Trial · NCT01360866

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

NCT01360866, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2018-09-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial). Trials, record NCT01360866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01360866

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
NCT number: NCT01360866
Status: Completed
Phases: Phase 3
Enrollment: 2,944 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
Interventions: OPC-34712, Escitalopram, Fluoxetine, Paroxetine CR, Sertraline, Duloxetine, Venlafaxine XR
First posted: 2011-05-26
Last updated: 2018-09-17
Results first posted: 2018-09-17

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Adverse Events (AEs) - All Participants	From screening to week 52/early termination	To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.
Secondary	Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score	From screening to week 52/early termination	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.
Secondary	Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score	From screening to week 52/early termination	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.
Secondary	Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score	From screening to week 52/early termination	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.
Secondary	Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score	From screening to week 52/early termination	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Adverse Events (AEs) - All Participants	From screening to week 52/early termination	Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score	From screening to week 52/early termination	Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.	units on a scale	MEAN
SECONDARY	Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score	From screening to week 52/early termination	Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.	units on a scale	MEAN
SECONDARY	Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score	From screening to week 52/early termination	Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score	From screening to week 52/early termination	Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Adverse Events (AEs) - All Participants	Prior Placebo	Participants with adverse events	400	Participants
Adverse Events (AEs) - All Participants	Prior Brexpiprazole	Participants with adverse events	511	Participants
Adverse Events (AEs) - All Participants	Prior ADT	Participants with adverse events	1165	Participants
Adverse Events (AEs) - All Participants	Prior Seroquel	Participants with adverse events	51	Participants
Adverse Events (AEs) - All Participants	Prior Placebo	Participants with treatment emergent AE (TEAE)	399	Participants
Adverse Events (AEs) - All Participants	Prior Brexpiprazole	Participants with treatment emergent AE (TEAE)	510	Participants
Adverse Events (AEs) - All Participants	Prior ADT	Participants with treatment emergent AE (TEAE)	1163	Participants
Adverse Events (AEs) - All Participants	Prior Seroquel	Participants with treatment emergent AE (TEAE)	51	Participants
Adverse Events (AEs) - All Participants	Prior Placebo	Participants with serious TEAE	14	Participants
Adverse Events (AEs) - All Participants	Prior Brexpiprazole	Participants with serious TEAE	23	Participants

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Prior Placebo	516
Overall Study	STARTED	Prior Brexpiprazole	707
Overall Study	STARTED	Prior ADT	1,645
Overall Study	STARTED	Prior Seroquel	76
Overall Study	COMPLETED	Prior Placebo	295
Overall Study	COMPLETED	Prior Brexpiprazole	420
Overall Study	COMPLETED	Prior ADT	1,126
Overall Study	COMPLETED	Prior Seroquel	54
Overall Study	NOT COMPLETED	Prior Placebo	221
Overall Study	NOT COMPLETED	Prior Brexpiprazole	287

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events280

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Prior Placebo	14	516
other	Constipation	Gastrointestinal disorders	Prior Brexpiprazole	15	706
other	Constipation	Gastrointestinal disorders	Prior ADT	33	1,640
other	Constipation	Gastrointestinal disorders	Prior Seroquel	4	76
other	Nausea	Gastrointestinal disorders	Prior Placebo	26	516
other	Nausea	Gastrointestinal disorders	Prior Brexpiprazole	32	706
other	Nausea	Gastrointestinal disorders	Prior ADT	61	1,640
other	Nausea	Gastrointestinal disorders	Prior Seroquel	4	76
other	Fatigue	General disorders	Prior Placebo	37	516
other	Fatigue	General disorders	Prior Brexpiprazole	50	706

1 to 10 of 280Source ClinicalTrials.gov

See all 280 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prior Placebo	2	516
Total, all-cause mortality	Prior Brexpiprazole	2	706
Total, all-cause mortality	Prior ADT	0	1,640
Total, all-cause mortality	Prior Seroquel	0	76
Total, other adverse events	Prior Placebo	296	516
Total, other adverse events	Prior Brexpiprazole	323	706
Total, other adverse events	Prior ADT	787	1,640
Total, other adverse events	Prior Seroquel	33	76
Total, serious adverse events	Prior Placebo	14	516
Total, serious adverse events	Prior Brexpiprazole	23	706

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31577867	DERIVED	PubMed
37656180	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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