Major Depressive Disorder Clinical Trial
Official title:
A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
Verified date | August 2019 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 1022 |
Est. completion date | June 24, 2016 |
Est. primary completion date | June 24, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Forest Investigative Site 033 | San Juan | |
Puerto Rico | Forest Investigative Site 034 | San Juan | |
United States | Forest Investigative Site 058 | Albuquerque | New Mexico |
United States | Forest Investigative Site 052 | Allentown | Pennsylvania |
United States | Forest Investigative Site 024 | Atlanta | Georgia |
United States | Forest Investigative Site 060 | Atlanta | Georgia |
United States | Forest Investigative Site 079 | Austin | Texas |
United States | Forest Investigative Site 081 | Bellevue | Washington |
United States | Forest Investigative Site 067 | Bismarck | North Dakota |
United States | Forest Investigative Site 046 | Boston | Massachusetts |
United States | Forest Investigative Site 076 | Bronx | New York |
United States | Forest Investigative Site 028 | Brooklyn | New York |
United States | Forest Investigative Site 088 | Canton | Ohio |
United States | Forest Investigative Site 084 | Cerritos | California |
United States | Forest Investigative Site 001 | Charleston | South Carolina |
United States | Forest Investigative Site 041 | Charlottesville | Virginia |
United States | Forest Investigative Site 070 | Chicago | Illinois |
United States | Forest Investigative Site 011 | Cincinnati | Ohio |
United States | Forest Investigative Site 015 | Cincinnati | Ohio |
United States | Forest Investigative Site 089 | Cincinnati | Ohio |
United States | Forest Investigative Site 055 | Columbus | Ohio |
United States | Forest Investigative Site 037 | Coral Springs | Florida |
United States | Forest Investigative Site 085 | Culver City | California |
United States | Forest Investigative Site 048 | Denver | Colorado |
United States | Forest Investigative Site 050 | Durham | North Carolina |
United States | Forest Investigative Site 053 | Fort Myers | Florida |
United States | Forest Investigative Site 049 | Gaithersburg | Maryland |
United States | Forest Investigative Site 082 | Garden Grove | California |
United States | Forest Investigative Site 023 | Hallandale Beach | Florida |
United States | Forest Investigative Site 071 | Hialeah | Florida |
United States | Forest Investigative Site 013 | Hoffman Estates | Illinois |
United States | Forest Investigative Site 005 | Houston | Texas |
United States | Forest Investigative Site 061 | Indianapolis | Indiana |
United States | Forest Investigative Site 042 | Lafayette | Indiana |
United States | Forest Investigative Site 006 | Leesburg | Florida |
United States | Forest Investigative Site 063 | Libertyville | Illinois |
United States | Forest Investigative Site 059 | Lincoln | Rhode Island |
United States | Forest Investigative Site 018 | Little Rock | Arkansas |
United States | Forest Investigative Site 029 | Little Rock | Arkansas |
United States | Forest Investigative Site 017 | Marietta | Georgia |
United States | Forest Investigative Site 066 | Mason | Ohio |
United States | Forest Investigative Site 062 | Maywood | Illinois |
United States | Forest Investigative Site 026 | Miami | Florida |
United States | Forest Investigative Site 075 | Miami | Florida |
United States | Forest Investigative Site 064 | Middleburg Heights | Ohio |
United States | Forest Investigative Site 056 | Milwaukee | Wisconsin |
United States | Forest Investigative Site 072 | Naperville | Illinois |
United States | Forest Investigative Site 045 | Natick | Massachusetts |
United States | Forest Investigative Site 073 | New Orleans | Louisiana |
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 022 | Newport Beach | California |
United States | Forest Investigative Site 027 | North Miami | Florida |
United States | Forest Investigative Site 074 | North Miami | Florida |
United States | Forest Investigative Site 010 | Oak Brook | Illinois |
United States | Forest Investigative Site 036 | Oakland Park | Florida |
United States | Forest Investigative Site 004 | Oceanside | California |
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 030 | Orem | Utah |
United States | Forest Investigative Site 051 | Orlando | Florida |
United States | Forest Investigative Site 065 | Overland Park | Kansas |
United States | Forest Investigative Site 003 | Portland | Oregon |
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 012 | Rockville | Maryland |
United States | Forest Investigative Site 077 | Rockville | Maryland |
United States | Forest Investigative Site 086 | Saint Charles | Missouri |
United States | Forest Investigative Site 007 | San Diego | California |
United States | Forest Investigative Site 054 | San Diego | California |
United States | Forest Investigative Site 043 | Seattle | Washington |
United States | Forest Investigative Site 068 | Skokie | Illinois |
United States | Forest Investigative Site 047 | Smyrna | Georgia |
United States | Forest Investigative Site 044 | South Miami | Florida |
United States | Forest Investigative Site 025 | Staten Island | New York |
United States | Forest Investigative Site 008 | Tampa | Florida |
United States | Forest Investigative Site 031 | Temecula | California |
United States | Forest Investigative Site 087 | The Woodlands | Texas |
United States | Forest Investigative Site 014 | Toms River | New Jersey |
United States | Forest Investigative Site 032 | Tucson | Arizona |
United States | Forest Investigative Site 057 | Waukesha | Wisconsin |
United States | Forest Investigative Site 069 | Wichita Falls | Texas |
United States | Forest Investigative Site 019 | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories | Gedeon Richter Ltd. |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period | The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. | Baseline (Week 8) | |
Primary | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period | The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses. | Baseline (Week 8) to Week 16 | |
Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period | The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses. | Baseline (Week 8) to Week 16 |
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