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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Paola Pedrelli, Ph.D.
- Telefonnummer: 617-724-2936
- E-post: ppedrelli@mgh.harvard.edu
Studera Kontakt Backup
- Namn: Erik Gee, B.A.
- Telefonnummer: 857-238-1301
- E-post: egee2@mgh.harvard.edu
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02114
- Rekrytering
- Depression Clinical Research Program
-
Kontakt:
- Paola Pedrelli, Ph.D.
- Telefonnummer: 617-724-2936
- E-post: ppedrelli@mgh.harvard.edu
-
Kontakt:
- Erik Gee
- Telefonnummer: 857-238-1301
- E-post: egee2@mgh.harvard.edu
-
Huvudutredare:
- Paola Pedrelli, Ph.D.
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Participants will be individuals with Major Depressive Disorder receiving ketamine, esketamine, or TNF inhibitor treatment.
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: OTHER
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Montgomery Åsberg Depression Rating Scale (MADRS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
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
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026P001050
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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