NCT01360866 (Orion) is a Phase 3 clinical trial of OPC-34712 in Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who is sponsoring NCT01360866?

NCT01360866 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What drugs are being tested in NCT01360866?

Interventions in NCT01360866: OPC-34712, Escitalopram, Fluoxetine, Paroxetine CR, Sertraline, Duloxetine, Venlafaxine XR.

What condition does NCT01360866 study?

NCT01360866 studies Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders.

Is NCT01360866 still recruiting?

NCT01360866 is currently completed. Last updated 14 September 2018.

Are results published for NCT01360866?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-09-14 · How we verify

NCT01360866: Orion

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 14 September 2018

What this trial tests

Phase 3 trial testing OPC-34712 in Depressive Disorder in 2,944 participants. Completed in 18 May 2017.

Timeline

1 October 2011

Primary endpoint
18 April 2017

18 May 2017

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2,944
Start date	1 October 2011
Primary completion	18 April 2017
Estimated completion	18 May 2017
Sites	142 locations across United States, Canada, France, Germany, Hungary, Poland, Romania, Russia

Drugs / interventions tested

OPC-34712
Escitalopram (escitalopram) — full drug profile →
Fluoxetine (fluoxetine) — full drug profile →
Paroxetine CR
Sertraline (sertraline) — full drug profile →
Duloxetine (duloxetine) — full drug profile →
Venlafaxine XR

Conditions studied

Depressive Disorder — all drugs for Depressive Disorder →
Depression — all drugs for Depression →
Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
Mood Disorders — all drugs for Mood Disorders →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Depressive Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Adverse Events (AEs) - All Participants
Time frame: From screening to week 52/early termination
To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.

Sponsor's own description

To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder.
Hobart M, Zhang P, Skuban A, Brewer C, et al · · 2019 · cited 16× · PMID 30946704 · DOI 10.1097/jcp.0000000000001034
Effect of Brexpiprazole on Prolactin and Sexual Functioning: An Analysis of Short- and Long-Term Study Data in Major Depressive Disorder.
Clayton AH, Ivkovic J, Chen D, George V, et al · · 2020 · cited 9× · PMID 33136923 · DOI 10.1097/jcp.0000000000001297
Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies.
Newcomer JW, Eriksson H, Zhang P, Meehan SR, et al · · 2019 · cited 8× · PMID 31577867 · DOI 10.4088/jcp.18m12680
Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies.
Newcomer JW, Meehan SR, Chen D, Brubaker M, et al · · 2023 · cited 4× · PMID 37656180 · DOI 10.4088/jcp.23m14786
A Multicenter, Open-Label Study to Evaluate the Long-term Safety and Efficacy of Adjunctive Brexpiprazole 2 mg Daily in Japanese Patients with Major Depressive Disorder.
Kato M, Shiosakai M, Kuwahara K, Iba K, et al · · 2024 · cited 2× · PMID 39424742 · DOI 10.1007/s40263-024-01124-w
Assessment of minimum clinically important difference in symptoms and functionality of Japanese patients with major depressive disorder following inadequate response to antidepressants: a <i>post hoc</i> analysis of the long-term study of brexpiprazole augmentation th
Hori H, Shiosakai M, Shibasaki Y, Yamato K, et al · · 2025 · PMID 40206646 · DOI 10.3389/fpsyt.2025.1556470
PS155. Long-term safety of adjunctive brexpiprazole (OPC-34712) in MDD: results from two 52-week open-label studies
Nelson C, Skuban A, Zhang P, Weiller E, et al · · 2016

Verify or expand the search:

Other trials of OPC-34712

Trials testing the same drug.

NCT02875080 — Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects · Phase 1 · completed

Other recruiting trials for Depressive Disorder

Currently open trials in the same condition.

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NCT06901739 — Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity. · NA · recruiting
NCT06724666 — Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression · NA · recruiting

Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials

Trials by the same sponsor.

NCT07525960 — A Study in Adult Males With X-linked Congenital Nephrogenic Diabetes Insipidus to Test the Effects of NDI-5001 Given for · Phase 1 · not yet recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07455084 — A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults · Phase 1 · not yet recruiting
NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01360866 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 14 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01360866.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing