# A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic

> **NCT05144685** · PHASE2,PHASE3 · TERMINATED · sponsor: **Oui Therapeutics, Inc.** · enrollment: 356 (actual)

## Conditions studied

- Suicide, Attempted
- Suicidal Ideation

## Interventions

- **DEVICE:** OTX-202
- **DEVICE:** OTX-000
- **BEHAVIORAL:** Treatment as Usual

## Key facts

- **NCT ID:** NCT05144685
- **Lead sponsor:** Oui Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-04-07
- **Primary completion:** 2024-06-14
- **Final completion:** 2024-06-14
- **Target enrollment:** 356 (ACTUAL)
- **Why stopped:** Data Safety Monitoring Board (DSMB) recommendation per Charter stopping rules. The study surpassed the pre-planned futility boundary.
- **Last updated:** 2025-06-12

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05144685

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05144685, "A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT05144685. Licensed CC0.

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