Clinical trial NCT03739203: 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 Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
Official title: A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 who have had an inadequate response to antidepressants alone.


Eligibility criteria: Inclusion Criteria:

* Written informed consent has been obtained.
* Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information \[US sites\] and written Data Protection consent \[EU sites\]).
* Participant must be an outpatient at the time of Visit 1 (Screening).
* Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD based on Structured Clinical Interview for DSM-5 (SCID-5), with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
* Diagnosis of MDD confirmed through a formal adjudication process.
* Participant demonstrates ability to follow study instructions and likely to complete all required visits.
* Participant must have an inadequate response, as measured by the modified antidepressant treatment response questionnaire (ATRQ), to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
* Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and Participants must agree to continue taking the same ADT dosing regimen through completion of Visit 6/early termination (ET). Participants who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
* Male and female Participants must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
* Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria:

* Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
* Participant has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.

Primary outcomes:
measure: Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex /ID# 236936
state: Alabama
city: Little Rock
country: United States
facility: Woodland International Research Group /ID# 236349
state: Arkansas
city: Anaheim
country: United States
facility: California Pharmaceutical Research Institute /ID# 236731
state: California
city: Colton
country: United States
facility: Axiom Research /ID# 236267
state: California
city: Costa Mesa
country: United States
facility: Global Clinical Trials /ID# 235059
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research - Orange County /ID# 237637
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC /ID# 236622
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center /ID# 236560
state: California
city: Oceanside
country: United States
facility: North County Clinical Research /ID# 235014
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc /ID# 237717
state: California
city: Orange
country: United States
facility: NRC Research Institute /ID# 234632
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research /ID# 236624
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research /ID# 237408
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc. /ID# 236636
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute /ID# 236445
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group /ID# 234378
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers /ID# 236927
state: Colorado
city: Cromwell
country: United States
facility: CT Clinical Research /ID# 234638
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Innovative Clinical Research /ID# 235186
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center /ID# 236280
state: Florida
city: Miami
country: United States
facility: Innova Clinical Trials /ID# 237376
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC /ID# 237410
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida /ID# 237326
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc /ID# 236604
state: Florida
city: Palm Bay
country: United States
facility: Space Coast Neuropsychiatric Research Institute /ID# 235766
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research /ID# 234696
state: Georgia
city: Atlanta
country: United States
facility: Institute for Advanced Medical Research /ID# 234992
state: Georgia
city: Savannah
country: United States
facility: iResearch Savannah /ID# 236082
state: Georgia
city: Smyrna
country: United States
facility: Iris Research Inc. /ID# 234995
state: Georgia
city: Naperville
country: United States
facility: AMR Conventions Research /ID# 236262
state: Illinois
city: Prairie Village
country: United States
facility: Collective Medical Research /ID# 236397
state: Kansas
city: Boston
country: United States
facility: Boston Clinical Trials /ID# 236558
state: Massachusetts
city: New Bedford
country: United States
facility: BTC of New Bedford /ID# 236381
state: Massachusetts
city: South Weymouth
country: United States
facility: The Coastal Research Associates Inc /ID# 235056
state: Massachusetts
city: Springfield
country: United States
facility: Sisu at Renaissance Medical Group /ID# 236198
state: Massachusetts
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness /ID# 236630
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health, Inc /ID# 238209
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trails /ID# 236657
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research /ID# 234961
state: New York
city: New York
country: United States
facility: Fieve Clinical Research, Inc. /ID# 236632
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center LLC /ID# 236094
state: New York
city: Hickory
country: United States
facility: Clinical Trials America /ID# 237636
state: North Carolina
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake /ID# 236281
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC /ID# 236743
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research LL /ID# 235076
state: Ohio
city: West Chester
country: United States
facility: CincyScience /ID# 236387
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute (LHSI) /ID# 237612
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research /ID# 238295
state: Oklahoma
city: Salem
country: United States
facility: Oregon Ctr for Clin Inv /ID# 237463
state: Oregon
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies LLC /ID# 238153
state: Pennsylvania
city: Franklin
country: United States
facility: Psychiatric Consultants PC /ID# 235838
state: Tennessee
city: Memphis
country: United States
facility: Research Strategies of Memphis /ID# 236629
state: Tennessee
city: Friendswood
country: United States
facility: Earle Research /ID# 236660
state: Texas
city: Plano
country: United States
facility: AIM Trials /ID# 236366
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc /ID# 237864
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands /ID# 236423
state: Texas
city: Woodstock
country: United States
facility: Woodstock Research Center /ID# 236653
state: Vermont
city: Madison
country: United States
facility: SSM Health Dean Medical Group /ID# 238103
state: Wisconsin
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials /ID# 235707
state: Ontario
city: Ottawa
country: Canada
facility: Introspect Clinical Research Centre /ID# 235987
state: Ontario
city: Ottawa
country: Canada
facility: Recherches Neuro-Hippocampe Inc. d/b/a Ottawa Memory Clinic /ID# 235890
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc. /ID# 234385
state: Quebec
city: Praha 6
country: Czechia
facility: Medical Services Prague /ID# 235109
state: Praha, Hlavni Mesto
city: Brno
country: Czechia
facility: Saint Anne s.r.o. /ID# 235060
city: Brno
country: Czechia
facility: MUDr. Marta Holanova /ID# 235126
city: Hradec Kralove
country: Czechia
facility: Neuropsychiatriehk s.r.o. /ID# 236195
city: Plzen
country: Czechia
facility: A-SHINE s.r.o. /ID# 236370
city: Prague 10
country: Czechia
facility: CLINTRIAL s.r.o. /ID# 237794
city: Praha
country: Czechia
facility: INEP medical s.r.o. /ID# 236291
city: Helsinki
country: Finland
facility: Helsingin psykiatripalvelu /ID# 235090
city: Helsinki
country: Finland
facility: Mederon Oy /ID# 235057
city: Kuopio
country: Finland
facility: Savon Psykiatripalvelu Oy /ID# 235028
city: Oulu
country: Finland
facility: Oulu Mentalcare Oy /ID# 235089
city: Rauma
country: Finland
facility: Satakunnan Psykiatripalvelu Oy /ID# 234936
city: Tampere
country: Finland
facility: Psykiatri- ja psykologikeskus Mentoria /ID# 235091
city: Belchatow
country: Poland
facility: Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851
state: Lodzkie
city: Lublin
country: Poland
facility: Centrum Medyczne Luxmed /ID# 235110
state: Lubelskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 237466
state: Pomorskie
city: Szczecin
country: Poland
facility: Zachodniopomorski Instytut Psychoterapii /ID# 236549
state: Zachodniopomorskie
city: Bia?ystok
country: Poland
facility: Wlokiennicza Med /ID# 235105
city: Bialystok
country: Poland
facility: MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065
city: Bydgoszcz
country: Poland
facility: Przychodnia Srodmiescie Sp. Z o.o. /ID# 236197
city: Bydgoszcz
country: Poland
facility: Med-Art /Id# 234986
city: Chelmno
country: Poland
facility: Poradnia Zdrowia Psychicznego /ID# 234750
city: Kielce
country: Poland
facility: Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064
city: Leszno
country: Poland
facility: Nzop Mentis /Id# 235062
city: Lublin
country: Poland
facility: Centrum Medyczne Neuromedica /ID# 235615
city: Sosnowiec
country: Poland
facility: Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061
city: Torun
country: Poland
facility: Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001
city: Torun
country: Poland
facility: Osrodek Badan Klinicznych Clinsante /ID# 234990
city: Wroclaw
country: Poland
facility: Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007
city: San Juan
country: Puerto Rico
facility: INSPIRA Clinical Research /ID# 234542
city: Belgrade
country: Serbia
facility: Military Medical Academy /ID# 237062
state: Beograd
city: Belgrade
country: Serbia
facility: University Clinical Center Serbia /ID# 237747
state: Beograd
city: NIS
country: Serbia
facility: University Clinical Center of Nis /ID# 236973
state: Nisavski Okrug
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac /ID# 237750
state: Sumadijski Okrug
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac /ID# 237752
state: Sumadijski Okrug
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac /ID# 237753
state: Sumadijski Okrug
city: Belgrade
country: Serbia
facility: Bel Medic - General Hospital /ID# 236171
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 234299
city: Belgrade
country: Serbia
facility: Institute of Mental Health /ID# 236481
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Diseases Kovin /ID# 234691
city: Novi Knezevac
country: Serbia
facility: Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716
city: Vršac
country: Serbia
facility: Special Psychiatric Hospital /ID# 235152
city: Bratislava
country: Slovakia
facility: J&J SMART Ltd. /ID# 235902
city: Bratislava
country: Slovakia
facility: Psychiatrická ambulancia MENTUM /ID# 235020
city: Bratislava
country: Slovakia
facility: Vavrusova Consulting s.r.o. /ID# 235022
city: Kosice
country: Slovakia
facility: EPAMED s.r.o. /ID# 234830
city: Liptovsky Mikulas
country: Slovakia
facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 235216
city: Rimavska Sobota
country: Slovakia
facility: Psycholine s.r.o /ID# 235081
city: Svidnik
country: Slovakia
facility: Centrum zdravia R.B.K sro /ID# 235085
city: Vranov nad Toplou
country: Slovakia
facility: Crystal Comfort s.r.o. /ID# 235083
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: