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NCT05593029 · ClinicalTrials.gov registry record · Phase 2

A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

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

Completed
Registry status
Phase 2
Development phase
929
Enrollment target

NCT05593029 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 929 participants.

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The verdict

NCT05593029, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 2
Development phase
929 participants
Enrollment target

Study Summary

Demonstrate ability of SEP-363856 to be superior to placebo as an adjunctive therapy to ADT in change from baseline in depressive symptoms (MADRS \& CGI-S) in MDD patients who had an inadequate response to prior ADT therapy.

Interventions

  • OTHER Placebo
  • DRUG SEP-363856

Trial Details

FieldValue
Enrollment Target 929 participants
Start Date 2022-11-09
Est. Completion 2025-11-13
Phase Phase 2

What the Registry Record Tells You About NCT05593029

The ClinicalTrials.gov registry entry for NCT05593029 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 929 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

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

NCT05593029 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05593029 about?

NCT05593029 is a clinical study titled "A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder". Demonstrate ability of SEP-363856 to be superior to placebo as an adjunctive therapy to ADT in change from baseline in depressive symptoms (MADRS \& CGI-S) in MDD patients who had an inadequate response to prior ADT therapy.

What is the current status of trial NCT05593029?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 929 participants. The study started on 2022-11-09. Estimated completion is 2025-11-13.

What interventions are being tested in trial NCT05593029?

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

Who is sponsoring clinical trial NCT05593029?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.