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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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Antidepressant Therapy (ADT)
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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]).
  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Harmonex /ID# 236936
  • Woodland International Research Group /ID# 236349
  • California Pharmaceutical Research Institute /ID# 236731
  • Axiom Research /ID# 236267
  • Global Clinical Trials /ID# 235059
  • Collaborative Neuroscience Research - Orange County /ID# 237637
  • Behavioral Research Specialists, LLC /ID# 236622
  • Sun Valley Research Center /ID# 236560
  • North County Clinical Research /ID# 235014
  • Excell Research, Inc /ID# 237717
  • NRC Research Institute /ID# 234632
  • Anderson Clinical Research /ID# 236624
  • Syrentis Clinical Research /ID# 237408
  • California Neuroscience Research Medical Group, Inc. /ID# 236636
  • Schuster Medical Research Institute /ID# 236445
  • Pacific Clinical Research Management Group /ID# 234378
  • MCB Clinical Research Centers /ID# 236927
  • CT Clinical Research /ID# 234638
  • Innovative Clinical Research /ID# 235186
  • Gulfcoast Clinical Research Center /ID# 236280
  • Innova Clinical Trials /ID# 237376
  • International Research Associates, LLC /ID# 237410
  • Medical Research Group of Central Florida /ID# 237326
  • Clinical Neuroscience Solutions, Inc /ID# 236604
  • Space Coast Neuropsychiatric Research Institute /ID# 235766
  • Atlanta Center for Medical Research /ID# 234696
  • Institute for Advanced Medical Research /ID# 234992
  • iResearch Savannah /ID# 236082
  • Iris Research Inc. /ID# 234995
  • AMR Conventions Research /ID# 236262
  • Collective Medical Research /ID# 236397
  • Boston Clinical Trials /ID# 236558
  • BTC of New Bedford /ID# 236381
  • The Coastal Research Associates Inc /ID# 235056
  • Sisu at Renaissance Medical Group /ID# 236198
  • Center for Emotional Fitness /ID# 236630
  • Bio Behavioral Health, Inc /ID# 238209
  • SPRI Clinical Trails /ID# 236657
  • Bioscience Research /ID# 234961
  • Fieve Clinical Research, Inc. /ID# 236632
  • Eastside Comprehensive Medical Center LLC /ID# 236094
  • Clinical Trials America /ID# 237636
  • Quest Therapeutics of Avon Lake /ID# 236281
  • Patient Priority Clinical Sites, LLC /ID# 236743
  • North Star Medical Research LL /ID# 235076
  • CincyScience /ID# 236387
  • Lynn Health Science Institute (LHSI) /ID# 237612
  • Central States Research /ID# 238295
  • Oregon Ctr for Clin Inv /ID# 237463
  • Keystone Clinical Studies LLC /ID# 238153
  • Psychiatric Consultants PC /ID# 235838
  • Research Strategies of Memphis /ID# 236629
  • Earle Research /ID# 236660
  • AIM Trials /ID# 236366
  • Clinical Trials of Texas, Inc /ID# 237864
  • Family Psychiatry of The Woodlands /ID# 236423
  • Woodstock Research Center /ID# 236653
  • SSM Health Dean Medical Group /ID# 238103
  • Chatham-Kent Clinical Trials /ID# 235707
  • Introspect Clinical Research Centre /ID# 235987
  • Recherches Neuro-Hippocampe Inc. d/b/a Ottawa Memory Clinic /ID# 235890
  • Diex Recherche Sherbrooke Inc. /ID# 234385
  • Medical Services Prague /ID# 235109
  • Saint Anne s.r.o. /ID# 235060
  • MUDr. Marta Holanova /ID# 235126
  • Neuropsychiatriehk s.r.o. /ID# 236195
  • A-SHINE s.r.o. /ID# 236370
  • CLINTRIAL s.r.o. /ID# 237794
  • INEP medical s.r.o. /ID# 236291
  • Helsingin psykiatripalvelu /ID# 235090
  • Mederon Oy /ID# 235057
  • Savon Psykiatripalvelu Oy /ID# 235028
  • Oulu Mentalcare Oy /ID# 235089
  • Satakunnan Psykiatripalvelu Oy /ID# 234936
  • Psykiatri- ja psykologikeskus Mentoria /ID# 235091
  • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851
  • Centrum Medyczne Luxmed /ID# 235110
  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 237466
  • Zachodniopomorski Instytut Psychoterapii /ID# 236549
  • Wlokiennicza Med /ID# 235105
  • MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065
  • Przychodnia Srodmiescie Sp. Z o.o. /ID# 236197
  • Med-Art /Id# 234986
  • Poradnia Zdrowia Psychicznego /ID# 234750
  • Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064
  • Nzop Mentis /Id# 235062
  • Centrum Medyczne Neuromedica /ID# 235615
  • Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061
  • Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001
  • Osrodek Badan Klinicznych Clinsante /ID# 234990
  • Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007
  • INSPIRA Clinical Research /ID# 234542
  • Military Medical Academy /ID# 237062
  • University Clinical Center Serbia /ID# 237747
  • University Clinical Center of Nis /ID# 236973
  • University Clinical Center Kragujevac /ID# 237750
  • University Clinical Center Kragujevac /ID# 237752
  • University Clinical Center Kragujevac /ID# 237753
  • Bel Medic - General Hospital /ID# 236171
  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 234299
  • Institute of Mental Health /ID# 236481
  • Special Hospital for Psychiatric Diseases Kovin /ID# 234691
  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716
  • Special Psychiatric Hospital /ID# 235152
  • J&J SMART Ltd. /ID# 235902
  • Psychiatrická ambulancia MENTUM /ID# 235020
  • Vavrusova Consulting s.r.o. /ID# 235022
  • EPAMED s.r.o. /ID# 234830
  • Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 235216
  • Psycholine s.r.o /ID# 235081
  • Centrum zdravia R.B.K sro /ID# 235085
  • Crystal Comfort s.r.o. /ID# 235083

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo + ADT

Cariprazine 1.5 mg/day + ADT

Cariprazine 3 mg/day + ADT

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score
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

Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score
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.

Full Information

First Posted
November 9, 2018
Last Updated
August 26, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03739203
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
September 6, 2021 (Actual)
Study Completion Date
September 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
752 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + ADT
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Cariprazine 1.5 mg/day + ADT
Arm Type
Experimental
Arm Description
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.
Arm Title
Cariprazine 3 mg/day + ADT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
VRAYLAR®
Intervention Description
Cariprazine supplied in capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo supplied in capsules
Intervention Type
Drug
Intervention Name(s)
Antidepressant Therapy (ADT)
Intervention Description
ADT as prescribed by the physician per standard of care in clinical practice.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score
Description
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.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score
Description
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.
Time Frame
Baseline and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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]). 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Harmonex /ID# 236936
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Woodland International Research Group /ID# 236349
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
California Pharmaceutical Research Institute /ID# 236731
City
Anaheim
State/Province
California
ZIP/Postal Code
92804-3738
Country
United States
Facility Name
Axiom Research /ID# 236267
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Global Clinical Trials /ID# 235059
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Collaborative Neuroscience Research - Orange County /ID# 237637
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Behavioral Research Specialists, LLC /ID# 236622
City
Glendale
State/Province
California
ZIP/Postal Code
91206-4261
Country
United States
Facility Name
Sun Valley Research Center /ID# 236560
City
Imperial
State/Province
California
ZIP/Postal Code
92251-9401
Country
United States
Facility Name
North County Clinical Research /ID# 235014
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
Country
United States
Facility Name
Excell Research, Inc /ID# 237717
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
NRC Research Institute /ID# 234632
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Anderson Clinical Research /ID# 236624
City
Redlands
State/Province
California
ZIP/Postal Code
92374-4555
Country
United States
Facility Name
Syrentis Clinical Research /ID# 237408
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc. /ID# 236636
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403-2109
Country
United States
Facility Name
Schuster Medical Research Institute /ID# 236445
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Pacific Clinical Research Management Group /ID# 234378
City
Upland
State/Province
California
ZIP/Postal Code
91786-3676
Country
United States
Facility Name
MCB Clinical Research Centers /ID# 236927
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
CT Clinical Research /ID# 234638
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Innovative Clinical Research /ID# 235186
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Gulfcoast Clinical Research Center /ID# 236280
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Innova Clinical Trials /ID# 237376
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
International Research Associates, LLC /ID# 237410
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Medical Research Group of Central Florida /ID# 237326
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc /ID# 236604
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801-2986
Country
United States
Facility Name
Space Coast Neuropsychiatric Research Institute /ID# 235766
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32905
Country
United States
Facility Name
Atlanta Center for Medical Research /ID# 234696
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Institute for Advanced Medical Research /ID# 234992
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
iResearch Savannah /ID# 236082
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Iris Research Inc. /ID# 234995
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30082-2629
Country
United States
Facility Name
AMR Conventions Research /ID# 236262
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Collective Medical Research /ID# 236397
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Boston Clinical Trials /ID# 236558
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131-2515
Country
United States
Facility Name
BTC of New Bedford /ID# 236381
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
The Coastal Research Associates Inc /ID# 235056
City
South Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Sisu at Renaissance Medical Group /ID# 236198
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Center for Emotional Fitness /ID# 236630
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002-3008
Country
United States
Facility Name
Bio Behavioral Health, Inc /ID# 238209
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755-6434
Country
United States
Facility Name
SPRI Clinical Trails /ID# 236657
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235-5660
Country
United States
Facility Name
Bioscience Research /ID# 234961
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549-3028
Country
United States
Facility Name
Fieve Clinical Research, Inc. /ID# 236632
City
New York
State/Province
New York
ZIP/Postal Code
10017-1921
Country
United States
Facility Name
Eastside Comprehensive Medical Center LLC /ID# 236094
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Clinical Trials America /ID# 237636
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Quest Therapeutics of Avon Lake /ID# 236281
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
Patient Priority Clinical Sites, LLC /ID# 236743
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215-2123
Country
United States
Facility Name
North Star Medical Research LL /ID# 235076
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
CincyScience /ID# 236387
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Lynn Health Science Institute (LHSI) /ID# 237612
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Central States Research /ID# 238295
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Oregon Ctr for Clin Inv /ID# 237463
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Keystone Clinical Studies LLC /ID# 238153
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Psychiatric Consultants PC /ID# 235838
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Research Strategies of Memphis /ID# 236629
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-5202
Country
United States
Facility Name
Earle Research /ID# 236660
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
AIM Trials /ID# 236366
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Clinical Trials of Texas, Inc /ID# 237864
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Family Psychiatry of The Woodlands /ID# 236423
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Woodstock Research Center /ID# 236653
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091-9795
Country
United States
Facility Name
SSM Health Dean Medical Group /ID# 238103
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Chatham-Kent Clinical Trials /ID# 235707
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 1C1
Country
Canada
Facility Name
Introspect Clinical Research Centre /ID# 235987
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1C 1T1
Country
Canada
Facility Name
Recherches Neuro-Hippocampe Inc. d/b/a Ottawa Memory Clinic /ID# 235890
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 1G3
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc. /ID# 234385
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Medical Services Prague /ID# 235109
City
Praha 6
State/Province
Praha, Hlavni Mesto
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Saint Anne s.r.o. /ID# 235060
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
MUDr. Marta Holanova /ID# 235126
City
Brno
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
Neuropsychiatriehk s.r.o. /ID# 236195
City
Hradec Kralove
ZIP/Postal Code
503 41
Country
Czechia
Facility Name
A-SHINE s.r.o. /ID# 236370
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
CLINTRIAL s.r.o. /ID# 237794
City
Prague 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
INEP medical s.r.o. /ID# 236291
City
Praha
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
Helsingin psykiatripalvelu /ID# 235090
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Mederon Oy /ID# 235057
City
Helsinki
ZIP/Postal Code
00270
Country
Finland
Facility Name
Savon Psykiatripalvelu Oy /ID# 235028
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Oulu Mentalcare Oy /ID# 235089
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Satakunnan Psykiatripalvelu Oy /ID# 234936
City
Rauma
ZIP/Postal Code
26100
Country
Finland
Facility Name
Psykiatri- ja psykologikeskus Mentoria /ID# 235091
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski /ID# 234851
City
Belchatow
State/Province
Lodzkie
ZIP/Postal Code
97-400
Country
Poland
Facility Name
Centrum Medyczne Luxmed /ID# 235110
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-109
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 237466
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Zachodniopomorski Instytut Psychoterapii /ID# 236549
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-486
Country
Poland
Facility Name
Wlokiennicza Med /ID# 235105
City
Bia?ystok
ZIP/Postal Code
15-464
Country
Poland
Facility Name
MlynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk /ID# 235065
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Przychodnia Srodmiescie Sp. Z o.o. /ID# 236197
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Facility Name
Med-Art /Id# 234986
City
Bydgoszcz
ZIP/Postal Code
85-156
Country
Poland
Facility Name
Poradnia Zdrowia Psychicznego /ID# 234750
City
Chelmno
ZIP/Postal Code
86-200
Country
Poland
Facility Name
Centrum Zdrowia Psychicznego BioMed - Jan Latala /ID# 235064
City
Kielce
ZIP/Postal Code
25-411
Country
Poland
Facility Name
Nzop Mentis /Id# 235062
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
Centrum Medyczne Neuromedica /ID# 235615
City
Lublin
ZIP/Postal Code
20-831
Country
Poland
Facility Name
Krzysztof Klinke Prywatny Gabinet Psychiatryczny /ID# 235061
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Gabinet Lekarski Torunskie Centrum Psychiatrii Neuromed /ID# 235001
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Osrodek Badan Klinicznych Clinsante /ID# 234990
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Przychodnia Lekarsko-Psychologiczna PERSONA /ID# 235007
City
Wroclaw
ZIP/Postal Code
50-227
Country
Poland
Facility Name
INSPIRA Clinical Research /ID# 234542
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Military Medical Academy /ID# 237062
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Serbia /ID# 237747
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Nis /ID# 236973
City
NIS
State/Province
Nisavski Okrug
ZIP/Postal Code
18000
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 237750
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 237752
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
University Clinical Center Kragujevac /ID# 237753
City
Kragujevac
State/Province
Sumadijski Okrug
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Bel Medic - General Hospital /ID# 236171
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 234299
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Institute of Mental Health /ID# 236481
City
Belgrade
ZIP/Postal Code
11108
Country
Serbia
Facility Name
Special Hospital for Psychiatric Diseases Kovin /ID# 234691
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Facility Name
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 234716
City
Novi Knezevac
ZIP/Postal Code
23330
Country
Serbia
Facility Name
Special Psychiatric Hospital /ID# 235152
City
Vršac
ZIP/Postal Code
13000
Country
Serbia
Facility Name
J&J SMART Ltd. /ID# 235902
City
Bratislava
ZIP/Postal Code
811 07
Country
Slovakia
Facility Name
Psychiatrická ambulancia MENTUM /ID# 235020
City
Bratislava
ZIP/Postal Code
820 07
Country
Slovakia
Facility Name
Vavrusova Consulting s.r.o. /ID# 235022
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
EPAMED s.r.o. /ID# 234830
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 235216
City
Liptovsky Mikulas
ZIP/Postal Code
031 23
Country
Slovakia
Facility Name
Psycholine s.r.o /ID# 235081
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Centrum zdravia R.B.K sro /ID# 235085
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Crystal Comfort s.r.o. /ID# 235083
City
Vranov nad Toplou
ZIP/Postal Code
093 01
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://rxabbvie.com
Description
VRAYLAR® (cariprazine) capsules prescribing information.

Learn more about this trial

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

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