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
- Registration Number
- NCT03738215
- 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
- 759
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + ADT Placebo 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). Cariprazine 1.5 mg/Day + ADT Cariprazine 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 3 mg/Day + ADT Cariprazine 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).
- Primary Outcome Measures
Name Time Method Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Baseline and Week 6 The MADRS is a 10-item, clinician-rated scale that evaluates the patient's depressive symptomatology during the past week. Patients are 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 is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Number of subjects analyzed are the number of participants with data available 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 scores indicate worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses. mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Number of subjects analyzed are the number of participants with data available for analyses.
Trial Locations
- Locations (125)
Lehigh Center for Clinical Research /ID# 236702
🇺🇸Allentown, Pennsylvania, United States
Hassman Research Institute /ID# 237501
🇺🇸Berlin, New Jersey, United States
Psych Atlanta /ID# 235835
🇺🇸Marietta, Georgia, United States
Pharmasite Research, Inc. /ID# 237395
🇺🇸Baltimore, Maryland, United States
West Tallinn Central Hospital /ID# 237078
🇪🇪Tallinn, Estonia
KNP Kyiv City Psychoneurological Hospital /ID# 235093
🇺🇦Kyiv, Ukraine
Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178
🇺🇦Vinnytsia, Ukraine
Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179
🇺🇦Vinnytsia, Ukraine
Sharp Mesa Vista Hospital /ID# 235797
🇺🇸San Diego, California, United States
Altea Research Institute /ID# 236726
🇺🇸Las Vegas, Nevada, United States
CTI Clinical Trial and Consulting /ID# 236271
🇺🇸Cincinnati, Ohio, United States
Red Oak Psychiatry Associates /ID# 236600
🇺🇸Houston, Texas, United States
Alea Research /ID# 234789
🇺🇸Phoenix, Arizona, United States
IPS Research Company /ID# 237671
🇺🇸Oklahoma City, Oklahoma, United States
Axiom Research /ID# 236268
🇺🇸Colton, California, United States
ATP Clinical Research, Inc /ID# 236619
🇺🇸Costa Mesa, California, United States
Woodland Research Northwest, LLC /ID# 236641
🇺🇸Rogers, Arkansas, United States
Earle Research /ID# 236661
🇺🇸Friendswood, Texas, United States
CBH Health LLC /ID# 234536
🇺🇸Gaithersburg, Maryland, United States
Coastal Carolina Research Center /ID# 235909
🇺🇸North Charleston, South Carolina, United States
Clinic of Psychiatry /ID# 235878
🇧🇬Plovdiv, Bulgaria
FutureSearch Trials of Dallas, LP /ID# 236275
🇺🇸Dallas, Texas, United States
Psychiatric Consultants PC /ID# 235839
🇺🇸Franklin, Tennessee, United States
State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 234625
🇧🇬Kardzhali, Bulgaria
Pillar Clinical Research LLC /ID# 234465
🇺🇸Richardson, Texas, United States
Medical Center Sveti Naum EOOD /ID# 236069
🇧🇬Sofia, Bulgaria
UMHAT Alexandrovska EAD /ID# 237834
🇧🇬Sofiya, Sofia, Bulgaria
MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 234773
🇧🇬Kazanlak, Bulgaria
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 236087
🇺🇸Woodstock, Vermont, United States
Mental health Centre-Ruse EOOD /ID# 234775
🇧🇬Ruse, Bulgaria
Core Clinical Research /ID# 236405
🇺🇸Everett, Washington, United States
Medical Center Mentalcare OOD /ID# 234934
🇧🇬Plovdiv, Bulgaria
Medical Centre - VAS OOD /ID# 235719
🇧🇬Targovishte, Bulgaria
Diagnostic consultative center Mladost M /ID# 236253
🇧🇬Varna, Bulgaria
Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo /ID# 236078
🇧🇬Veliko Tarnovo, Bulgaria
Diagnostic consultative center Mladost M /ID# 236254
🇧🇬Varna, Bulgaria
Obudai Egeszsegugyi Centrum Kft. /ID# 237495
🇭🇺Budapest, Pest, Hungary
Klinikum Chemnitz gGmbH /ID# 237758
🇩🇪Chemnitz, Germany
Bugat Pal Korhaz /ID# 238145
🇭🇺Gyöngyös, Heves, Hungary
BAG Prof. Dr. Kunte / Dr. sc. med. A. Schulze /ID# 235970
🇩🇪Berlin, Germany
Szent Borbala Korhaz /ID# 238293
🇭🇺Tatabanya, Komarom-Esztergom, Hungary
Semmelweis Egyetem /ID# 237096
🇭🇺Budapest, Hungary
Cherkasy regional psychiatric hospital of the CRC /ID# 234513
🇺🇦Smila, Cherkaska Oblast, Ukraine
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236338
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236340
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509
🇺🇦Stepanivka Village, Khersonska Oblast, Ukraine
Kyiv Railway Clinical Hosp No.2 /ID# 237405
🇺🇦Kyiv, Ukraine
Knowle House Surgery /ID# 235025
🇬🇧Plymouth, Devon, United Kingdom
MAC Clinical Research /ID# 235938
🇬🇧Blackpool, United Kingdom
Oregon Center for Clinical Investigations, Inc. - Portland /ID# 236649
🇺🇸Portland, Oregon, United States
Private Practice - Dr. Thomsen /ID# 235713
🇩🇪Berlin, Germany
MVZ LIO Berlin /ID# 235711
🇩🇪Berlin, Germany
Houston Clinical Trials /ID# 234442
🇺🇸Bellaire, Texas, United States
Varoskapu Rendelo - Processus Kft. /ID# 235170
🇭🇺Budapest, Hungary
Precise Research Centers /ID# 236598
🇺🇸Flowood, Mississippi, United States
Atria Clinical Research /ID# 237988
🇺🇸Little Rock, Arkansas, United States
Advanced Research Center /ID# 237957
🇺🇸Anaheim, California, United States
California Pharmaceutical Research Institute /ID# 236732
🇺🇸Anaheim, California, United States
Collaborative Neuroscience Research - Orange County /ID# 237639
🇺🇸Garden Grove, California, United States
ProScience Research Group /ID# 236442
🇺🇸Culver City, California, United States
Synergy San Diego /ID# 236654
🇺🇸Lemon Grove, California, United States
Irvine Clinical Research /ID# 237409
🇺🇸Irvine, California, United States
Omega Clinical Trials LLC /ID# 238168
🇺🇸La Habra, California, United States
Olympian Clinical Research /ID# 237417
🇺🇸Clearwater, Florida, United States
Viking Clinical Research /ID# 236614
🇺🇸Temecula, California, United States
Space Coast Neuropsychiatric Research Institute /ID# 235765
🇺🇸Palm Bay, Florida, United States
Anderson Clinical Research /ID# 236627
🇺🇸Redlands, California, United States
Reliable Clinical Research /ID# 234786
🇺🇸Hialeah, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
CNS Healthcare - Jacksonville /ID# 238241
🇺🇸Jacksonville, Florida, United States
Institute for Advanced Medical Research /ID# 236672
🇺🇸Alpharetta, Georgia, United States
Capstone Clinical Research /ID# 236546
🇺🇸Libertyville, Illinois, United States
iResearch Atlanta, LLC /ID# 237389
🇺🇸Decatur, Georgia, United States
Pillar Clinical Research /ID# 235702
🇺🇸Lincolnwood, Illinois, United States
Lake Charles Clinical Trials /ID# 237723
🇺🇸Lake Charles, Louisiana, United States
NeuroPsychiatric Research Practice & Associate LTD /ID# 234636
🇺🇸Winfield, Illinois, United States
J. Gary Booker MD APMC /ID# 234514
🇺🇸Shreveport, Louisiana, United States
Millennium Psychiatric Associates LLC /ID# 235989
🇺🇸Saint Louis, Missouri, United States
Alivation Research /ID# 236583
🇺🇸Lincoln, Nebraska, United States
Integrative Clinical Trials /ID# 236656
🇺🇸Brooklyn, New York, United States
Manhattan Behavioral Medicine PLLC /ID# 236314
🇺🇸New York, New York, 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
Finger Lakes Clinical Research /ID# 236578
🇺🇸Rochester, New York, United States
The Ohio State University Department of Psychiatry /ID# 234583
🇺🇸Columbus, Ohio, United States
New Hope Clinical Research Inc. /ID# 234557
🇺🇸Charlotte, North Carolina, United States
CincyScience /ID# 236391
🇺🇸West Chester, Ohio, United States
Sooner Clinical Research /ID# 236346
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Neuroscience Solutions - Memphis /ID# 237476
🇺🇸Memphis, Tennessee, United States
AIM Trials /ID# 236369
🇺🇸Plano, Texas, United States
Northwest Clinical Research Center /ID# 237584
🇺🇸Bellevue, Washington, United States
UMHAT Dr Georgi Stranski EAD /ID# 237828
🇧🇬Pleven, Bulgaria
Medical Center Hera EOOD /ID# 235859
🇧🇬Sofia, Bulgaria
Medical complex Doverie /ID# 238307
🇧🇬Sofia, Bulgaria
Mental Health Center - Vratsa EOOD Hospital Pharmacy /ID# 235960
🇧🇬Vratsa, Bulgaria
OU Jaanson and Laane /ID# 234985
🇪🇪Tartu, Estonia
Marienthali Kliinik /ID# 235677
🇪🇪Tallinn, Estonia
Universitaetsklinikum Frankfurt /ID# 237292
🇩🇪Frankfurt am Main, Hessen, Germany
Emovis GmbH /ID# 235010
🇩🇪Berlin, Germany
PsychoTech Kft. /ID# 235008
🇭🇺Pecs, Baranya, Hungary
Studienzentrum Nord-West /ID# 236357
🇩🇪Westerstede, Germany
Bacs-Kiskun Megyei Oktatokorhaz Szent-Kereszt Korhaz /ID# 235974
🇭🇺Kalocsa, Bacs-Kiskun, Hungary
Clinexpert Kft /ID# 237266
🇭🇺Budapest, Hungary
Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095
🇭🇺Budapest, Hungary
Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912
🇭🇺Budapest, Hungary
KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 234499
🇺🇦Uzhgorod, Zakarpatska Oblast, Ukraine
MAC Clinical Research /ID# 235945
🇬🇧Blackpool, United Kingdom
MAC Clinical Research /ID# 235941
🇬🇧Blackpool, United Kingdom
MAC Clinical Research /ID# 239078
🇬🇧Blackpool, United Kingdom
MAC Clinical Research-Manchester /ID# 235940
🇬🇧Manchester, United Kingdom
Austin Clinical Trial Partners /ID# 236551
🇺🇸Austin, Texas, United States
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236336
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Tartu University Hospital /ID# 237079
🇪🇪Tartu Linn, Tartumaa, Estonia
Geikivka multidisciplinary hospital for psychiatric care /ID# 234498
🇺🇦Kryvbas Village, Dnipropetrovska Oblast, Ukraine
CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 236270
🇺🇦Lviv, Ukraine
Odesa regional psychiatric hospital 2 of the ORC /ID# 234505
🇺🇦Oleksandrivka Village, Odeska Oblast, Ukraine
MNCE Odesa Regional Medical Center for Mental Health /ID# 235723
🇺🇦Odesa, Ukraine
Ternopil University Hospital /ID# 236819
🇺🇦Ternopil, Ukraine
St. Peter's Hospital Surrey and Borders Partnership NHS FT /ID# 235725
🇬🇧Chertsey, Surrey, United Kingdom
University of South Florida /ID# 234386
🇺🇸Tampa, Florida, United States
Michigan Clinical Research Institute /ID# 234792
🇺🇸Ann Arbor, Michigan, United States
BioBehavioral Research of Austin /ID# 236477
🇺🇸Austin, Texas, United States
NeuroBehavioral Medicine Group /ID# 236671
🇺🇸Bloomfield Hills, Michigan, United States
KNP Prykarpatskyi Regional Clinical Centre of Mental Health /ID# 234999
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Arztpraxis Dr Kirsten Hahn /ID# 235958
🇩🇪Berlin, Germany