Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,539

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

September 30, 2013

Conditions
Depressive DisorderDepressionDepressive Disorder, MajorMood DisordersMental Disorders
Interventions
DRUG

OPC-34712 + ADT

Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)

DRUG

Placebo + ADT

Placebo + FDA Approved Antidepressant (ADT)

DRUG

Placebo + ADT

Placebo + FDA Approved Antidepressant (ADT)

Trial Locations (71)

Unknown

Research Site, Birmingham

Research Site, Costa Mesa

Research Site, Glendale

Research Site, Orange

Research Site, San Diego

Research Site, Temecula

Research Site, Jacksonville

Research Site, Jacksonville Beach

Research Site, Miami Springs

Research Site, Tampa

Research Site, Winter Park

Research Site, Atlanta

Research Site, Smyrna

Research Site, Chicago

Research Site, Oak Brook

Research Site, Lafayette

Research Site, Owensboro

Research Site, Baltimore

Research Site, Haverhill

Research Site, Weymouth

Research Site, Rochester Hills

Research Site, Creve Coeur

Research Site, Las Vegas

Research Site, Cherry Hill

Research Site, Toms River

Research Site, Brooklyn

Research Site, Fresh Meadows

Research Site, New York

Research Site, Staten Island

Research Site, Raleigh

Research Site, Beachwood

Research Site, Cincinnati

Research Site, Columbus

Research Site, Oklahoma City

Research Site, Portland

Salem

Research Site, Norristown

Research Site, Philadelphia

Research Site, Lincoln

Research Site, Columbia

Research Site, Memphis

Research Site, Austin

Research Site, Dallas

Research Site, Houston

Research Site, San Antonio

Research Site, Witchita Falls

Research Site, Charlottesville

Research Site, Herndon

Research Site, Bellevue

Research Site, Spokane

Research Site, Brown Deer

Research Site, Middleton

Research Site, Toronto

Research Site, Pointe-Claire

Research Site, Würzburg

Research Site, Stralsund

Research Site, Bochum

Research Site, Achim

Research Site, Nyíregyháza

Research Site, Budapest

Research Site, Győr

Research Site, Bucharest

Research Site, Lasi

Research Site, Târgu Mureş

Research Site, Moscow

Research Site, Rostov-on-Don

Research Site, Saint Petersburg

Research Site, Chenigiv

Research Site, Kharkiv

Research Site, Kiev

Research Site, Poltava

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT01360632 - Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial) | Biotech Hunter | Biotech Hunter