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NCT05554042
Kintsugi Voice Device Study
trial testing Kintsugi Voice Device in Depression, Anxiety in 132 participants. Completed in 5 July 2023.
5 July 2023
Quick facts
| Lead sponsor | Kintsugi Mindful Wellness, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 132 |
| Start date | 23 September 2022 |
| Primary completion | 5 July 2023 |
| Estimated completion | 5 July 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Kintsugi Voice Device
Conditions studied
- Depression, Anxiety — all drugs for Depression, Anxiety →
Sponsor
Kintsugi Mindful Wellness, Inc.
Who can join
22 and older, any sex, with Depression, Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID) with a trained psychiatrist. This study seeks to evaluate the ability of the Device to aid clinical assessment for depression and anxiety by comparing its output with the established diagnostic standard consisting of a diagnosis made by a specialist clinician based on DSM-5 criteria. The order of the assessments will be randomized. Audio captured during the SCID interview will be inputted into a machine learning model to determine the diagnostic accuracy of the Kintsugi Voice Device.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05554042
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Kintsugi Voice Device
Trials testing the same drug.
- NCT06374056 — Kintsugi Voice Device Pilot Study · active not recruiting
Other recruiting trials for Depression, Anxiety
Currently open trials in the same condition.
- NCT07278466 — The COMParing App Support Strategies Study · NA · recruiting
- NCT07280481 — Weekly Dynamics of Psychopathological and Symptom Networks During Mindfulness-Based Interventions for Emotional Distress · NA · recruiting
- NCT07014852 — Integrating Inuit Knowledge Principles in Multi-Level Mental Health Clinical Trials · EARLY_PHASE1 · recruiting
- NCT07186816 — SUpport From PEeRs to Expand Access Study - Community · NA · recruiting
- NCT07091032 — Building Connections · NA · recruiting
Other Kintsugi Mindful Wellness, Inc. trials
Trials by the same sponsor.
- NCT06374056 — Kintsugi Voice Device Pilot Study · active not recruiting
- NCT04510519 — Scaling Mental Healthcare in COVID-19 With Voice Biomarkers · completed
- NCT05455905 — Voice Biomarkers Predictive of Depression and Anxiety · completed
- NCT04874077 — Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05554042 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kintsugi Mindful Wellness, Inc.
- Last refreshed: 12 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05554042.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing