Clinical TrialDepressive DisordersEsketamineEnrolling by invitation

Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions

This observational cohort study (n=200) will assess whether a speech-based machine learning algorithm can predict treatment response to psychiatric interventions, specifically repetitive transcranial magnetic stimulation (TMS) and Spravato (esketamine) nasal spray.

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Target Enrollment
200 participants
Study Type
Phase NA observational
Design
Non-randomized

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Compound research: EsketamineTopic research: Depressive DisordersResearch in United States

Detailed Description

This prospective observational cohort (n=200) will enrol outpatients aged 18–68 receiving TMS or Spravato (esketamine) as part of clinical care; speech recordings are collected before treatment, daily during treatment, immediately after treatment, and at 4‑week follow-up.

The primary aim is to train and validate a speech-based machine learning algorithm to predict treatment response, defined as a ≥2-point improvement on the Clinical Global Impression that is sustained through the 4‑week follow-up.

Participants complete ~12‑minute speech recordings responding to six prompts and standard clinical rating scales; the study will also monitor for any distress caused by the speech assessments.

Study Arms & Interventions

Esketamine

experimental

Participants prescribed and administered Spravato (esketamine) as part of usual care.

Interventions

  • Esketamine
    via Other• as prescribed

    Spravato (esketamine) administered per local clinical protocol; dosing variable

TMS

experimental

Participants prescribed and administered repetitive transcranial magnetic stimulation (rTMS) as part of usual care.

Interventions

  • Compound
    via Other• as prescribed

    rTMS sessions per local clinical protocol

Participants

Ages
18 – 68
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Outpatient status
  • 2. Men and women aged 18-68 years
  • 3. Capable and willing to provide informed consent
  • 4. Able to adhere to the treatment schedule
  • 5. Stable on medication for at least 2 months with no anticipated changes during the study period
  • 6. Diagnosis of MDD, PTSD, or BD
  • 7. Eligible for and scheduled to receive TMS or Spravato (esketamine) treatment to alleviate symptoms of MDD, PTSD, GAD, OCD or BD
  • 8. Fluent in English
  • 9. Access to a stable internet connection and an electronic device with a microphone for voice recording

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Use of any investigational drug within four weeks of the baseline visit
  • 2. If participating in psychotherapy, the patient must have been in stable treatment for at least three months before study entry, with no anticipated changes in the frequency of therapeutic sessions or therapeutic focus during the TMS or Spravato treatment.
  • 3. Intoxication during speech assessments
  • 4. Cognitive impairment that would interfere with study participation or data quality
  • 5. Lack of fluency in English

Study Protocol, Arms & Participants

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Study Details

  • Status
    Enrolling by invitation
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment200 participants
  • Timeline
    Start: 2025-02-18
    End: 2026-01-01
  • Compound
    Esketamine
  • Topic
    Depressive Disorders

Study Team

Sponsors & Collaborators

Locations

Acacia Clinics — Sunnyvale, California, United States
Fermata Health — New York, New York, United States

Recent activity

  • StartedAssess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychi… (NCT06823024, esketamine)

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