Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
NCT ID: NCT01838876
Last Updated: 2019-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2013-04-29
2015-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cariprazine + ADT
Cariprazine, flexible dose (titrated to a dose of 3.0 milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Cariprazine
Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.
Antidepressant Therapy (ADT)
ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug
Interventions
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Cariprazine
Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.
Antidepressant Therapy (ADT)
ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug
Eligibility Criteria
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Inclusion Criteria
* Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD
* New patients must have ongoing inadequate response to protocol allowed ADTs as reported in Antidepressant Treatment Response Questionnaire (ATRQ)
* For rollover patients from RGH-MD-72 \[NCT01715805\], completion of Study RGH-MD-72 (either double-blind or single-blind treatment periods) with continued ADT treatment.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Gedeon Richter Ltd.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Willie Earley, MD
Role: STUDY_DIRECTOR
Allergan
Locations
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Forest Investigative Site 032
Tucson, Arizona, United States
Forest Investigative Site 109
Tucson, Arizona, United States
Forest Investigative Site 105
Fayetteville, Arkansas, United States
Forest Investigative Site 018
Little Rock, Arkansas, United States
Forest Investigative Site 029
Little Rock, Arkansas, United States
Forest Investigative Site 082
Garden Grove, California, United States
Forest Investigative Site 107
Long Beach, California, United States
Forest Investigative Site 104
National City, California, United States
Forest Investigative Site 022
Newport Beach, California, United States
Forest Investigative Site 004
Oceanside, California, United States
Forest Investigative Site 078
Rancho Mirage, California, United States
Forest Investigative Site 080
Redlands, California, United States
Forest Investigative Site 113
San Diego, California, United States
Forest Investigative Site 054
San Diego, California, United States
Forest Investigative Site 007
San Diego, California, United States
Forest Investigative Site 031
Temecula, California, United States
Forest Investigative Site 048
Denver, Colorado, United States
Forest Investigative Site 114
Norwich, Connecticut, United States
Forest Investigative Site 037
Coral Springs, Florida, United States
Forest Investigative Site 053
Fort Myers, Florida, United States
Forest Investigative Site 023
Hallandale, Florida, United States
Forest Investigative Site 071
Hialeah, Florida, United States
Forest Investigative Site 006
Leesburg, Florida, United States
Forest Investigative Site 112
Maitland, Florida, United States
Forest Investigative Site 026
Miami, Florida, United States
Forest Investigative Site 075
Miami, Florida, United States
Forest Investigative Site 027
North Miami, Florida, United States
Forest Investigative Site 074
North Miami, Florida, United States
Forest Investigative Site 036
Oakland Park, Florida, United States
Forest Investigative Site 051
Orlando, Florida, United States
Forest Investigative Site 044
South Miami, Florida, United States
Forest Investigative Site 008
Tampa, Florida, United States
Forest Investigative Site 019
Winter Park, Florida, United States
Forest Investigative Site 060
Atlanta, Georgia, United States
Forest Investigative Site 024
Atlanta, Georgia, United States
Forest Investigative Site 017
Marietta, Georgia, United States
Forest Investigative Site 047
Smyrna, Georgia, United States
Forest Investigative Site 070
Chicago, Illinois, United States
Forest Investigative Site 013
Hoffman Estates, Illinois, United States
Forest Investigative Site 063
Libertyville, Illinois, United States
Forest Investigative Site 062
Maywood, Illinois, United States
Forest Investigative Site 072
Naperville, Illinois, United States
Forest Investigative Site 010
Oak Brook, Illinois, United States
Forest Investigative Site 068
Skokie, Illinois, United States
Forest Investigative Site 061
Indianapolis, Indiana, United States
Forest Investigative Site 042
Lafayette, Indiana, United States
Forest Investigative Site 065
Overland Park, Kansas, United States
Forest Investigative Site 073
New Orleans, Louisiana, United States
Forest Investigative Site 049
Gaithersburg, Maryland, United States
Forest Investigative Site 077
Rockville, Maryland, United States
Forest Investigative Site 110
Rockville, Maryland, United States
Forest Investigative Site 046
Boston, Massachusetts, United States
Forest Investigative Site 045
Natick, Massachusetts, United States
Forest Investigative Site 103
Saint Charles, Missouri, United States
Forest Investigative Site 106
Berlin, New Jersey, United States
Forest Investigative Site 014
Toms River, New Jersey, United States
Forest Investigative Site 058
Albuquerque, New Mexico, United States
Forest Investigative Site 028
Brooklyn, New York, United States
Forest Investigative Site 016
New York, New York, United States
Forest Investigative Site 025
Staten Island, New York, United States
Forest Investigative Site 076
The Bronx, New York, United States
Forest Investigative Site 050
Durham, North Carolina, United States
Forest Investigative Site 067
Bismarck, North Dakota, United States
Forest Investigative Site 011
Cincinnati, Ohio, United States
Forest Investigative Site 015
Cincinnati, Ohio, United States
Forest Investigative Site 055
Columbus, Ohio, United States
Forest Investigative Site 066
Mason, Ohio, United States
Forest Investigative Site 064
Middleburg Heights, Ohio, United States
Forest Investigative Site 038
Oklahoma City, Oklahoma, United States
Forest Investigative Site 035
Oklahoma City, Oklahoma, United States
Forest Investigative Site 039
Oklahoma City, Oklahoma, United States
Forest Investigative Site 003
Portland, Oregon, United States
Forest Investigative Site 052
Allentown, Pennsylvania, United States
Forest Investigative Site 102
Norristown, Pennsylvania, United States
Forest Investigative Site 059
Lincoln, Rhode Island, United States
Forest Investigative Site 001
Charleston, South Carolina, United States
Forest Investigative Site 079
Austin, Texas, United States
Forest Investigative Site 005
Houston, Texas, United States
Forest Investigative Site 108
The Woodlands, Texas, United States
Forest Investigative Site 069
Wichita Falls, Texas, United States
Forest Investigative Site 111
Murray, Utah, United States
Forest Investigative Site 041
Charlottesville, Virginia, United States
Forest Investigative Site 081
Bellevue, Washington, United States
Forest Investigative Site 100
Bothell, Washington, United States
Forest Investigative Site 043
Seattle, Washington, United States
Forest Investigative Site 101
Middleton, Wisconsin, United States
Forest Investigative Site 056
Milwaukee, Wisconsin, United States
Forest Investigative Site 057
Waukesha, Wisconsin, United States
Forest Investigative Site 033
San Juan, , Puerto Rico
Forest Investigative Site 034
San Juan, , Puerto Rico
Countries
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Other Identifiers
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RGH-MD-76
Identifier Type: -
Identifier Source: org_study_id
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