Clinical trial NCT03738215: 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: 759
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 \[EU sites\]).
* Patient must be an outpatient at the time of Visit 1 (Screening).
* Patient meets the DSM-5 criteria for MDD based on 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.
* Patient demonstrates ability to follow study instructions and likely to complete all required visits.
* Patient must have an inadequate response, as measured by the modified 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 patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients 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 patients 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.
* Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.

Primary outcomes:
measure: Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale)
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: Phoenix
country: United States
facility: Alea Research /ID# 234789
state: Arizona
city: Little Rock
country: United States
facility: Atria Clinical Research /ID# 237988
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC /ID# 236641
state: Arkansas
city: Anaheim
country: United States
facility: California Pharmaceutical Research Institute /ID# 236732
state: California
city: Anaheim
country: United States
facility: Advanced Research Center /ID# 237957
state: California
city: Colton
country: United States
facility: Axiom Research /ID# 236268
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc /ID# 236619
state: California
city: Culver City
country: United States
facility: ProScience Research Group /ID# 236442
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research - Orange County /ID# 237639
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research /ID# 237409
state: California
city: La Habra
country: United States
facility: Omega Clinical Trials LLC /ID# 238168
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego /ID# 236654
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research /ID# 236627
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital /ID# 235797
state: California
city: Temecula
country: United States
facility: Viking Clinical Research /ID# 236614
state: California
city: Clearwater
country: United States
facility: Olympian Clinical Research /ID# 237417
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research /ID# 234786
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare - Jacksonville /ID# 238241
state: Florida
city: Palm Bay
country: United States
facility: Space Coast Neuropsychiatric Research Institute /ID# 235765
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 234386
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research /ID# 236672
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC /ID# 237389
state: Georgia
city: Marietta
country: United States
facility: Psych Atlanta /ID# 235835
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research /ID# 236546
state: Illinois
city: Lincolnwood
country: United States
facility: Pillar Clinical Research /ID# 235702
state: Illinois
city: Winfield
country: United States
facility: NeuroPsychiatric Research Practice & Associate LTD /ID# 234636
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials /ID# 237723
state: Louisiana
city: Shreveport
country: United States
facility: J. Gary Booker MD APMC /ID# 234514
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc. /ID# 237395
state: Maryland
city: Gaithersburg
country: United States
facility: CBH Health LLC /ID# 234536
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Institute /ID# 234792
state: Michigan
city: Bloomfield Hills
country: United States
facility: NeuroBehavioral Medicine Group /ID# 236671
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers /ID# 236598
state: Mississippi
city: Saint Louis
country: United States
facility: Millennium Psychiatric Associates LLC /ID# 235989
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research /ID# 236583
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research Institute /ID# 236726
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute /ID# 237501
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials /ID# 236656
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine PLLC /ID# 236314
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research /ID# 236578
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research Inc. /ID# 234557
state: North Carolina
city: Raleigh
country: United States
facility: Richard Weisler MD, PA & Assoc /ID# 237424
state: North Carolina
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake /ID# 236282
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting /ID# 236271
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Department of Psychiatry /ID# 234583
state: Ohio
city: West Chester
country: United States
facility: CincyScience /ID# 236391
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company /ID# 237671
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research /ID# 236346
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc. - Portland /ID# 236649
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research /ID# 236702
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center /ID# 235909
state: South Carolina
city: Franklin
country: United States
facility: Psychiatric Consultants PC /ID# 235839
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions - Memphis /ID# 237476
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Trial Partners /ID# 236551
state: Texas
city: Austin
country: United States
facility: BioBehavioral Research of Austin /ID# 236477
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials /ID# 234442
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP /ID# 236275
state: Texas
city: Friendswood
country: United States
facility: Earle Research /ID# 236661
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates /ID# 236600
state: Texas
city: Plano
country: United States
facility: AIM Trials /ID# 236369
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research LLC /ID# 234465
state: Texas
city: Woodstock
country: United States
facility: Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 236087
state: Vermont
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 237584
state: Washington
city: Everett
country: United States
facility: Core Clinical Research /ID# 236405
state: Washington
city: Sofiya
country: Bulgaria
facility: UMHAT Alexandrovska EAD /ID# 237834
state: Sofia
city: Kardzhali
country: Bulgaria
facility: State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 234625
city: Kazanlak
country: Bulgaria
facility: MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 234773
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 237828
city: Plovdiv
country: Bulgaria
facility: Medical Center Mentalcare OOD /ID# 234934
city: Plovdiv
country: Bulgaria
facility: Clinic of Psychiatry /ID# 235878
city: Ruse
country: Bulgaria
facility: Mental health Centre-Ruse EOOD /ID# 234775
city: Sofia
country: Bulgaria
facility: Medical Center Sveti Naum EOOD /ID# 236069
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD /ID# 235859
city: Sofia
country: Bulgaria
facility: Medical complex Doverie /ID# 238307
city: Targovishte
country: Bulgaria
facility: Medical Centre - VAS OOD /ID# 235719
city: Varna
country: Bulgaria
facility: Diagnostic consultative center Mladost M /ID# 236253
city: Varna
country: Bulgaria
facility: Diagnostic consultative center Mladost M /ID# 236254
city: Veliko Tarnovo
country: Bulgaria
facility: Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo /ID# 236078
city: Vratsa
country: Bulgaria
facility: Mental Health Center - Vratsa EOOD Hospital Pharmacy /ID# 235960
city: Tartu Linn
country: Estonia
facility: Tartu University Hospital /ID# 237079
state: Tartumaa
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital /ID# 237078
city: Tallinn
country: Estonia
facility: Marienthali Kliinik /ID# 235677
city: Tartu
country: Estonia
facility: OU Jaanson and Laane /ID# 234985
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 237292
state: Hessen
city: Berlin
country: Germany
facility: Private Practice - Dr. Thomsen /ID# 235713
city: Berlin
country: Germany
facility: Emovis GmbH /ID# 235010
city: Berlin
country: Germany
facility: MVZ LIO Berlin /ID# 235711
city: Berlin
country: Germany
facility: BAG Prof. Dr. Kunte / Dr. sc. med. A. Schulze /ID# 235970
city: Berlin
country: Germany
facility: Arztpraxis Dr Kirsten Hahn /ID# 235958
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH /ID# 237758
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West /ID# 236357
city: Kalocsa
country: Hungary
facility: Bacs-Kiskun Megyei Oktatokorhaz Szent-Kereszt Korhaz /ID# 235974
state: Bacs-Kiskun
city: Pecs
country: Hungary
facility: PsychoTech Kft. /ID# 235008
state: Baranya
city: Gyöngyös
country: Hungary
facility: Bugat Pal Korhaz /ID# 238145
state: Heves
city: Tatabanya
country: Hungary
facility: Szent Borbala Korhaz /ID# 238293
state: Komarom-Esztergom
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft. /ID# 237495
state: Pest
city: Budapest
country: Hungary
facility: Clinexpert Kft /ID# 237266
city: Budapest
country: Hungary
facility: Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 237096
city: Budapest
country: Hungary
facility: Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912
city: Budapest
country: Hungary
facility: Varoskapu Rendelo - Processus Kft. /ID# 235170
city: Smila
country: Ukraine
facility: Cherkasy regional psychiatric hospital of the CRC /ID# 234513
state: Cherkaska Oblast
city: Kryvbas Village
country: Ukraine
facility: Geikivka multidisciplinary hospital for psychiatric care /ID# 234498
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: KNP Prykarpatskyi Regional Clinical Centre of Mental Health /ID# 234999
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236336
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236338
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236340
state: Kharkivska Oblast
city: Stepanivka Village
country: Ukraine
facility: Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509
state: Khersonska Oblast
city: Oleksandrivka Village
country: Ukraine
facility: Odesa regional psychiatric hospital 2 of the ORC /ID# 234505
state: Odeska Oblast
city: Uzhgorod
country: Ukraine
facility: KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 234499
state: Zakarpatska Oblast
city: Kyiv
country: Ukraine
facility: KNP Kyiv City Psychoneurological Hospital /ID# 235093
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hosp No.2 /ID# 237405
city: Lviv
country: Ukraine
facility: CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 236270
city: Odesa
country: Ukraine
facility: MNCE Odesa Regional Medical Center for Mental Health /ID# 235723
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital /ID# 236819
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery /ID# 235025
state: Devon
city: Chertsey
country: United Kingdom
facility: St. Peter's Hospital Surrey and Borders Partnership NHS FT /ID# 235725
state: Surrey
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research /ID# 235938
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research /ID# 235941
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research /ID# 235945
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research /ID# 239078
city: Manchester
country: United Kingdom
facility: MAC Clinical Research-Manchester /ID# 235940
Study officials:
affiliation: AbbVie
name: Abbvie INC.
role: STUDY_DIRECTOR
References: