Depressive DisorderPhase 3OrionNCT01360866

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

A Phase 3 study testing OPC-34712, Escitalopram and Fluoxetine in people with Depressive Disorder and Depression, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 142 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depressive Disorder, Depression, Depressive Disorder, Major
What is being tested?: OPC-34712, Escitalopram and Fluoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,944 participants
Where: 142 sitesin 11 countries
Study dates: Oct 2011to 18 May 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and Female outpatients 18-65 years of age
Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:
Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial
Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:
Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.

Who cannot join

Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.
Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase

Trial locations and contacts

142 sites in 11 countries.

Country

City, postcode or hospital

142 sites in 11 countries

United States93 sites

Research Site
Allentown, Pennsylvania
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Alpharetta, Georgia
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Arlington, Texas
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Atlanta, Georgia
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Austin, Texas
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Bala-Cynwyd, Pennsylvania
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Baltimore, Maryland
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Beachwood, Ohio
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Bellevue, Washington
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Belmont, Massachusetts
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Beverly Hills, California
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Birmingham, Alabama
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Boston, Massachusetts
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Bridgeville, Pennsylvania
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Brooklyn, New York
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Brown Deer, Wisconsin
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Charlottesville, Virginia
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Cherry Hill, New Jersey
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Cincinnati, Ohio
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Columbia, South Carolina
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Columbus, Ohio
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Coral Gables, Florida
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Coral Springs, Florida
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Costa Mesa, California
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Creve Coeur, Missouri
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Dallas, Texas
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Dayton, Ohio
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Decatur, Georgia
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Fort Myers, Florida
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Gainesville, Florida
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Glendale, California
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Herndon, Virginia
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Hialeah, Florida
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Houston, Texas
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Indianapolis, Indiana
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Irvine, California
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Jacksonville, Florida
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Jacksonville Beach, Florida
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Jamaica, New York
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Kirkland, Washington
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Lafayette, Indiana
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Lake Charles, Louisiana
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Las Vegas, Nevada
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Lincoln, Rhode Island
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Little Rock, Arkansas
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Melbourne, Florida
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Memphis, Tennessee
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Methuen, Massachusetts
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Miami, Florida
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Miami Springs, Florida
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Middleton, Wisconsin
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Murray, Utah
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New Orleans, Louisiana
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New York, New York
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Norristown, Pennsylvania
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Norwalk, Connecticut
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Oak Brook, Illinois
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Oakland Park, Florida
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Oceanside, California
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Oklahoma City, Oklahoma
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Orlando, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Portland, Oregon
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Prairie Village, Kansas
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Raleigh, North Carolina
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Redlands, California
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Richmond, Virginia
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Rochester, New York
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Rochester Hills, Michigan
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Salem, Oregon
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San Antonio, Texas
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San Diego, California
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San Francisco, California
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Santa Ana, California
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Seattle, Washington
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Sherman Oaks, California
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Shreveport, Louisiana
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Smyrna, Georgia
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Spokane, Washington
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Staten Island, New York
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Temecula, California
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The Villages, Florida
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Toledo, Ohio
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Tom River, New Jersey
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Upland, California
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Watertown, Massachusetts
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Weymouth, Massachusetts
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Wichita, Kansas
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Wichita Falls, Texas
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Wilmington, North Carolina
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Winter Park, Florida
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Woodstock, Vermont

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Poland9 sites

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Bełchatów
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Bydgoszcz
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Katowice
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Kielce
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Lublin
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Poznan
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Pruszcz Gdański
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Tuszyn
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Wroclaw

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Russia8 sites

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Moscow
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Saint Petersburg
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France7 sites

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Canada5 sites

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Serbia4 sites

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Ukraine4 sites

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Romania3 sites

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Slovakia3 sites

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Hungary1 site

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About this study

Official title: 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

Conditions: Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
Being tested: OPC-34712, Escitalopram, Fluoxetine, Paroxetine CR, Sertraline
Keywords: OPC-34712, brexpiprazole, Major Depressive Disorder, Adjunctive Treatment
Medical subject headings: Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-34712Drug
Tablet
EscitalopramDrug
Also called Lexapro
Tablet
FluoxetineDrug
Also called Prozac
Capsule
Paroxetine CRDrug
Also called Paxil CR
Controlled-release tablets
SertralineDrug
Also called Zoloft
Tablets
DuloxetineDrug
Also called Cymbalta
Delayed-release capsules
Venlafaxine XRDrug
Also called Effexor XR
Extended-release capsules

Study groups in NCT01360866
Study group	Role	What they receive
OPC-34712 (Brexpiprazole) and Escitalopram	Experimental	OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day Receives: Drug: OPC-34712; Drug: Escitalopram
OPC-34712 and Fluoxetine	Experimental	OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day Receives: Drug: OPC-34712; Drug: Fluoxetine
OPC-34712 and Paroxetine CR	Experimental	OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day Receives: Drug: OPC-34712; Drug: Paroxetine CR
OPC-34712 and Sertraline	Experimental	OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day Receives: Drug: OPC-34712; Drug: Sertraline
OPC-34712 and Duloxetine	Experimental	OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day Receives: Drug: OPC-34712; Drug: Duloxetine
OPC-34712 and Venlafaxine XR	Experimental	OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day Receives: Drug: OPC-34712; Drug: Venlafaxine XR

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Measured: From screening to week 52/early termination
Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.
Measured: From screening to week 52/early termination
Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely.
Scores of 5 and above were associated with significant functional impairment.
Measured: From screening to week 52/early termination
Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score
The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst).
Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.
Measured: From screening to week 52/early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201118 May 2017

First posted26 May 2011 (estimated)
Study startOct 2011
Primary completion18 Apr 2017
Study completion18 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,944 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01360866
Sponsor's protocol ID: 331-10-238
Acronym: Orion
Status last verified: Sep 2018
First submitted: 24 May 2011
Last updated: 17 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Newcomer JW, Meehan SR, Chen D, Brubaker M, Weiss C. 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. J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786.
PubMed 37656180
Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.
PubMed 31577867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01360866
Acronym / sponsor ID: Orion / 331-10-238
Conditions: Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
Keywords: OPC-34712, brexpiprazole, Major Depressive Disorder, Adjunctive Treatment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,944 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2011 (actual)
Primary completion: 18 Apr 2017 (actual)
Study completion: 18 May 2017 (actual)
First posted: 26 May 2011 (estimated)
Results: Posted 17 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
OPC-34712 (Brexpiprazole) and Escitalopram	Experimental	Drug: OPC-34712, Drug: EscitalopramOPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day
OPC-34712 and Fluoxetine	Experimental	Drug: OPC-34712, Drug: FluoxetineOPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day
OPC-34712 and Paroxetine CR	Experimental	Drug: OPC-34712, Drug: Paroxetine CROPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day
OPC-34712 and Sertraline	Experimental	Drug: OPC-34712, Drug: SertralineOPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day
OPC-34712 and Duloxetine	Experimental	Drug: OPC-34712, Drug: DuloxetineOPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day
OPC-34712 and Venlafaxine XR	Experimental	Drug: OPC-34712, Drug: Venlafaxine XROPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male and Female outpatients 18-65 years of age
Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial
Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.

Key exclusion criteria (2 listed)

Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.
Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-34712Tablet	Drug	OPC-34712 (Brexpiprazole) and Escitalopram, OPC-34712 and Duloxetine, OPC-34712 and Fluoxetine, OPC-34712 and Paroxetine CR, OPC-34712 and Sertraline, OPC-34712 and Venlafaxine XR
EscitalopramAlso: LexaproTablet	Drug	OPC-34712 (Brexpiprazole) and Escitalopram
FluoxetineAlso: ProzacCapsule	Drug	OPC-34712 and Fluoxetine
Paroxetine CRAlso: Paxil CRControlled-release tablets	Drug	OPC-34712 and Paroxetine CR
SertralineAlso: ZoloftTablets	Drug	OPC-34712 and Sertraline
DuloxetineAlso: CymbaltaDelayed-release capsules	Drug	OPC-34712 and Duloxetine
Venlafaxine XRAlso: Effexor XRExtended-release capsules	Drug	OPC-34712 and Venlafaxine XR

Primary outcome

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.

4 secondary outcomes

Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
Time frame: From screening to week 52/early termination
Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
Time frame: From screening to week 52/early termination
Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
Time frame: From screening to week 52/early termination
Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score
Time frame: From screening to week 52/early termination

Results and safety

Results posted to the registry on 17 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prior Placebo	516	295
Prior Brexpiprazole	707	420
Prior ADT	1,645	1,126
Prior Seroquel	76	54

Primary outcome: Adverse Events (AEs) - All Participants

Time frame: From screening to week 52/early termination. Count of participants. Unit: Participants

Measure	Prior Placebo n = 516	Prior Brexpiprazole n = 706	Prior ADT n = 1640	Prior Seroquel n = 76
Participants with adverse events	400	511	1165	51
Participants with treatment emergent AE (TEAE)	399	510	1163	51
Participants with serious TEAE	14	23	33	1
Participants with severe TEAE	48	64	99	4
Partcipants discontinued due to AEs	55	58	134	6

Population analysed: Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prior Placebo	14 of 516 (2.7%)	296 of 516 (57.4%)	2 of 516
Prior Brexpiprazole	23 of 706 (3.3%)	323 of 706 (45.8%)	2 of 706
Prior ADT	33 of 1,640 (2%)	787 of 1,640 (48%)	0 of 1,640
Prior Seroquel	1 of 76 (1.3%)	33 of 76 (43.4%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37656180Newcomer JW, Meehan SR, Chen D, Brubaker M, Weiss C. 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. J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786.
Derived from this study: PubMed 31577867Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

142 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Poland, Russia, France, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) - All Participants (time frame: From screening to week 52/early termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01360866, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.