Clinical trial NCT01360866: Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Keywords: OPC-34712
brexpiprazole
Major Depressive Disorder
Adjunctive Treatment
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 2944
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events (AEs) - All Participants
timeFrame: From screening to week 52/early termination
Secondary outcomes:
measure: Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
timeFrame: From screening to week 52/early termination
measure: Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: From screening to week 52/early termination
measure: Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
timeFrame: From screening to week 52/early termination
measure: Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score
timeFrame: From screening to week 52/early termination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Beverly Hills
country: United States
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state: California
city: Costa Mesa
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state: California
city: Glendale
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state: California
city: Irvine
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state: California
city: Oceanside
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city: Coral Gables
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city: Coral Springs
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city: Woodstock
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city: Herndon
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country: France
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country: France
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country: France
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country: France
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Budapest
country: Hungary
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city: Belchatow
country: Poland
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country: Poland
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country: Romania
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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city: Rostov-na-Donu
country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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city: St. Petersburg
country: Russian Federation
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country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Novi Knezevac
country: Serbia
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city: Bratislava
country: Slovakia
facility: Research Site
city: Košice
country: Slovakia
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city: Michalovce
country: Slovakia
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city: Chernihiv
country: Ukraine
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city: Kharkiv
country: Ukraine
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city: Kiev
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
Study officials:
References:
citation: 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.