Longitudinal Assessment of Biomarkers Among Patients With MDD
This prospective observational study will evaluate whether speech collected through a smartphone application can be used to assess depressive symptom severity and detect symptom changes among adults with major depressive disorder receiving ketamine, esketamine, or infliximab.
Up to 100 participants will complete brief speech tasks and self-report measures of depression, anxiety, and insomnia at baseline, week 2, and week 4. Clinician-rated depression severity will be assessed at baseline and week 4.
Optional passive smartphone data, including activity and sleep measures, may also be collected. The study will examine the agreement between speech-based model predictions and established clinical assessments, as well as the ability of the model to identify symptom severity and treatment response. The study is observational and will not alter participants' clinical treatment. By evaluating remote speech-based assessments alongside optional passive behavioral monitoring, this research may support more effective measurement-based care and improve the evaluation and management of depression in clinical settings.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In this observational study, adults with Major Depressive Disorder (MDD) receiving ketamine, esketamine, or infliximab will be followed for up to 4 weeks. Data collection will include smartphone-based speech assessments, clinician-rated assessments of depression, self-report measures of depression, anxiety, and insomnia, and optional passive monitoring of sleep and activity patterns through a mobile application. The study will use machine learning and statistical methods to analyze speech-derived and behavioral data and to develop and evaluate digital biomarkers for assessing depression severity, tracking changes in symptoms over time, and predicting treatment response.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Paola Pedrelli, Ph.D.
- Numéro de téléphone: 617-724-2936
- E-mail: ppedrelli@mgh.harvard.edu
Sauvegarde des contacts de l'étude
- Nom: Erik Gee, B.A.
- Numéro de téléphone: 857-238-1301
- E-mail: egee2@mgh.harvard.edu
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Depression Clinical Research Program
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Contact:
- Paola Pedrelli, Ph.D.
- Numéro de téléphone: 617-724-2936
- E-mail: ppedrelli@mgh.harvard.edu
-
Contact:
- Erik Gee
- Numéro de téléphone: 857-238-1301
- E-mail: egee2@mgh.harvard.edu
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Chercheur principal:
- Paola Pedrelli, Ph.D.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Participants will be individuals with Major Depressive Disorder receiving ketamine, esketamine, or TNF inhibitor treatment.
La description
Inclusion Criteria:
- Clinical diagnosis of MDD confirmed via chart review
- Aged 18 years or older
- Fluent in reading and speaking English
- Capable of providing informed consent and complying with the protocol in the estimation of the investigator.
- Capable of operating the Callyope app
- Capable of completing speech tasks
- Owning a smartphone
Exclusion Criteria:
- Meeting DSM-5 criteria for any psychotic disorder (e.g., schizophrenia or delusional disorder) or a substance use disorder (excluding mild alcohol and cannabis use disorder, which will be permitted).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Montgomery Åsberg Depression Rating Scale (MADRS)
Délai: From baseline to Week 4
|
The MADRS is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. Total score can range from 0 to 60. |
From baseline to Week 4
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
Délai: At baseline, Week 2, and Week 4
|
The GAD-7 is a self-report questionnaire that assesses anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
At baseline, Week 2, and Week 4
|
|
Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Délai: At baseline, Week 2, and Week 4
|
The QIDS-SR16 is a self-report questionnaire that assesses depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. |
At baseline, Week 2, and Week 4
|
|
Insomnia Severity Index (ISI)
Délai: At baseline, Week 2, and Week 4
|
The ISI is a self-report questionnaire that assesses the severity of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating more severe insomnia symptoms. |
At baseline, Week 2, and Week 4
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026P001050
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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