Completed PHASE3 INTERVENTIONAL 6-arm NCT01360866

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial) (Orion)

A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Interventions Duloxetine Escitalopram Fluoxetine OPC-34712 Paroxetine CR Sertraline Venlafaxine XR

Updated 10 times since 2017 Last updated: Sep 14, 2018 Started: Oct 31, 2011 Primary completion: Apr 18, 2017 Completion: May 18, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Depression and Depressive Disorder and is currently completed. Otsuka Pharmaceutical Development & Commercialization, Inc. leads this study, which shows 10 recorded versions since 2011 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

Change History

10 versions recorded

Dec 2025 — Present [monthly]

Completed PHASE3
Sep 2025 — Dec 2025 [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 5 earlier versions

Oct 2018 — Jan 2021 [monthly]

Completed PHASE3
Jun 2018 — Oct 2018 [monthly]

Completed PHASE3
Dec 2017 — Jun 2018 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Feb 2017 — Dec 2017 [monthly]

Active Not Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE3

First recorded

Oct 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Achim, Germany , Allentown, United States , Alpharetta, United States , Arcachon, France , Arkhangelsk Region, Russia , Arlington, United States , Atlanta, United States , Austin, United States , Bala-Cynwyd, United States , Baltimore, United States and 132 more locations