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
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD
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.
Sites / Locations
- Harmonex /ID# 236936
- Woodland International Research Group /ID# 236349
- California Pharmaceutical Research Institute /ID# 236731
- Axiom Research /ID# 236267
- Global Clinical Trials /ID# 235059
- Collaborative Neuroscience Research - Orange County /ID# 237637
- Behavioral Research Specialists, LLC /ID# 236622
- Sun Valley Research Center /ID# 236560
- North County Clinical Research /ID# 235014
- Excell Research, Inc /ID# 237717
- NRC Research Institute /ID# 234632
- Anderson Clinical Research /ID# 236624
- Syrentis Clinical Research /ID# 237408
- California Neuroscience Research Medical Group, Inc. /ID# 236636
- Schuster Medical Research Institute /ID# 236445
- Pacific Clinical Research Management Group /ID# 234378
- MCB Clinical Research Centers /ID# 236927
- CT Clinical Research /ID# 234638
- Innovative Clinical Research /ID# 235186
- Gulfcoast Clinical Research Center /ID# 236280
- Innova Clinical Trials /ID# 237376
- International Research Associates, LLC /ID# 237410
- Medical Research Group of Central Florida /ID# 237326
- Clinical Neuroscience Solutions, Inc /ID# 236604
- Space Coast Neuropsychiatric Research Institute /ID# 235766
- Atlanta Center for Medical Research /ID# 234696
- Institute for Advanced Medical Research /ID# 234992
- iResearch Savannah /ID# 236082
- Iris Research Inc. /ID# 234995
- AMR Conventions Research /ID# 236262
- Collective Medical Research /ID# 236397
- Boston Clinical Trials /ID# 236558
- BTC of New Bedford /ID# 236381
- The Coastal Research Associates Inc /ID# 235056
- Sisu at Renaissance Medical Group /ID# 236198
- Center for Emotional Fitness /ID# 236630
- Bio Behavioral Health, Inc /ID# 238209
- SPRI Clinical Trails /ID# 236657
- Bioscience Research /ID# 234961
- Fieve Clinical Research, Inc. /ID# 236632
- Eastside Comprehensive Medical Center LLC /ID# 236094
- Clinical Trials America /ID# 237636
- Quest Therapeutics of Avon Lake /ID# 236281
- Patient Priority Clinical Sites, LLC /ID# 236743
- North Star Medical Research LL /ID# 235076
- CincyScience /ID# 236387
- Lynn Health Science Institute (LHSI) /ID# 237612
- Central States Research /ID# 238295
- Oregon Ctr for Clin Inv /ID# 237463
- Keystone Clinical Studies LLC /ID# 238153
- Psychiatric Consultants PC /ID# 235838
- Research Strategies of Memphis /ID# 236629
- Earle Research /ID# 236660
- AIM Trials /ID# 236366
- Clinical Trials of Texas, Inc /ID# 237864
- Family Psychiatry of The Woodlands /ID# 236423
- Woodstock Research Center /ID# 236653
- SSM Health Dean Medical Group /ID# 238103
- Chatham-Kent Clinical Trials /ID# 235707
- Introspect Clinical Research Centre /ID# 235987
- Recherches Neuro-Hippocampe Inc. d/b/a Ottawa Memory Clinic /ID# 235890
- Diex Recherche Sherbrooke Inc. /ID# 234385
- Medical Services Prague /ID# 235109
- Saint Anne s.r.o. /ID# 235060
- MUDr. Marta Holanova /ID# 235126
- Neuropsychiatriehk s.r.o. /ID# 236195
- A-SHINE s.r.o. /ID# 236370
- CLINTRIAL s.r.o. /ID# 237794
- INEP medical s.r.o. /ID# 236291
- Helsingin psykiatripalvelu /ID# 235090
- Mederon Oy /ID# 235057
- Savon Psykiatripalvelu Oy /ID# 235028
- Oulu Mentalcare Oy /ID# 235089
- Satakunnan Psykiatripalvelu Oy /ID# 234936
- Psykiatri- ja psykologikeskus Mentoria /ID# 235091
- Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851
- Centrum Medyczne Luxmed /ID# 235110
- Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 237466
- Zachodniopomorski Instytut Psychoterapii /ID# 236549
- Wlokiennicza Med /ID# 235105
- MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065
- Przychodnia Srodmiescie Sp. Z o.o. /ID# 236197
- Med-Art /Id# 234986
- Poradnia Zdrowia Psychicznego /ID# 234750
- Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064
- Nzop Mentis /Id# 235062
- Centrum Medyczne Neuromedica /ID# 235615
- Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061
- Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001
- Osrodek Badan Klinicznych Clinsante /ID# 234990
- Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007
- INSPIRA Clinical Research /ID# 234542
- Military Medical Academy /ID# 237062
- University Clinical Center Serbia /ID# 237747
- University Clinical Center of Nis /ID# 236973
- University Clinical Center Kragujevac /ID# 237750
- University Clinical Center Kragujevac /ID# 237752
- University Clinical Center Kragujevac /ID# 237753
- Bel Medic - General Hospital /ID# 236171
- Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 234299
- Institute of Mental Health /ID# 236481
- Special Hospital for Psychiatric Diseases Kovin /ID# 234691
- Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716
- Special Psychiatric Hospital /ID# 235152
- J&J SMART Ltd. /ID# 235902
- Psychiatrická ambulancia MENTUM /ID# 235020
- Vavrusova Consulting s.r.o. /ID# 235022
- EPAMED s.r.o. /ID# 234830
- Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 235216
- Psycholine s.r.o /ID# 235081
- Centrum zdravia R.B.K sro /ID# 235085
- Crystal Comfort s.r.o. /ID# 235083
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo + ADT
Cariprazine 1.5 mg/day + ADT
Cariprazine 3 mg/day + ADT
Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) [same antidepressant and dose of ADT they were on at the Baseline] during the Double-blind Treatment Period, up to Week 6.
Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.
Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.