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
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 | |
|---|---|---|---|---|
| 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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