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The Object 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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT03739203
Collaborator
(none)
753
Enrollment
113
Locations
3
Arms
33.9
Actual Duration (Months)
6.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
753 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone
Actual Study Start Date :
Nov 10, 2018
Actual Primary Completion Date :
Sep 6, 2021
Actual Study Completion Date :
Sep 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cariprazine 1.5 mg

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).

Drug: Cariprazine
Cariprazine supplied in capsules
Experimental: Cariprazine 3 mg

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).

Drug: Cariprazine
Cariprazine supplied in capsules
Placebo Comparator: 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).

Drug: Placebo
Placebo supplied in capsules

Outcome Measures

Primary Outcome Measures

  1. Total score change from baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) [6 Weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 18 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harmonex /ID# 236936 Dothan Alabama United States 36303
2 Woodland International Research Group /ID# 236349 Little Rock Arkansas United States 72211
3 California Pharmaceutical Research Institute /ID# 236731 Anaheim California United States 92804-3738
4 Axiom Research /ID# 236267 Colton California United States 92324
5 Global Clinical Trials /ID# 235059 Costa Mesa California United States 92627
6 Collaborative Neuroscience Research - Orange County /ID# 237637 Garden Grove California United States 92845
7 Behavioral Research Specialists, LLC /ID# 236622 Glendale California United States 91206-4261
8 Sun Valley Research Center /ID# 236560 Imperial California United States 92251-9401
9 North County Clinical Research /ID# 235014 Oceanside California United States 92054
10 Excell Research, Inc /ID# 237717 Oceanside California United States 92056
11 NRC Research Institute /ID# 234632 Orange California United States 92868
12 Anderson Clinical Research /ID# 236624 Redlands California United States 92374-4555
13 Syrentis Clinical Research /ID# 237408 Santa Ana California United States 92705
14 California Neuroscience Research Medical Group, Inc. /ID# 236636 Sherman Oaks California United States 91403-2109
15 Schuster Medical Research Institute /ID# 236445 Sherman Oaks California United States 91403
16 Pacific Clinical Research Management Group /ID# 234378 Upland California United States 91786-3676
17 MCB Clinical Research Centers /ID# 236927 Colorado Springs Colorado United States 80910
18 CT Clinical Research /ID# 234638 Cromwell Connecticut United States 06416
19 Innovative Clinical Research /ID# 235186 Fort Lauderdale Florida United States 33319
20 Gulf Coast Clinical Research Center /ID# 236280 Fort Myers Florida United States 33912
21 Innova Clinical Trials /ID# 237376 Miami Florida United States 33133
22 International Research Associates, LLC /ID# 237410 Miami Florida United States 33183
23 Medical Research Group of Central Florida /ID# 237326 Orange City Florida United States 32763
24 Clinical Neuroscience Solutions, Inc /ID# 236604 Orlando Florida United States 32801-2986
25 Space Coast Neuropsychiatric Research Institute /ID# 235766 Palm Bay Florida United States 32905
26 Atlanta Center for Medical Research /ID# 234696 Atlanta Georgia United States 30331
27 Institute for Advanced Medical Research /ID# 234992 Atlanta Georgia United States 30341
28 iResearch Savannah /ID# 236082 Savannah Georgia United States 31405
29 Iris Research Inc. /ID# 234995 Smyrna Georgia United States 30082-2629
30 AMR Conventions Research /ID# 236262 Naperville Illinois United States 60563
31 Collective Medical Research /ID# 236397 Prairie Village Kansas United States 66208
32 Boston Clinical Trials /ID# 236558 Boston Massachusetts United States 02131-2515
33 BTC of New Bedford /ID# 236381 New Bedford Massachusetts United States 02740
34 The Coastal Research Associates Inc /ID# 235056 South Weymouth Massachusetts United States 02190
35 Sisu at Renaissance Medical Group /ID# 236198 Springfield Massachusetts United States 01103
36 Center for Emotional Fitness /ID# 236630 Cherry Hill New Jersey United States 08002-3008
37 Bio Behavioral Health, Inc /ID# 238209 Toms River New Jersey United States 08755-6434
38 SPRI Clinical Trails /ID# 236657 Brooklyn New York United States 11235-5660
39 Bioscience Research /ID# 234961 Mount Kisco New York United States 10549-3028
40 Fieve Clinical Research, Inc. /ID# 236632 New York New York United States 10017-1921
41 Eastside Comprehensive Medical Center LLC /ID# 236094 New York New York United States 10128
42 Clinical Trials America /ID# 237636 Hickory North Carolina United States 28601
43 Quest Therapeutics of Avon Lake /ID# 236281 Avon Lake Ohio United States 44012
44 Patient Priority Clinical Sites, LLC /ID# 236743 Cincinnati Ohio United States 45215-2123
45 North Star Medical Research LL /ID# 235076 Middleburg Heights Ohio United States 44130
46 CincyScience /ID# 236387 West Chester Ohio United States 45069
47 Lynn Health Science Institute (LHSI) /ID# 237612 Oklahoma City Oklahoma United States 73112
48 Central States Research /ID# 238295 Tulsa Oklahoma United States 74136
49 Oregon Ctr for Clin Inv /ID# 237463 Salem Oregon United States 97301
50 Keystone Clinical Studies LLC /ID# 238153 Plymouth Meeting Pennsylvania United States 19462
51 Psychiatric Consultants PC /ID# 235838 Franklin Tennessee United States 37067
52 Research Strategies of Memphis /ID# 236629 Memphis Tennessee United States 38119-5202
53 Earle Research /ID# 236660 Houston Texas United States 77058-2746
54 AIM Trials /ID# 236366 Plano Texas United States 75093
55 Clinical Trials of Texas, Inc /ID# 237864 San Antonio Texas United States 78229
56 Family Psychiatry of The Woodlands /ID# 236423 The Woodlands Texas United States 77381
57 Woodstock Research Center /ID# 236653 Woodstock Vermont United States 05091-9795
58 SSM Health Dean Medical Group /ID# 238103 Madison Wisconsin United States 53715
59 Chatham-Kent Clinical Trials /ID# 235707 Chatham Ontario Canada N7L 1C1
60 Introspect Clinical Research Centre /ID# 235987 Ottawa Ontario Canada K1C 1T1
61 Recherches Neuro-Hippocampe Inc. d/b/a Ottawa Memory Clinic /ID# 235890 Ottawa Ontario Canada K1Z 1G3
62 Centre for Addiction and Mental Health /ID# 235936 Toronto Ontario Canada M6J 1H4
63 Diex Recherche Sherbrooke Inc. /ID# 234385 Sherbrooke Quebec Canada J1L 0H8
64 Medical Services Prague /ID# 235109 Praha 6 Praha, Hlavni Mesto Czechia 160 00
65 Saint Anne s.r.o. /ID# 235060 Brno Czechia 602 00
66 MUDr. Marta Holanova /ID# 235126 Brno Czechia 615 00
67 Neuropsychiatriehk s.r.o. /ID# 236195 Hradec Kralove Czechia 503 41
68 A-SHINE s.r.o. /ID# 236370 Plzen Czechia 323 00
69 CLINTRIAL s.r.o. /ID# 237794 Prague 10 Czechia 100 00
70 INEP medical s.r.o. /ID# 236291 Praha Czechia 186 00
71 Helsingin psykiatripalvelu /ID# 235090 Helsinki Finland 00260
72 Mederon Oy /ID# 235057 Helsinki Finland 00270
73 Savon Psykiatripalvelu Oy /ID# 235028 Kuopio Finland 70100
74 Oulu Mentalcare Oy /ID# 235089 Oulu Finland 90100
75 Satakunnan Psykiatripalvelu Oy /ID# 234936 Rauma Finland 26100
76 Psykiatri- ja psykologikeskus Mentoria /ID# 235091 Tampere Finland 33200
77 Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851 Belchatow Lodzkie Poland 97-400
78 Centrum Medyczne Luxmed /ID# 235110 Lublin Lubelskie Poland 20-109
79 Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 237466 Gdansk Pomorskie Poland 80-546
80 Zachodniopomorski Instytut Psychoterapii /ID# 236549 Szczecin Zachodniopomorskie Poland 70-486
81 Wlokiennicza Med /ID# 235105 Bia?ystok Poland 15-464
82 MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065 Bialystok Poland 15-404
83 Przychodnia Srodmiescie Sp. Z o.o. /ID# 236197 Bydgoszcz Poland 85-080
84 Med-Art /Id# 234986 Bydgoszcz Poland 85-156
85 Poradnia Zdrowia Psychicznego /ID# 234750 Chelmno Poland 86-200
86 Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064 Kielce Poland 25-411
87 Nzop Mentis /Id# 235062 Leszno Poland 64-100
88 Centrum Medyczne Neuromedica /ID# 235615 Lublin Poland 20-831
89 Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061 Sosnowiec Poland 41-200
90 Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001 Torun Poland 87-100
91 Osrodek Badan Klinicznych Clinsante /ID# 234990 Torun Poland 87-100
92 Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007 Wroclaw Poland 50-227
93 INSPIRA Clinical Research /ID# 234542 San Juan Puerto Rico 00918
94 Military Medical Academy /ID# 237062 Belgrade Beograd Serbia 11000
95 University Clinical Center Serbia /ID# 237747 Belgrade Beograd Serbia 11000
96 University Clinical Center of Nis /ID# 236973 NIS Nisavski Okrug Serbia 18000
97 University Clinical Center Kragujevac /ID# 237750 Kragujevac Sumadijski Okrug Serbia 34000
98 University Clinical Center Kragujevac /ID# 237752 Kragujevac Sumadijski Okrug Serbia 34000
99 University Clinical Center Kragujevac /ID# 237753 Kragujevac Sumadijski Okrug Serbia 34000
100 Bel Medic - General Hospital /ID# 236171 Belgrade Serbia 11000
101 Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 234299 Belgrade Serbia 11040
102 Institute of Mental Health /ID# 236481 Belgrade Serbia 11108
103 Special Hospital for Psychiatric Diseases Kovin /ID# 234691 Kovin Serbia 26220
104 Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716 Novi Knezevac Serbia 23330
105 Special Psychiatric Hospital /ID# 235152 Vršac Serbia 13000
106 J&J SMART Ltd. /ID# 235902 Bratislava Slovakia 811 07
107 Psychiatrická ambulancia MENTUM /ID# 235020 Bratislava Slovakia 820 07
108 Vavrusova Consulting s.r.o. /ID# 235022 Bratislava Slovakia 851 01
109 EPAMED s.r.o. /ID# 234830 Kosice Slovakia 040 01
110 Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 235216 Liptovsky Mikulas Slovakia 031 23
111 Psycholine s.r.o /ID# 235081 Rimavska Sobota Slovakia 979 01
112 Centrum zdravia R.B.K sro /ID# 235085 Svidnik Slovakia 089 01
113 Crystal Comfort s.r.o. /ID# 235083 Vranov nad Toplou Slovakia 093 01

Sponsors and Collaborators

  • AbbVie

Investigators

  • Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03739203
Other Study ID Numbers:
  • 3111-302-001
  • 2018-003164-31
First Posted:
Nov 13, 2018
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by AbbVie
MDD
Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Cariprazine

Study Results

No Results Posted as of Apr 12, 2022