Pilot Trial of Mobile Technology for Adolescent Suicidality

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Oui Therapeutics, Inc.
Study ID
NCT06454136
Status
Enrolling By Invitation

Conditions

  • Suicidal Ideation

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • OTX-207 — DEVICE
    Experimental Pscyhoeducation and Intervention App
  • Comparator App + Treatment as Usual (TAU) — DEVICE
    Digitized content and information included in standard of care (i.e., TAU)

Study Details

The primary objective of this study is to assess the efficacy of a digital intervention in reducing suicidal ideation in adolescents.

Key Dates

Start date
Oct 23, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
  • Sham Comparator: Control

Primary Outcome Measure

Scale for Suicide Ideation (SSI) [ Time Frame: 12 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Hartford HealthCareHartfordConnecticut06106-
University of CincinnatiCincinnatiOhio45219-
Rhode Island/Bradley Hospital/Brown Health UniversityProvidenceRhode Island02903-

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