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NCT05729373 · ClinicalTrials.gov registry record · Phase 2

A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 2
Development phase
434
Enrollment target

NCT05729373: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT05729373 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 434 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (226% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05729373, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 2
Development phase
434 participants
Enrollment target

Study Summary

A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.

Primary Outcome

The HAM-A scale consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point (0-4) scale, with higher scores indicating greater severity.

Interventions

  • DRUG Placebo
  • DRUG SEP-363856

Trial Details

FieldValue
Enrollment Target 434 participants
Start Date 2023-03-08
Est. Completion 2025-09-26
Phase Phase 2

What the finished NCT05729373 record still lists

NCT05729373 is an interventional study that assigns participants to a tested intervention. The registered 434 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (226% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05729373 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05729373 about?

NCT05729373 is a clinical study titled "A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder". A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and ap...

What is the current status of trial NCT05729373?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 434 participants. The study started on 2023-03-08. Estimated completion is 2025-09-26.

What interventions are being tested in trial NCT05729373?

The interventions under investigation include: Placebo (DRUG), SEP-363856 (DRUG).

Who is sponsoring clinical trial NCT05729373?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05729373's enrollment target sits among peer trials

434 90th of 2000 higher than 1,911 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05729373, the US trial registry maintained by the National Library of Medicine. NCT05729373 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.