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Depressed for Depression

N/A
Waitlist Available
Research Sponsored by Kintsugi Mindful Wellness, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group

Summary

A prospective, single arm, non-randomized, pilot clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-CT) for up to 500 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5
Secondary study objectives
PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5
Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9
Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DepressedExperimental Treatment1 Intervention
All study participants will undergo the same study procedures. All individuals will complete brief online assessments about their emotional and physical wellbeing, provide audio recorded voice responses to prompts, and complete the SCID-5-CT with a clinician licensed in their state of residence while being audio and video recorded for quality assurance purposes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kintsugi Voice Device
2022
N/A
~140

Find a Location

Who is running the clinical trial?

Kintsugi Mindful Wellness, Inc.Lead Sponsor
4 Previous Clinical Trials
19,782 Total Patients Enrolled
3 Trials studying Depression
19,762 Patients Enrolled for Depression
Vituity PsychiatryUNKNOWN
Sonar StrategiesUNKNOWN
~167 spots leftby Mar 2025
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