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]).
- 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.
Sites / Locations
- Alea Research /ID# 234789
- Atria Clinical Research /ID# 237988
- Woodland Research Northwest, LLC /ID# 236641
- California Pharmaceutical Research Institute /ID# 236732
- Advanced Research Center /ID# 237957
- Axiom Research /ID# 236268
- ATP Clinical Research, Inc /ID# 236619
- ProScience Research Group /ID# 236442
- Collaborative Neuroscience Research - Orange County /ID# 237639
- Irvine Clinical Research /ID# 237409
- Omega Clinical Trials LLC /ID# 238168
- Synergy San Diego /ID# 236654
- Anderson Clinical Research /ID# 236627
- Sharp Mesa Vista Hospital /ID# 235797
- Viking Clinical Research /ID# 236614
- Olympian Clinical Research /ID# 237417
- MD Clinical
- Reliable Clinical Research /ID# 234786
- CNS Healthcare - Jacksonville /ID# 238241
- Space Coast Neuropsychiatric Research Institute /ID# 235765
- University of South Florida /ID# 234386
- Institute for Advanced Medical Research /ID# 236672
- iResearch Atlanta, LLC /ID# 237389
- Psych Atlanta /ID# 235835
- Capstone Clinical Research /ID# 236546
- Pillar Clinical Research /ID# 235702
- NeuroPsychiatric Research Practice & Associate LTD /ID# 234636
- Lake Charles Clinical Trials /ID# 237723
- J. Gary Booker MD APMC /ID# 234514
- Pharmasite Research, Inc. /ID# 237395
- CBH Health LLC /ID# 234536
- Michigan Clinical Research Institute /ID# 234792
- NeuroBehavioral Medicine Group /ID# 236671
- Precise Research Centers /ID# 236598
- Millennium Psychiatric Associates LLC /ID# 235989
- Alivation Research /ID# 236583
- Altea Research Institute /ID# 236726
- Hassman Research Institute /ID# 237501
- Integrative Clinical Trials /ID# 236656
- Manhattan Behavioral Medicine PLLC /ID# 236314
- Finger Lakes Clinical Research /ID# 236578
- New Hope Clinical Research Inc. /ID# 234557
- Richard Weisler MD, PA & Assoc /ID# 237424
- Quest Therapeutics of Avon Lake /ID# 236282
- CTI Clinical Trial and Consulting /ID# 236271
- The Ohio State University Department of Psychiatry /ID# 234583
- CincyScience /ID# 236391
- IPS Research Company /ID# 237671
- Sooner Clinical Research /ID# 236346
- Oregon Center for Clinical Investigations, Inc. - Portland /ID# 236649
- Lehigh Center for Clinical Research /ID# 236702
- Coastal Carolina Research Center /ID# 235909
- Psychiatric Consultants PC /ID# 235839
- Clinical Neuroscience Solutions - Memphis /ID# 237476
- Austin Clinical Trial Partners /ID# 236551
- BioBehavioral Research of Austin /ID# 236477
- Houston Clinical Trials /ID# 234442
- FutureSearch Trials of Dallas, LP /ID# 236275
- Earle Research /ID# 236661
- Red Oak Psychiatry Associates /ID# 236600
- AIM Trials /ID# 236369
- Pillar Clinical Research LLC /ID# 234465
- Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 236087
- Northwest Clinical Research Center /ID# 237584
- Core Clinical Research /ID# 236405
- UMHAT Alexandrovska EAD /ID# 237834
- State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 234625
- MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 234773
- UMHAT Dr Georgi Stranski EAD /ID# 237828
- Medical Center Mentalcare OOD /ID# 234934
- Clinic of Psychiatry /ID# 235878
- Mental health Centre-Ruse EOOD /ID# 234775
- Medical Center Sveti Naum EOOD /ID# 236069
- Medical Center Hera EOOD /ID# 235859
- Medical complex Doverie /ID# 238307
- Medical Centre - VAS OOD /ID# 235719
- Diagnostic consultative center Mladost M /ID# 236253
- Diagnostic consultative center Mladost M /ID# 236254
- Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo /ID# 236078
- Mental Health Center - Vratsa EOOD Hospital Pharmacy /ID# 235960
- Tartu University Hospital /ID# 237079
- West Tallinn Central Hospital /ID# 237078
- Marienthali Kliinik /ID# 235677
- OU Jaanson and Laane /ID# 234985
- Universitaetsklinikum Frankfurt /ID# 237292
- Private Practice - Dr. Thomsen /ID# 235713
- Emovis GmbH /ID# 235010
- MVZ LIO Berlin /ID# 235711
- BAG Prof. Dr. Kunte / Dr. sc. med. A. Schulze /ID# 235970
- Arztpraxis Dr Kirsten Hahn /ID# 235958
- Klinikum Chemnitz gGmbH /ID# 237758
- Studienzentrum Nord-West /ID# 236357
- Bacs-Kiskun Megyei Oktatokorhaz Szent-Kereszt Korhaz /ID# 235974
- PsychoTech Kft. /ID# 235008
- Bugat Pal Korhaz /ID# 238145
- Szent Borbala Korhaz /ID# 238293
- Obudai Egeszsegugyi Centrum Kft. /ID# 237495
- Clinexpert Kft /ID# 237266
- Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095
- Semmelweis Egyetem /ID# 237096
- Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912
- Varoskapu Rendelo - Processus Kft. /ID# 235170
- Cherkasy regional psychiatric hospital of the CRC /ID# 234513
- Geikivka multidisciplinary hospital for psychiatric care /ID# 234498
- KNP Prykarpatskyi Regional Clinical Centre of Mental Health /ID# 234999
- SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236336
- SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236338
- SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236340
- Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509
- Odesa regional psychiatric hospital 2 of the ORC /ID# 234505
- KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 234499
- KNP Kyiv City Psychoneurological Hospital /ID# 235093
- Kyiv Railway Clinical Hosp No.2 /ID# 237405
- CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 236270
- MNCE Odesa Regional Medical Center for Mental Health /ID# 235723
- Ternopil University Hospital /ID# 236819
- Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178
- Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179
- Knowle House Surgery /ID# 235025
- St. Peter's Hospital Surrey and Borders Partnership NHS FT /ID# 235725
- MAC Clinical Research /ID# 235938
- MAC Clinical Research /ID# 235941
- MAC Clinical Research /ID# 235945
- MAC Clinical Research /ID# 239078
- MAC Clinical Research-Manchester /ID# 235940
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Cariprazine 1.5 mg/Day + ADT
Cariprazine 3 mg/Day + ADT
Placebo + ADT
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).