterior cingulate (ACad), and dorsolateral prefrontal cortex (DLPFC). The amygdala detects critical emotional information, especially threats; the ACad judges relevance of motivational cues, detects conflict, and regulates emotional responses; and the DLPFC has a critical role in supporting a wide range of cognitive control functions. This study will compare brain scans from people with and without depression to attempt to clarify which changes in brain functioning are related to depression.
Participation in this study will last 8 weeks. All participants will undergo initial screening in a telephone interview, then a diagnostic interview and brief physical examination. After passing through screening, participants will schedule a functional magnetic resonance imaging (fMRI) scan. The fMRI scan, lasting approximately 2 hours, will take pictures of both brain structure and brain functioning during different tasks. Also at this visit but outside the fMRI scanner, participants will be asked to complete an additional 2 hours of tasks on a computer. Depressed participants will then be given Lexapro, an approved drug for the treatment of depression. Participants taking Lexapro will go to scheduled doctor's visits after 2, 4, and 6 weeks of treatment to assess health, effectiveness of the drug, and side effects. On the eighth week, all participants will again undergo fMRI scanning and computer testing. At both the initial and follow-up fMRI study visits, images of brain function and anatomy will be recorded, heart rate will be monitored, and anxiety and arousal will be measured in the computer tests.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Depressed:
Inclusion Criteria:
- Participant meets DSM-IV criteria for major depressive disorder
- Minimum score greater than 18 on Hamilton Depression Inventory
- Participant is right handed
- Participant speaks English
Exclusion Criteria:
- Significant limitations that would interfere with testing procedures, such as uncorrected visual or hearing loss
- MRI contraindications, such as foreign metallic implants or a pacemaker
- Known primary neurological disorders, including dementia, stroke, encephalopathy, Parkinson's disease, brain tumors, multiple sclerosis, or seizure disorder
- Severe or unstable medical illness, such as a heart attack within the past 3 months, end stage cancer, or conditions or drugs that may cause depression (like systemic steroids or uncorrected hypothyroidism)
- Currently at risk for suicide
- Known allergy or hypersensitivity to escitalopram
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 1 Lexapro
The depressed participants in this arm will be given Lexapro.
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10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day
Autres noms:
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Aucune intervention: 2 Control
The nondepressed participants in this arm will not be given any intervention for depression.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Activations in Different Cortical Regions Caused by Emotionally Evocative Task
Délai: baseline and week 8
|
MRI scans from 41 participants (23 depressed and 18 controls), including fMRI scans using an emotional distractor task, were analyzed for differences between groups in activation in a priori regions (amygdala and DLPFC), measured with BOLD signal, for two conditions of the task - attend fearful and ignore fearful, both at baseline and following 8 weeks of treatment for the depressed group.
Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions.
Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region.
We expect more positive values (greater activation) in depressed participants at baseline than in controls during the attend fearful task, and more negative values (greater de-activation) in controls at baseline than depressed during the ignore fearful task.
These differences were expected to lessen significantly following treatment in the depressed group.
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baseline and week 8
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Yvette I. Sheline, MD, University of Pennsylvania
Publications et liens utiles
Publications générales
- Sheline YI, Price JL, Yan Z, Mintun MA. Resting-state functional MRI in depression unmasks increased connectivity between networks via the dorsal nexus. Proc Natl Acad Sci U S A. 2010 Jun 15;107(24):11020-5. doi: 10.1073/pnas.1000446107. Epub 2010 Jun 1.
- Sheline YI. Neuroimaging studies of mood disorder effects on the brain. Biol Psychiatry. 2003 Aug 1;54(3):338-52. doi: 10.1016/s0006-3223(03)00347-0.
- Fales CL, Barch DM, Rundle MM, Mintun MA, Mathews J, Snyder AZ, Sheline YI. Antidepressant treatment normalizes hypoactivity in dorsolateral prefrontal cortex during emotional interference processing in major depression. J Affect Disord. 2009 Jan;112(1-3):206-11. doi: 10.1016/j.jad.2008.04.027. Epub 2008 Jun 17.
- Sheline YI, Barch DM, Donnelly JM, Ollinger JM, Snyder AZ, Mintun MA. Increased amygdala response to masked emotional faces in depressed subjects resolves with antidepressant treatment: an fMRI study. Biol Psychiatry. 2001 Nov 1;50(9):651-8. doi: 10.1016/s0006-3223(01)01263-x.
- Fales CL, Barch DM, Rundle MM, Mintun MA, Snyder AZ, Cohen JD, Mathews J, Sheline YI. Altered emotional interference processing in affective and cognitive-control brain circuitry in major depression. Biol Psychiatry. 2008 Feb 15;63(4):377-84. doi: 10.1016/j.biopsych.2007.06.012. Epub 2007 Aug 24.
- Sheline YI, Barch DM, Price JL, Rundle MM, Vaishnavi SN, Snyder AZ, Mintun MA, Wang S, Coalson RS, Raichle ME. The default mode network and self-referential processes in depression. Proc Natl Acad Sci U S A. 2009 Feb 10;106(6):1942-7. doi: 10.1073/pnas.0812686106. Epub 2009 Jan 26.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Symptômes comportementaux
- Les troubles mentaux
- Troubles de l'humeur
- La dépression
- Dépression
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Médicaments psychotropes
- Inhibiteurs de l'absorption de la sérotonine
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Agents de sérotonine
- Agents antidépresseurs
- Agents antidépresseurs, deuxième génération
- Citalopram
Autres numéros d'identification d'étude
- R01MH064821-04 (Subvention/contrat des NIH des États-Unis)
- R01MH064821 (Subvention/contrat des NIH des États-Unis)
- 5R01 MH06482104
- DATR A3-NSM
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Lexapro
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Shanghai Mental Health CenterPas encore de recrutement
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St. Luke's-Roosevelt Hospital CenterForest LaboratoriesComplété
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Florida Gulf Coast UniversityComplétéTrouble dépressif majeurÉtats-Unis
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Massachusetts General HospitalNational Alliance for Research on Schizophrenia and DepressionComplétéDépendance à l'alcool | Trouble dépressif majeur | L'abus d'alcoolÉtats-Unis
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JHSPH Center for Clinical TrialsNational Institute on Aging (NIA)Actif, ne recrute pas
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Emory UniversityNational Institute of Mental Health (NIMH)Complété
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University of California, Los AngelesNational Institute of Mental Health (NIMH)Complété
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University of Texas Southwestern Medical CenterComplétéAsthme | Trouble dépressif majeurÉtats-Unis