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
NCT ID: NCT03738215
Last Updated: 2022-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
759 participants
INTERVENTIONAL
2018-11-09
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cariprazine 1.5 mg/Day + 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).
Cariprazine
Cariprazine supplied in capsules
Cariprazine 3 mg/Day + ADT
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).
Cariprazine
Cariprazine supplied in capsules
Placebo + ADT
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).
Placebo
Placebo supplied in capsules
Interventions
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Cariprazine
Cariprazine supplied in capsules
Placebo
Placebo supplied in capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Abbvie INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Alea Research /ID# 234789
Phoenix, Arizona, United States
Atria Clinical Research /ID# 237988
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC /ID# 236641
Rogers, Arkansas, United States
California Pharmaceutical Research Institute /ID# 236732
Anaheim, California, United States
Advanced Research Center /ID# 237957
Anaheim, California, United States
Axiom Research /ID# 236268
Colton, California, United States
ATP Clinical Research, Inc /ID# 236619
Costa Mesa, California, United States
ProScience Research Group /ID# 236442
Culver City, California, United States
Collaborative Neuroscience Research - Orange County /ID# 237639
Garden Grove, California, United States
Irvine Clinical Research /ID# 237409
Irvine, California, United States
Omega Clinical Trials LLC /ID# 238168
La Habra, California, United States
Synergy San Diego /ID# 236654
Lemon Grove, California, United States
Anderson Clinical Research /ID# 236627
Redlands, California, United States
Sharp Mesa Vista Hospital /ID# 235797
San Diego, California, United States
Viking Clinical Research /ID# 236614
Temecula, California, United States
Olympian Clinical Research /ID# 237417
Clearwater, Florida, United States
MD Clinical
Hallandale, Florida, United States
Reliable Clinical Research /ID# 234786
Hialeah, Florida, United States
CNS Healthcare - Jacksonville /ID# 238241
Jacksonville, Florida, United States
Space Coast Neuropsychiatric Research Institute /ID# 235765
Palm Bay, Florida, United States
University of South Florida /ID# 234386
Tampa, Florida, United States
Institute for Advanced Medical Research /ID# 236672
Alpharetta, Georgia, United States
iResearch Atlanta, LLC /ID# 237389
Decatur, Georgia, United States
Psych Atlanta /ID# 235835
Marietta, Georgia, United States
Capstone Clinical Research /ID# 236546
Libertyville, Illinois, United States
Pillar Clinical Research /ID# 235702
Lincolnwood, Illinois, United States
NeuroPsychiatric Research Practice & Associate LTD /ID# 234636
Winfield, Illinois, United States
Lake Charles Clinical Trials /ID# 237723
Lake Charles, Louisiana, United States
J. Gary Booker MD APMC /ID# 234514
Shreveport, Louisiana, United States
Pharmasite Research, Inc. /ID# 237395
Baltimore, Maryland, United States
CBH Health LLC /ID# 234536
Gaithersburg, Maryland, United States
Michigan Clinical Research Institute /ID# 234792
Ann Arbor, Michigan, United States
NeuroBehavioral Medicine Group /ID# 236671
Bloomfield Hills, Michigan, United States
Precise Research Centers /ID# 236598
Flowood, Mississippi, United States
Millennium Psychiatric Associates LLC /ID# 235989
St Louis, Missouri, United States
Alivation Research /ID# 236583
Lincoln, Nebraska, United States
Altea Research Institute /ID# 236726
Las Vegas, Nevada, United States
Hassman Research Institute /ID# 237501
Berlin, New Jersey, United States
Integrative Clinical Trials /ID# 236656
Brooklyn, New York, United States
Manhattan Behavioral Medicine PLLC /ID# 236314
New York, New York, United States
Finger Lakes Clinical Research /ID# 236578
Rochester, New York, United States
New Hope Clinical Research Inc. /ID# 234557
Charlotte, North Carolina, United States
Richard Weisler MD, PA & Assoc /ID# 237424
Raleigh, North Carolina, United States
Quest Therapeutics of Avon Lake /ID# 236282
Avon Lake, Ohio, United States
CTI Clinical Trial and Consulting /ID# 236271
Cincinnati, Ohio, United States
The Ohio State University Department of Psychiatry /ID# 234583
Columbus, Ohio, United States
CincyScience /ID# 236391
West Chester, Ohio, United States
IPS Research Company /ID# 237671
Oklahoma City, Oklahoma, United States
Sooner Clinical Research /ID# 236346
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc. - Portland /ID# 236649
Portland, Oregon, United States
Lehigh Center for Clinical Research /ID# 236702
Allentown, Pennsylvania, United States
Coastal Carolina Research Center /ID# 235909
North Charleston, South Carolina, United States
Psychiatric Consultants PC /ID# 235839
Franklin, Tennessee, United States
Clinical Neuroscience Solutions - Memphis /ID# 237476
Memphis, Tennessee, United States
Austin Clinical Trial Partners /ID# 236551
Austin, Texas, United States
BioBehavioral Research of Austin /ID# 236477
Austin, Texas, United States
Houston Clinical Trials /ID# 234442
Bellaire, Texas, United States
FutureSearch Trials of Dallas, LP /ID# 236275
Dallas, Texas, United States
Earle Research /ID# 236661
Friendswood, Texas, United States
Red Oak Psychiatry Associates /ID# 236600
Houston, Texas, United States
AIM Trials /ID# 236369
Plano, Texas, United States
Pillar Clinical Research LLC /ID# 234465
Richardson, Texas, United States
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 236087
Woodstock, Vermont, United States
Northwest Clinical Research Center /ID# 237584
Bellevue, Washington, United States
Core Clinical Research /ID# 236405
Everett, Washington, United States
UMHAT Alexandrovska EAD /ID# 237834
Sofiya, Sofia, Bulgaria
State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 234625
Kardzhali, , Bulgaria
MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 234773
Kazanlak, , Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 237828
Pleven, , Bulgaria
Medical Center Mentalcare OOD /ID# 234934
Plovdiv, , Bulgaria
Clinic of Psychiatry /ID# 235878
Plovdiv, , Bulgaria
Mental health Centre-Ruse EOOD /ID# 234775
Rousse, , Bulgaria
Medical Center Sveti Naum EOOD /ID# 236069
Sofia, , Bulgaria
Medical Center Hera EOOD /ID# 235859
Sofia, , Bulgaria
Medical complex Doverie /ID# 238307
Sofia, , Bulgaria
Medical Centre - VAS OOD /ID# 235719
Targovishte, , Bulgaria
Diagnostic consultative center Mladost M /ID# 236253
Varna, , Bulgaria
Diagnostic consultative center Mladost M /ID# 236254
Varna, , Bulgaria
Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo /ID# 236078
Veliko Tarnovo, , Bulgaria
Mental Health Center - Vratsa EOOD Hospital Pharmacy /ID# 235960
Vratsa, , Bulgaria
Tartu University Hospital /ID# 237079
Tartu, Tartu, Estonia
West Tallinn Central Hospital /ID# 237078
Tallinn, , Estonia
Marienthali Kliinik /ID# 235677
Tallinn, , Estonia
OU Jaanson and Laane /ID# 234985
Tartu, , Estonia
Universitaetsklinikum Frankfurt /ID# 237292
Frankfurt am Main, Hesse, Germany
Private Practice - Dr. Thomsen /ID# 235713
Berlin, , Germany
Emovis GmbH /ID# 235010
Berlin, , Germany
MVZ LIO Berlin /ID# 235711
Berlin, , Germany
BAG Prof. Dr. Kunte / Dr. sc. med. A. Schulze /ID# 235970
Berlin, , Germany
Arztpraxis Dr Kirsten Hahn /ID# 235958
Berlin, , Germany
Klinikum Chemnitz gGmbH /ID# 237758
Chemnitz, , Germany
Studienzentrum Nord-West /ID# 236357
Westerstede, , Germany
PsychoTech Kft. /ID# 235008
Pécs, Baranya, Hungary
Bacs-Kiskun Megyei Oktatokorhaz Szent-Kereszt Korhaz /ID# 235974
Kalocsa, Bács-Kiskun county, Hungary
Bugat Pal Korhaz /ID# 238145
Gyöngyös, Heves County, Hungary
Szent Borbala Korhaz /ID# 238293
Tatabánya, Komárom-Esztergom, Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 237495
Budapest, Pest County, Hungary
Clinexpert Kft /ID# 237266
Budapest, , Hungary
Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095
Budapest, , Hungary
Semmelweis Egyetem /ID# 237096
Budapest, , Hungary
Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912
Budapest, , Hungary
Varoskapu Rendelo - Processus Kft. /ID# 235170
Budapest, , Hungary
Cherkasy regional psychiatric hospital of the CRC /ID# 234513
Smila, Cherkasy Oblast, Ukraine
Geikivka multidisciplinary hospital for psychiatric care /ID# 234498
Kryvbas Village, Dnipropetrovsk Oblast, Ukraine
KNP Prykarpatskyi Regional Clinical Centre of Mental Health /ID# 234999
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236336
Kharkiv, Kharkivs’ka Oblast’, Ukraine
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236338
Kharkiv, Kharkivs’ka Oblast’, Ukraine
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236340
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509
Stepanivka Village, Kherson Oblast, Ukraine
Odesa regional psychiatric hospital 2 of the ORC /ID# 234505
Oleksandrivka Village, Odesa Oblast, Ukraine
KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 234499
Uzhhorod, Zakarpattia Oblast, Ukraine
KNP Kyiv City Psychoneurological Hospital /ID# 235093
Kyiv, , Ukraine
Kyiv Railway Clinical Hosp No.2 /ID# 237405
Kyiv, , Ukraine
CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 236270
Lviv, , Ukraine
MNCE Odesa Regional Medical Center for Mental Health /ID# 235723
Odesa, , Ukraine
Ternopil University Hospital /ID# 236819
Ternopil, , Ukraine
Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178
Vinnytsia, , Ukraine
Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179
Vinnytsia, , Ukraine
Knowle House Surgery /ID# 235025
Plymouth, Devon, United Kingdom
St. Peter's Hospital Surrey and Borders Partnership NHS FT /ID# 235725
Chertsey, Surrey, United Kingdom
MAC Clinical Research /ID# 235938
Blackpool, , United Kingdom
MAC Clinical Research /ID# 235941
Blackpool, , United Kingdom
MAC Clinical Research /ID# 235945
Blackpool, , United Kingdom
MAC Clinical Research /ID# 239078
Blackpool, , United Kingdom
MAC Clinical Research-Manchester /ID# 235940
Manchester, , United Kingdom
Countries
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References
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Sachs GS, Yeung PP, Rekeda L, Khan A, Adams JL, Fava M. Adjunctive Cariprazine for the Treatment of Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Am J Psychiatry. 2023 Mar 1;180(3):241-251. doi: 10.1176/appi.ajp.20220504. Epub 2023 Feb 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002782-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3111-301-001
Identifier Type: -
Identifier Source: org_study_id
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