- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00864630
Neuroimaging for Depression
23 mai 2011 mis à jour par: Massachusetts General Hospital
Objective Detection, Evaluation and Countermeasures for In-flight Depression
The investigators seek to determine whether brain imaging techniques can be used to help detect depression, assess its severity, and/or monitor or predict responses to treatment.
Subjects with minor or major depression will be randomly assigned to a wait-list control group or to treatment with a new computer-based cognitive behavior therapy developed by Dr. James Cartriene.
Brain imaging will be performed before and during treatment using both magnetic resonance imaging (MRI) and near-infrared spectroscopy (NIRS).
The investigators hypothesize that brain activity, particularly in the lateral frontal areas of the brain, will provide biomarkers for depression, depression severity, and treatment response.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
Depression can significantly disrupt one's ability to function effectively and efficiently, and the associated performance deficits can seriously jeopardize space mission success.
The incidence of serious depression in Earth based analogues of the spaceflight environment has been reported as up to 13% per person per year.
Extrapolating from existing reports of depressive episodes during short-duration spaceflight, depression is thus a probable condition in one or more members of a five to seven person crew during a long duration spaceflight (e.g., a 30 month mission to Mars).
Mission success can be jeopardized by depression either directly, from the potentially life threatening consequences of lapses in performance, or indirectly, by adding to the workload and stress of other crewmembers.
The likelihood and potentially serious consequences of depression during spaceflight explains why the risk of human performance failure due to mood alterations such as depression, anxiety, or other psychiatric and cognitive problems is a Priority 1 risk for all mission types (International Space Station, Moon, Mars).
Certain countermeasures are already in place: medications and psychological consultations with ground-crews.
However, current in-flight methods to decide whether a countermeasure should be used rely heavily on subjective self-reports.
The biological basis of mood disorders suggests neural biomarkers may provide a more objective method for assessing depression.
Aim 1 of this proposal, therefore, seeks to identify neural biomarkers sensitive to, and specific for, depression.
These measures will be used in evaluating and validating a flight-capable, noninvasive neuroimaging technology (near-infrared spectroscopy and imaging, or NIRS imaging) for its ability to detect biomarkers of depression and its severity.
As an initial step towards developing novel select-out criteria, Aim 2 will then evaluate which neural biomarkers appear most promising in detecting an endophenotype that identifies individuals at heightened risk for treatment resistance.
Finally, when depression is objectively identified, an appropriate countermeasure needs to be selected.
Aim 3 will focus on the ability of brain imaging to help predict the efficacy of Dr. Cartriene's computer based problem solving therapy.
Type d'étude
Interventionnel
Inscription (Anticipé)
68
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Massachusetts
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Charlestown, Massachusetts, États-Unis, 02129
- Massachusetts General Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
30 ans à 60 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- DSM-IV criteria for minor or major depression
- Written informed consent
- Age 30-60 years (age of individuals currently in the astronaut corps)
Exclusion Criteria:
- Suicidal or homicidal ideation
- Women who are pregnant, breastfeeding, or women of childbearing potential who are not using a medically accepted means of contraception
- Known history of serious or unstable medical illness
- History of seizure disorder, brain injury, any history of known neurological disease
- Clinical or lab evidence of untreated hypothyroidism
- History or DSM-IV diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance use disorders (excluding alcohol and nicotine) active within the last 12 months
- Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants
- Patients who have failed to respond during the course of their current major depressive episode to at least two antidepressant trials
- Currently undergoing depression-focused psychotherapy
- Patients who have taken an investigational psychotropic drug within the past year
- Patient cannot safely enter the MRI scanning environment
- Latex allergy
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Liste d'attente
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Expérimental: Computer-based problem solving therapy
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Computer program developed by Dr. James Cartriene at Beth Israel Deaconess Hospital, Boston, MA.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Functional magnetic resonance imaging
Délai: Pre-therapy and 4 weeks after therapy initiation
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Pre-therapy and 4 weeks after therapy initiation
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Functional near infrared neuroimaging
Délai: Pre-therapy and 2 and 4 weeks after therapy initiation
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Pre-therapy and 2 and 4 weeks after therapy initiation
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MRI-based brain perfusion
Délai: Pre-therapy and 4 weeks after therapy initiation
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Pre-therapy and 4 weeks after therapy initiation
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MRI-based brain morphology
Délai: Pre-therapy and 4 weeks after therapy initiation
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Pre-therapy and 4 weeks after therapy initiation
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MRI-based diffusion imaging
Délai: Pre-therapy and 4 weeks after therapy initiation
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Pre-therapy and 4 weeks after therapy initiation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Gary E Strangman, PhD, Massachusetts General Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2010
Achèvement primaire (Anticipé)
1 octobre 2011
Achèvement de l'étude (Anticipé)
1 décembre 2011
Dates d'inscription aux études
Première soumission
17 mars 2009
Première soumission répondant aux critères de contrôle qualité
18 mars 2009
Première publication (Estimation)
19 mars 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
24 mai 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 mai 2011
Dernière vérification
1 mai 2011
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NSBRI-NBFP01301
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 .