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
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT03739203
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + ADT Placebo 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/day + ADT Antidepressant Therapy (ADT) 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 3 mg/day + ADT Antidepressant Therapy (ADT) 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. Placebo + ADT Antidepressant Therapy (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 3 mg/day + ADT Cariprazine 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. Cariprazine 1.5 mg/day + ADT Cariprazine 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.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score Baseline and Week 6 The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for analyses.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score Baseline and Week 6 The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses.
Trial Locations
- Locations (112)
Global Clinical Trials /ID# 235059
🇺🇸Costa Mesa, California, United States
Institute for Advanced Medical Research /ID# 234992
🇺🇸Atlanta, Georgia, United States
International Research Associates, LLC /ID# 237410
🇺🇸Miami, Florida, United States
Harmonex /ID# 236936
🇺🇸Dothan, Alabama, United States
Sun Valley Research Center /ID# 236560
🇺🇸Imperial, California, United States
Collaborative Neuroscience Research - Orange County /ID# 237637
🇺🇸Garden Grove, California, United States
Syrentis Clinical Research /ID# 237408
🇺🇸Santa Ana, California, United States
AIM Trials /ID# 236366
🇺🇸Plano, Texas, United States
Schuster Medical Research Institute /ID# 236445
🇺🇸Sherman Oaks, California, United States
Medical Research Group of Central Florida /ID# 237326
🇺🇸Orange City, Florida, United States
CT Clinical Research /ID# 234638
🇺🇸Cromwell, Connecticut, United States
Gulfcoast Clinical Research Center /ID# 236280
🇺🇸Fort Myers, Florida, United States
Boston Clinical Trials /ID# 236558
🇺🇸Boston, Massachusetts, United States
Woodland International Research Group /ID# 236349
🇺🇸Little Rock, Arkansas, United States
Innovative Clinical Research /ID# 235186
🇺🇸Fort Lauderdale, Florida, United States
Space Coast Neuropsychiatric Research Institute /ID# 235766
🇺🇸Palm Bay, Florida, United States
Oulu Mentalcare Oy /ID# 235089
🇫🇮Oulu, Finland
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851
🇵🇱Belchatow, Lodzkie, Poland
BTC of New Bedford /ID# 236381
🇺🇸New Bedford, Massachusetts, United States
Woodstock Research Center /ID# 236653
🇺🇸Woodstock, Vermont, United States
The Coastal Research Associates Inc /ID# 235056
🇺🇸South Weymouth, Massachusetts, United States
Innova Clinical Trials /ID# 237376
🇺🇸Miami, Florida, United States
Mederon Oy /ID# 235057
🇫🇮Helsinki, Finland
Zachodniopomorski Instytut Psychoterapii /ID# 236549
🇵🇱Szczecin, Zachodniopomorskie, Poland
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065
🇵🇱Bialystok, Poland
Przychodnia Srodmiescie Sp. Z o.o. /ID# 236197
🇵🇱Bydgoszcz, Poland
Diex Recherche Sherbrooke Inc. /ID# 234385
🇨🇦Sherbrooke, Quebec, Canada
Recherches Neuro-Hippocampe Inc. d/b/a Ottawa Memory Clinic /ID# 235890
🇨🇦Ottawa, Ontario, Canada
Sisu at Renaissance Medical Group /ID# 236198
🇺🇸Springfield, Massachusetts, United States
Bio Behavioral Health, Inc /ID# 238209
🇺🇸Toms River, New Jersey, United States
Chatham-Kent Clinical Trials /ID# 235707
🇨🇦Chatham, Ontario, Canada
Helsingin psykiatripalvelu /ID# 235090
🇫🇮Helsinki, Finland
Nzop Mentis /Id# 235062
🇵🇱Leszno, Poland
Research Strategies of Memphis /ID# 236629
🇺🇸Memphis, Tennessee, United States
Institute of Mental Health /ID# 236481
🇷🇸Belgrade, Serbia
Special Hospital for Psychiatric Diseases Kovin /ID# 234691
🇷🇸Kovin, Serbia
Military Medical Academy /ID# 237062
🇷🇸Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 237747
🇷🇸Belgrade, Beograd, Serbia
Bel Medic - General Hospital /ID# 236171
🇷🇸Belgrade, Serbia
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 234299
🇷🇸Belgrade, Serbia
University Clinical Center of Nis /ID# 236973
🇷🇸NIS, Nisavski Okrug, Serbia
University Clinical Center Kragujevac /ID# 237750
🇷🇸Kragujevac, Sumadijski Okrug, Serbia
University Clinical Center Kragujevac /ID# 237752
🇷🇸Kragujevac, Sumadijski Okrug, Serbia
University Clinical Center Kragujevac /ID# 237753
🇷🇸Kragujevac, Sumadijski Okrug, Serbia
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716
🇷🇸Novi Knezevac, Serbia
Special Psychiatric Hospital /ID# 235152
🇷🇸Vršac, Serbia
J&J SMART Ltd. /ID# 235902
🇸🇰Bratislava, Slovakia
Psychiatrická ambulancia MENTUM /ID# 235020
🇸🇰Bratislava, Slovakia
Vavrusova Consulting s.r.o. /ID# 235022
🇸🇰Bratislava, Slovakia
EPAMED s.r.o. /ID# 234830
🇸🇰Kosice, Slovakia
Psycholine s.r.o /ID# 235081
🇸🇰Rimavska Sobota, Slovakia
Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 235216
🇸🇰Liptovsky Mikulas, Slovakia
Centrum zdravia R.B.K sro /ID# 235085
🇸🇰Svidnik, Slovakia
Crystal Comfort s.r.o. /ID# 235083
🇸🇰Vranov nad Toplou, Slovakia
A-SHINE s.r.o. /ID# 236370
🇨🇿Plzen, Czechia
Clinical Neuroscience Solutions, Inc /ID# 236604
🇺🇸Orlando, Florida, United States
Clinical Trials of Texas, Inc /ID# 237864
🇺🇸San Antonio, Texas, United States
Lynn Health Science Institute (LHSI) /ID# 237612
🇺🇸Oklahoma City, Oklahoma, United States
California Pharmaceutical Research Institute /ID# 236731
🇺🇸Anaheim, California, United States
Axiom Research /ID# 236267
🇺🇸Colton, California, United States
Excell Research, Inc /ID# 237717
🇺🇸Oceanside, California, United States
Behavioral Research Specialists, LLC /ID# 236622
🇺🇸Glendale, California, United States
North County Clinical Research /ID# 235014
🇺🇸Oceanside, California, United States
NRC Research Institute /ID# 234632
🇺🇸Orange, California, United States
MCB Clinical Research Centers /ID# 236927
🇺🇸Colorado Springs, Colorado, United States
California Neuroscience Research Medical Group, Inc. /ID# 236636
🇺🇸Sherman Oaks, California, United States
Anderson Clinical Research /ID# 236624
🇺🇸Redlands, California, United States
Atlanta Center for Medical Research /ID# 234696
🇺🇸Atlanta, Georgia, United States
iResearch Savannah /ID# 236082
🇺🇸Savannah, Georgia, United States
Iris Research Inc. /ID# 234995
🇺🇸Smyrna, Georgia, United States
AMR Conventions Research /ID# 236262
🇺🇸Naperville, Illinois, United States
Collective Medical Research /ID# 236397
🇺🇸Prairie Village, Kansas, United States
Bioscience Research /ID# 234961
🇺🇸Mount Kisco, New York, United States
Fieve Clinical Research, Inc. /ID# 236632
🇺🇸New York, New York, United States
Eastside Comprehensive Medical Center LLC /ID# 236094
🇺🇸New York, New York, United States
Patient Priority Clinical Sites, LLC /ID# 236743
🇺🇸Cincinnati, Ohio, United States
Clinical Trials America /ID# 237636
🇺🇸Hickory, North Carolina, United States
Quest Therapeutics of Avon Lake /ID# 236281
🇺🇸Avon Lake, Ohio, United States
North Star Medical Research LL /ID# 235076
🇺🇸Middleburg Heights, Ohio, United States
CincyScience /ID# 236387
🇺🇸West Chester, Ohio, United States
Psychiatric Consultants PC /ID# 235838
🇺🇸Franklin, Tennessee, United States
Keystone Clinical Studies LLC /ID# 238153
🇺🇸Plymouth Meeting, Pennsylvania, United States
Central States Research /ID# 238295
🇺🇸Tulsa, Oklahoma, United States
Oregon Ctr for Clin Inv /ID# 237463
🇺🇸Salem, Oregon, United States
Earle Research /ID# 236660
🇺🇸Friendswood, Texas, United States
Family Psychiatry of The Woodlands /ID# 236423
🇺🇸The Woodlands, Texas, United States
SSM Health Dean Medical Group /ID# 238103
🇺🇸Madison, Wisconsin, United States
Introspect Clinical Research Centre /ID# 235987
🇨🇦Ottawa, Ontario, Canada
MUDr. Marta Holanova /ID# 235126
🇨🇿Brno, Czechia
Medical Services Prague /ID# 235109
🇨🇿Praha 6, Praha, Hlavni Mesto, Czechia
Saint Anne s.r.o. /ID# 235060
🇨🇿Brno, Czechia
INEP medical s.r.o. /ID# 236291
🇨🇿Praha, Czechia
Neuropsychiatriehk s.r.o. /ID# 236195
🇨🇿Hradec Kralove, Czechia
CLINTRIAL s.r.o. /ID# 237794
🇨🇿Prague 10, Czechia
Savon Psykiatripalvelu Oy /ID# 235028
🇫🇮Kuopio, Finland
Satakunnan Psykiatripalvelu Oy /ID# 234936
🇫🇮Rauma, Finland
Psykiatri- ja psykologikeskus Mentoria /ID# 235091
🇫🇮Tampere, Finland
Centrum Medyczne Luxmed /ID# 235110
🇵🇱Lublin, Lubelskie, Poland
Wlokiennicza Med /ID# 235105
🇵🇱Bia?ystok, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 237466
🇵🇱Gdansk, Pomorskie, Poland
Med-Art /Id# 234986
🇵🇱Bydgoszcz, Poland
Poradnia Zdrowia Psychicznego /ID# 234750
🇵🇱Chelmno, Poland
Centrum Medyczne Neuromedica /ID# 235615
🇵🇱Lublin, Poland
Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064
🇵🇱Kielce, Poland
Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061
🇵🇱Sosnowiec, Poland
Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001
🇵🇱Torun, Poland
Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007
🇵🇱Wroclaw, Poland
Osrodek Badan Klinicznych Clinsante /ID# 234990
🇵🇱Torun, Poland
INSPIRA Clinical Research /ID# 234542
🇵🇷San Juan, Puerto Rico
SPRI Clinical Trails /ID# 236657
🇺🇸Brooklyn, New York, United States
Pacific Clinical Research Management Group /ID# 234378
🇺🇸Upland, California, United States
Center for Emotional Fitness /ID# 236630
🇺🇸Cherry Hill, New Jersey, United States