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

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360866
• Other study ID #: 331-10-238
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: May 18, 2017

Study information

• Verified date: September 2018
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2944
• Est. completion date: May 18, 2017
• Est. primary completion date: April 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorders

Intervention

Drug:
• OPC-34712
Tablet
• Escitalopram
Tablet
• Fluoxetine
Capsule
• Paroxetine CR
Controlled-release tablets
• Sertraline
Tablets
• Duloxetine
Delayed-release capsules
• Venlafaxine XR
Extended-release capsules

Locations

Country	Name	City	State
Canada	Research Site	Gatineau
Canada	Research Site	Penticton
Canada	Research Site	Pointe-Claire
Canada	Research Site	Sherbrooke
Canada	Research Site	Toronto
France	Research Site	Arcachon
France	Research Site	Douai
France	Research Site	Elancourt
France	Research Site	Jarnac
France	Research Site	Orvault
France	Research Site	Palaiseau
France	Research Site	Toulouse
Germany	Research Site	Achim
Germany	Research Site	Bochum
Germany	Research Site	Mittweida
Germany	Research Site	Stralsund
Germany	Research Site	Wurzburg
Hungary	Research Site	Budapest
Poland	Research Site	Belchatow
Poland	Research Site	Bydgoszcz
Poland	Research Site	Katowice
Poland	Research Site	Kielce
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Pruszcz Gdanski
Poland	Research Site	Tuszyn
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Romania	Research Site	Bucharest
Romania	Research Site	Ia?i
Romania	Research Site	Târgu-Mures
Russian Federation	Research Site	Arkhangelsk Region
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Roshchino
Russian Federation	Research Site	Rostov-na-Donu
Russian Federation	Research Site	Saint Petersberg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Smolensk
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Tonnel'nyy
Serbia	Research Site	Belgrade
Serbia	Research Site	Kragujevac
Serbia	Research Site	Nis
Serbia	Research Site	Novi Knezevac
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Košice
Slovakia	Research Site	Michalovce
Ukraine	Research Site	Chernihiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kiev
Ukraine	Research Site	Poltava
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Alpharetta	Georgia
United States	Research Site	Arlington	Texas
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bala-Cynwyd	Pennsylvania
United States	Research Site	Baltimore	Maryland
United States	Research Site	Beachwood	Ohio
United States	Research Site	Bellevue	Washington
United States	Research Site	Belmont	Massachusetts
United States	Research Site	Beverly Hills	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bridgeville	Pennsylvania
United States	Research Site	Brooklyn	New York
United States	Research Site	Brown Deer	Wisconsin
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Cherry Hill	New Jersey
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbus	Ohio
United States	Research Site	Coral Gables	Florida
United States	Research Site	Coral Springs	Florida
United States	Research Site	Costa Mesa	California
United States	Research Site	Creve Coeur	Missouri
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Decatur	Georgia
United States	Research Site	Fort Myers	Florida
United States	Research Site	Gainesville	Florida
United States	Research Site	Glendale	California
United States	Research Site	Herndon	Virginia
United States	Research Site	Hialeah	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Irvine	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville Beach	Florida
United States	Research Site	Jamaica	New York
United States	Research Site	Kirkland	Washington
United States	Research Site	Lafayette	Indiana
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lincoln	Rhode Island
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Melbourne	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Methuen	Massachusetts
United States	Research Site	Miami	Florida
United States	Research Site	Miami Springs	Florida
United States	Research Site	Middleton	Wisconsin
United States	Research Site	Murray	Utah
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Norristown	Pennsylvania
United States	Research Site	Norwalk	Connecticut
United States	Research Site	Oak Brook	Illinois
United States	Research Site	Oakland Park	Florida
United States	Research Site	Oceanside	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Portland	Oregon
United States	Research Site	Prairie Village	Kansas
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Redlands	California
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Rochester Hills	Michigan
United States	Research Site	Salem	Oregon
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Francisco	California
United States	Research Site	Santa Ana	California
United States	Research Site	Seattle	Washington
United States	Research Site	Sherman Oaks	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Smyrna	Georgia
United States	Research Site	Spokane	Washington
United States	Research Site	Staten Island	New York
United States	Research Site	Temecula	California
United States	Research Site	The Villages	Florida
United States	Research Site	Toledo	Ohio
United States	Research Site	Tom River	New Jersey
United States	Research Site	Upland	California
United States	Research Site	Watertown	Massachusetts
United States	Research Site	Weymouth	Massachusetts
United States	Research Site	Wichita	Kansas
United States	Research Site	Wichita Falls	Texas
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winter Park	Florida
United States	Research Site	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hungary,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs) - All Participants	To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.	From screening to week 52/early termination
Secondary	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.	From screening to week 52/early termination
Secondary	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.	From screening to week 52/early termination
Secondary	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.	From screening to week 52/early termination
Secondary	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.	From screening to week 52/early termination