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Набор по приглашению NCT06823024

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

— Наблюдательное Obsessive Compulsive Disorder (OCD) Bipolar Disorders Major Depressive Disorder Post-Traumatic Stress Disorder, PTSD

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Obsessive Compulsive Disorder (OCD), Bipolar Disorders, Major Depressive Disorder, Post-Traumatic Stress Disorder, PTSD. Базовые параметры: 18 лет — 68 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

An Observational, Prospective Study to Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions

Обзор

This is a research study looking at whether the way people speak can help predict how well they'll respond to certain mental health treatments. The Main Goal: The researchers want to see if computer analysis of a person's speech patterns can predict whether they'll respond well to two specific treatments: TMS (Transcranial Magnetic Stimulation) and Spravato (a nasal spray medication). They're focusing on people with depression, bipolar disorder, OCD, anxiety, and PTSD. How It Works: 200 people with these conditions will participate in the study.Participants will record themselves speaking for about 12 minutes, responding to six different prompts.They'll do these recordings before treatment starts, daily during treatment, right after treatment ends, and again four weeks later. Doctors will track how well people are doing using various questionnaires and rating scales The researchers will look for connections between speech patterns and treatment success. The study will last 12 months. What Makes Someone a "Treatment Success": The study considers treatment successful if a person's symptoms improve significantly (specifically, a 2-point or greater reduction on a clinical rating scale (called Clinical Global Impression) and stays improved during the follow-up period (4-weeks). Why This Matters: If successful, this research could lead to a simple, non-invasive way to help doctors predict which treatments might work best for different patients. This could help people get the most effective treatment more quickly and help healthcare providers use their resources more efficiently. Safety Consideration The researchers will also check whether doing the speech assessments causes any distress to participants, making sure the evaluation process itself is safe and comfortable.

Первичные конечные точки

  • Treatment response [Срок оценки: Change between Baseline and Week 0 (post-intervention)]
Вторичные конечные точки (3)
  • Remission [Срок оценки: Change between Baseline and Week 0 (post-intervention), Week 4 (post-intervention)]
  • Stability of treatment response [Срок оценки: Change between Baseline and Week 4 (post-intervention)]
  • Distress caused by the online speech assessment [Срок оценки: Week 4]

Критерии участия

Критерии включения

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

Критерии исключения

  • Use of any investigational drug within four weeks of the baseline visit
  • 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.
  • Intoxication during speech assessments
  • Cognitive impairment that would interfere with study participation or data quality
  • Lack of fluency in English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • Acacia Clinics — Sunnyvale
  • Fermata Health — New York

Идентификаторы

NCT: NCT06823024 · PSYRIN-0005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗