Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
NCT ID: NCT01715805
Last Updated: 2019-08-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1022 participants
INTERVENTIONAL
2012-11-15
2016-06-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
NCT01838876
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
NCT03738215
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
NCT01469377
A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder
NCT03093025
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
NCT01436162
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo + ADT Lead-in
Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
Placebo
Dose-matched placebo capsule once per day
Antidepressant Therapy (ADT)
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Placebo + ADT (Double-Blind)
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
Placebo
Dose-matched placebo capsule once per day
Antidepressant Therapy (ADT)
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Cariprazine + ADT (Double-Blind)
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
Cariprazine
Cariprazine capsules 1.5 to 4.5 mg/day
Antidepressant Therapy (ADT)
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Placebo + ADT (Continued Treatment)
Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.
Placebo
Dose-matched placebo capsule once per day
Antidepressant Therapy (ADT)
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cariprazine
Cariprazine capsules 1.5 to 4.5 mg/day
Placebo
Dose-matched placebo capsule once per day
Antidepressant Therapy (ADT)
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gedeon Richter Ltd.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Willie Earley, MD
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Forest Investigative Site 032
Tucson, Arizona, United States
Forest Investigative Site 018
Little Rock, Arkansas, United States
Forest Investigative Site 029
Little Rock, Arkansas, United States
Forest Investigative Site 084
Cerritos, California, United States
Forest Investigative Site 085
Culver City, California, United States
Forest Investigative Site 082
Garden Grove, California, United States
Forest Investigative Site 022
Newport Beach, California, United States
Forest Investigative Site 004
Oceanside, California, United States
Forest Investigative Site 090
Rancho Mirage, California, United States
Forest Investigative Site 078
Redlands, California, United States
Forest Investigative Site 080
Redlands, California, United States
Forest Investigative Site 007
San Diego, California, United States
Forest Investigative Site 054
San Diego, California, United States
Forest Investigative Site 031
Temecula, California, United States
Forest Investigative Site 048
Denver, Colorado, 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 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 012
Rockville, Maryland, United States
Forest Investigative Site 046
Boston, Massachusetts, United States
Forest Investigative Site 045
Natick, Massachusetts, United States
Forest Investigative Site 086
Saint Charles, Missouri, 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 083
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 088
Canton, Ohio, United States
Forest Investigative Site 089
Cincinnati, Ohio, 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 035
Oklahoma City, Oklahoma, United States
Forest Investigative Site 038
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 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 087
The Woodlands, Texas, United States
Forest Investigative Site 069
Wichita Falls, Texas, United States
Forest Investigative Site 030
Orem, Utah, United States
Forest Investigative Site 041
Charlottesville, Virginia, United States
Forest Investigative Site 081
Bellevue, Washington, United States
Forest Investigative Site 043
Seattle, Washington, 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
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RGH-MD-72
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.