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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01360866
Other study ID # 331-10-238
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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