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

Otsuka

Status and phase: Completed; Phase 3

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

Treatments: Drug: Venlafaxine XR; Drug: Duloxetine; Drug: Fluoxetine; Drug: Paroxetine CR; Drug: OPC-34712; Drug: Escitalopram; Drug: Sertraline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360866

331-10-238

Details and patient eligibility

About

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)

Enrollment: 2,944 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,944 participants in 6 patient groups

OPC-34712 (Brexpiprazole) and Escitalopram

Experimental group

Description:

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

Treatment:

Drug: Escitalopram

Drug: OPC-34712

OPC-34712 and Fluoxetine

Experimental group

Description:

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

Treatment:

Drug: OPC-34712

Drug: Fluoxetine

OPC-34712 and Paroxetine CR

Experimental group

Description:

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

Treatment:

Drug: OPC-34712

Drug: Paroxetine CR

OPC-34712 and Sertraline

Experimental group

Description:

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

Treatment:

Drug: Sertraline

Drug: OPC-34712

OPC-34712 and Duloxetine

Experimental group

Description:

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

Treatment:

Drug: OPC-34712

Drug: Duloxetine

OPC-34712 and Venlafaxine XR

Experimental group

Description:

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

Treatment:

Drug: OPC-34712

Drug: Venlafaxine XR