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

Primary Purpose

Depressive Disorder, Depression, Depressive Disorder, Major

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

OPC-34712

Escitalopram

Fluoxetine

Paroxetine CR

Sertraline

Duloxetine

Venlafaxine XR

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring OPC-34712, brexpiprazole, Major Depressive Disorder, Adjunctive Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

OPC-34712 (Brexpiprazole) and Escitalopram

OPC-34712 and Fluoxetine

OPC-34712 and Paroxetine CR

OPC-34712 and Sertraline

OPC-34712 and Duloxetine

OPC-34712 and Venlafaxine XR

Arm Description

OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day

OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day

OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day

OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day

OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day

OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day

Outcomes

Primary Outcome Measures

Adverse Events (AEs) - All Participants

To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT01360866

First Posted

May 24, 2011

Last Updated

September 14, 2018

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01360866

Brief Title

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

Acronym

Orion

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 2011 (Actual)

Primary Completion Date

April 18, 2017 (Actual)

Study Completion Date

May 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

OPC-34712, brexpiprazole, Major Depressive Disorder, Adjunctive Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2944 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OPC-34712 (Brexpiprazole) and Escitalopram

Arm Type

Experimental

Arm Description

OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day

Arm Title

OPC-34712 and Fluoxetine

Arm Type

Experimental

Arm Description

OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day

Arm Title

OPC-34712 and Paroxetine CR

Arm Type

Experimental

Arm Description

OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day

Arm Title

OPC-34712 and Sertraline

Arm Type

Experimental

Arm Description

OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day

Arm Title

OPC-34712 and Duloxetine

Arm Type

Experimental

Arm Description

OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day

Arm Title

OPC-34712 and Venlafaxine XR

Arm Type

Experimental

Arm Description

OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day

Intervention Type

Drug

Intervention Name(s)

OPC-34712

Intervention Description

Tablet

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Lexapro

Intervention Description

Tablet

Intervention Type

Drug

Intervention Name(s)

Fluoxetine

Other Intervention Name(s)

Prozac

Intervention Description

Capsule

Intervention Type

Drug

Intervention Name(s)

Paroxetine CR

Other Intervention Name(s)

Paxil CR

Intervention Description

Controlled-release tablets

Intervention Type

Drug

Intervention Name(s)

Sertraline

Other Intervention Name(s)

Zoloft

Intervention Description

Tablets

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

Delayed-release capsules

Intervention Type

Drug

Intervention Name(s)

Venlafaxine XR

Other Intervention Name(s)

Effexor XR

Intervention Description

Extended-release capsules

Primary Outcome Measure Information:

Title

Adverse Events (AEs) - All Participants

Description

To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.

Time Frame