An Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

Description

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

Study Start Date

November 2012

Estimated Completion Date

April 2016

Interventions

  • Drug: Placebo
  • Drug: Cariprazine

Specialties

  • Internal Medicine: Clinical Pharmacology,Psychiatry
  • Psychiatry: Mood Disorders,Neuro/Psych Pharmacol
  • Family Medicine: Clinical Pharmacology,Psychiatry
  • Pharmacy: Drug Trials,Neuro/Psych pharmacology

MeSH Terms

  • Cariprazine
  • Depressive Disorder, Major

Study ID

Forest Laboratories -- RGH-MD-72

Status

Unknown

Trial ID

NCT01715805

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

1100

Sponsor

Forest Laboratories

Inclusion Criteria

  • Patients who have provided consent prior to any specific procedure
  • Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
  • Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

Exclusion Criteria

  • Patients who do not meet DSM-IV-TR criteria for MDD

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (132)

Study Location Distance Name Phone Email
Forest Investigative Site 076 - Bronx, New York 40.3 miles None None None
Forest Investigative Site 083 - New York, New York 48.5 miles None None None
Forest Investigative Site 016 - New York, New York 49.1 miles None None None
Forest Investigative Site 016 - New York, New York 49.1 miles None None None
Forest Investigative Site 028 - Brooklyn, New York 58.0 miles None None None
Forest Investigative Site 028 - Brooklyn, New York 58.0 miles None None None
Forest Investigative Site 025 - Staten Island, New York 61.0 miles None None None
Forest Investigative Site 025 - Staten Island, New York 61.0 miles None None None
Forest Investigative Site 014 - Toms River, New Jersey 98.6 miles None None None
Forest Investigative Site 014 - Toms River, New Jersey 98.6 miles None None None
Forest Investigative Site 059 - Lincoln, Rhode Island 112.2 miles None None None
Forest Investigative Site 059 - Lincoln, Rhode Island 112.2 miles None None None
Forest Investigative Site 045 - Natick, Massachusetts 122.8 miles None None None
Forest Investigative Site 052 - Allentown, Pennsylvania 126.7 miles None None None
Forest Investigative Site 046 - Boston, Massachusetts 135.3 miles None None None
Forest Investigative Site 046 - Boston, Massachusetts 135.3 miles None None None
Forest Investigative Site 049 - Gaithersburg, Maryland 253.4 miles None None None
Forest Investigative Site 012 - Rockville, Maryland 253.9 miles None None None
Forest Investigative Site 077 - Rockville, Maryland 254.8 miles None None None
Forest Investigative Site 077 - Rockville, Maryland 254.8 miles None None None
Forest Investigative Site 041 - Charlottesville, Virginia 356.4 miles None None None
Forest Investigative Site 041 - Charlottesville, Virginia 356.4 miles None None None
Forest Investigative Site 088 - Canton, Ohio 428.6 miles None None None
Forest Investigative Site 064 - Middleburg Heights, Ohio 444.4 miles None None None
Forest Investigative Site 050 - Durham, North Carolina 474.7 miles None None None
Forest Investigative Site 050 - Durham, North Carolina 474.7 miles None None None
Forest Investigative Site 055 - Columbus, Ohio 520.3 miles None None None
Forest Investigative Site 066 - Mason, Ohio 598.4 miles None None None
Forest Investigative Site 015 - Cincinnati, Ohio 605.1 miles None None None
Forest Investigative Site 015 - Cincinnati, Ohio 605.1 miles None None None
Forest Investigative Site 089 - Cincinnati, Ohio 609.0 miles None None None
Forest Investigative Site 089 - Cincinnati, Ohio 609.0 miles None None None
Forest Investigative Site 011 - Cincinnati, Ohio 613.2 miles None None None
Forest Investigative Site 042 - Lafayette, Indiana 637.7 miles None None None
Forest Investigative Site 042 - Lafayette, Indiana 637.7 miles None None None
Forest Investigative Site 001 - North Charleston, South Carolina 685.1 miles None None None
Forest Investigative Site 061 - Indianapolis, Indiana 686.2 miles None None None
Forest Investigative Site 070 - Chicago, Illinois 748.9 miles None None None
Forest Investigative Site 070 - Chicago, Illinois 748.9 miles None None None
Forest Investigative Site 068 - Skokie, Illinois 751.0 miles None None None
Forest Investigative Site 068 - Skokie, Illinois 751.0 miles None None None
Forest Investigative Site 062 - Maywood, Illinois 757.2 miles None None None
Forest Investigative Site 062 - Maywood, Illinois 757.2 miles None None None
Forest Investigative Site 010 - Oak Brook, Illinois 762.0 miles None None None
Forest Investigative Site 010 - Oak Brook, Illinois 762.0 miles None None None
Forest Investigative Site 063 - Libertyville, Illinois 762.4 miles None None None
Forest Investigative Site 063 - Libertyville, Illinois 762.4 miles None None None
Forest Investigative Site 013 - Hoffman Estates, Illinois 765.2 miles None None None
Forest Investigative Site 056 - Milwaukee, Wisconsin 769.0 miles None None None
Forest Investigative Site 072 - Naperville, Illinois 773.7 miles None None None
Forest Investigative Site 072 - Naperville, Illinois 773.7 miles None None None
Forest Investigative Site 057 - Waukesha, Wisconsin 780.4 miles None None None
Forest Investigative Site 060 - Atlanta, Georgia 796.9 miles None None None
Forest Investigative Site 060 - Atlanta, Georgia 796.9 miles None None None
Forest Investigative Site 017 - Marietta, Georgia 797.5 miles None None None
Forest Investigative Site 017 - Marietta, Georgia 797.5 miles None None None
Forest Investigative Site 024 - Atlanta, Georgia 798.9 miles None None None
Forest Investigative Site 024 - Atlanta, Georgia 798.9 miles None None None
Forest Investigative Site 086 - St. Charles, Missouri 936.4 miles None None None
Forest Investigative Site 086 - St. Charles, Missouri 936.4 miles None None None
Forest Investigative Site 019 - Winter Park, Florida 986.9 miles None None None
Forest Investigative Site 019 - Winter Park, Florida 986.9 miles None None None
Forest Investigative Site 006 - Leesburg, Florida 988.3 miles None None None
Forest Investigative Site 006 - Leesburg, Florida 988.3 miles None None None
Forest Investigative Site 051 - Orlando, Florida 989.4 miles None None None
Forest Investigative Site 051 - Orlando, Florida 989.4 miles None None None
Forest Investigative Site 008 - Tampa, Florida 1,049.0 miles None None None
Forest Investigative Site 037 - Coral Springs, Florida 1,107.0 miles None None None
Forest Investigative Site 036 - Oakland Park, Florida 1,113.7 miles None None None
Forest Investigative Site 036 - Oakland Park, Florida 1,113.7 miles None None None
Forest Investigative Site 074 - Lauderhill, Florida 1,115.2 miles None None None
Forest Investigative Site 029 - Little Rock, Arkansas 1,129.0 miles None None None
Forest Investigative Site 029 - Little Rock, Arkansas 1,129.0 miles None None None
Forest Investigative Site 053 - Fort Myers, Florida 1,130.7 miles None None None
Forest Investigative Site 053 - Fort Myers, Florida 1,130.7 miles None None None
Forest Investigative Site 027 - North Miami, Florida 1,133.6 miles None None None
Forest Investigative Site 027 - North Miami, Florida 1,133.6 miles None None None
Forest Investigative Site 018 - Little Rock, Arkansas 1,136.2 miles None None None
Forest Investigative Site 018 - Little Rock, Arkansas 1,136.2 miles None None None
Forest Investigative Site 040 - Hialeah, Florida 1,137.7 miles None None None
Forest Investigative Site 071 - Hialeah, Florida 1,137.7 miles None None None
Forest Investigative Site 023 - Hallandale Beach, Florida 1,140.1 miles None None None
Forest Investigative Site 065 - Overland Park, Kansas 1,141.8 miles None None None
Forest Investigative Site 026 - Miami, Florida 1,143.8 miles None None None
Forest Investigative Site 026 - Miami, Florida 1,143.8 miles None None None
Forest Investigative Site 075 - Miami, Florida 1,147.7 miles None None None
Forest Investigative Site 075 - Miami, Florida 1,147.7 miles None None None
Forest Investigative Site 044 - South Miami, Florida 1,148.3 miles None None None
Forest Investigative Site 073 - New Orleans, Louisiana 1,226.2 miles None None None
Forest Investigative Site 073 - New Orleans, Louisiana 1,226.2 miles None None None
Forest Investigative Site 035 - Oklahoma City, Oklahoma 1,371.6 miles None None None
Forest Investigative Site 038 - Oklahoma City, Oklahoma 1,373.5 miles None None None
Forest Investigative Site 039 - Oklahoma City, Oklahoma 1,373.5 miles None None None
Forest Investigative Site 038 - Oklahoma City, Oklahoma 1,373.5 miles None None None
Forest Investigative Site 067 - Bismarck, North Dakota 1,417.0 miles None None None
Forest Investigative Site 067 - Bismarck, North Dakota 1,417.0 miles None None None
Forest Investigative Site 087 - The Woodlands, Texas 1,460.2 miles None None None
Forest Investigative Site 087 - The Woodlands, Texas 1,460.2 miles None None None
Forest Investigative Site 069 - Wichita Falls, Texas 1,472.0 miles None None None
Forest Investigative Site 069 - Wichita Falls, Texas 1,472.0 miles None None None
Forest Investigative Site 005 - Houston, Texas 1,472.7 miles None None None
Forest Investigative Site 079 - Austin, Texas 1,567.3 miles None None None
Forest Investigative Site 048 - Denver, Colorado 1,657.0 miles None None None
Forest Investigative Site 048 - Denver, Colorado 1,657.0 miles None None None
Forest Investigative Site 058 - Albuquerque, New Mexico 1,849.7 miles None None None
Forest Investigative Site 030 - Orem, Utah 2,002.0 miles None None None
Forest Investigative Site 030 - Orem, Utah 2,002.0 miles None None None
Forest Investigative Site 032 - Tucson, Arizona 2,220.2 miles None None None
Forest Investigative Site 032 - Tucson, Arizona 2,220.2 miles None None None
Forest Investigative Site 081 - Bellevue, Washington 2,418.1 miles None None None
Forest Investigative Site 043 - Seattle, Washington 2,426.6 miles None None None
Forest Investigative Site 080 - Redlands, California 2,432.7 miles None None None
Forest Investigative Site 078 - Redlands, California 2,432.7 miles None None None
Forest Investigative Site 078 - Redlands, California 2,432.7 miles None None None
Forest Investigative Site 080 - Redlands, California 2,432.7 miles None None None
Forest Investigative Site 031 - Temecula, California 2,445.3 miles None None None
Forest Investigative Site 031 - Temecula, California 2,445.3 miles None None None
Forest Investigative Site 020 - Riverside, California 2,446.6 miles None None None
Forest Investigative Site 004 - Oceanside, California 2,464.5 miles None None None
Forest Investigative Site 004 - Oceanside, California 2,464.5 miles None None None
Forest Investigative Site 003 - Portland, Oregon 2,468.8 miles None None None
Forest Investigative Site 007 - San Diego, California 2,469.3 miles None None None
Forest Investigative Site 054 - San Diego, California 2,470.1 miles None None None
Forest Investigative Site 022 - Newport Beach, California 2,482.2 miles None None None
Forest Investigative Site 009 - Costa Mesa, California 2,482.8 miles None None None
Forest Investigative Site 084 - Cerritos, California 2,484.5 miles None None None
Forest Investigative Site 084 - Cerritos, California 2,484.5 miles None None None
Forest Investigative Site 082 - Garden Grove, California 2,485.9 miles None None None
Forest Investigative Site 082 - Garden Grove, California 2,485.9 miles None None None
Forest Investigative Site 002 - Paramount, California 2,486.1 miles None None None
Forest Investigative Site 002 - Paramount, California 2,486.1 miles None None None
Forest Investigative Site 085 - Culver City, California 2,498.5 miles None None None

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