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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
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]).
  • 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:

  • 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.

Sites / Locations

  • Alea Research /ID# 234789
  • Atria Clinical Research /ID# 237988
  • Woodland Research Northwest, LLC /ID# 236641
  • California Pharmaceutical Research Institute /ID# 236732
  • Advanced Research Center /ID# 237957
  • Axiom Research /ID# 236268
  • ATP Clinical Research, Inc /ID# 236619
  • ProScience Research Group /ID# 236442
  • Collaborative Neuroscience Research - Orange County /ID# 237639
  • Irvine Clinical Research /ID# 237409
  • Omega Clinical Trials LLC /ID# 238168
  • Synergy San Diego /ID# 236654
  • Anderson Clinical Research /ID# 236627
  • Sharp Mesa Vista Hospital /ID# 235797
  • Viking Clinical Research /ID# 236614
  • Olympian Clinical Research /ID# 237417
  • MD Clinical
  • Reliable Clinical Research /ID# 234786
  • CNS Healthcare - Jacksonville /ID# 238241
  • Space Coast Neuropsychiatric Research Institute /ID# 235765
  • University of South Florida /ID# 234386
  • Institute for Advanced Medical Research /ID# 236672
  • iResearch Atlanta, LLC /ID# 237389
  • Psych Atlanta /ID# 235835
  • Capstone Clinical Research /ID# 236546
  • Pillar Clinical Research /ID# 235702
  • NeuroPsychiatric Research Practice & Associate LTD /ID# 234636
  • Lake Charles Clinical Trials /ID# 237723
  • J. Gary Booker MD APMC /ID# 234514
  • Pharmasite Research, Inc. /ID# 237395
  • CBH Health LLC /ID# 234536
  • Michigan Clinical Research Institute /ID# 234792
  • NeuroBehavioral Medicine Group /ID# 236671
  • Precise Research Centers /ID# 236598
  • Millennium Psychiatric Associates LLC /ID# 235989
  • Alivation Research /ID# 236583
  • Altea Research Institute /ID# 236726
  • Hassman Research Institute /ID# 237501
  • Integrative Clinical Trials /ID# 236656
  • Manhattan Behavioral Medicine PLLC /ID# 236314
  • Finger Lakes Clinical Research /ID# 236578
  • New Hope Clinical Research Inc. /ID# 234557
  • Richard Weisler MD, PA & Assoc /ID# 237424
  • Quest Therapeutics of Avon Lake /ID# 236282
  • CTI Clinical Trial and Consulting /ID# 236271
  • The Ohio State University Department of Psychiatry /ID# 234583
  • CincyScience /ID# 236391
  • IPS Research Company /ID# 237671
  • Sooner Clinical Research /ID# 236346
  • Oregon Center for Clinical Investigations, Inc. - Portland /ID# 236649
  • Lehigh Center for Clinical Research /ID# 236702
  • Coastal Carolina Research Center /ID# 235909
  • Psychiatric Consultants PC /ID# 235839
  • Clinical Neuroscience Solutions - Memphis /ID# 237476
  • Austin Clinical Trial Partners /ID# 236551
  • BioBehavioral Research of Austin /ID# 236477
  • Houston Clinical Trials /ID# 234442
  • FutureSearch Trials of Dallas, LP /ID# 236275
  • Earle Research /ID# 236661
  • Red Oak Psychiatry Associates /ID# 236600
  • AIM Trials /ID# 236369
  • Pillar Clinical Research LLC /ID# 234465
  • Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 236087
  • Northwest Clinical Research Center /ID# 237584
  • Core Clinical Research /ID# 236405
  • UMHAT Alexandrovska EAD /ID# 237834
  • State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 234625
  • MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 234773
  • UMHAT Dr Georgi Stranski EAD /ID# 237828
  • Medical Center Mentalcare OOD /ID# 234934
  • Clinic of Psychiatry /ID# 235878
  • Mental health Centre-Ruse EOOD /ID# 234775
  • Medical Center Sveti Naum EOOD /ID# 236069
  • Medical Center Hera EOOD /ID# 235859
  • Medical complex Doverie /ID# 238307
  • Medical Centre - VAS OOD /ID# 235719
  • Diagnostic consultative center Mladost M /ID# 236253
  • Diagnostic consultative center Mladost M /ID# 236254
  • Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo /ID# 236078
  • Mental Health Center - Vratsa EOOD Hospital Pharmacy /ID# 235960
  • Tartu University Hospital /ID# 237079
  • West Tallinn Central Hospital /ID# 237078
  • Marienthali Kliinik /ID# 235677
  • OU Jaanson and Laane /ID# 234985
  • Universitaetsklinikum Frankfurt /ID# 237292
  • Private Practice - Dr. Thomsen /ID# 235713
  • Emovis GmbH /ID# 235010
  • MVZ LIO Berlin /ID# 235711
  • BAG Prof. Dr. Kunte / Dr. sc. med. A. Schulze /ID# 235970
  • Arztpraxis Dr Kirsten Hahn /ID# 235958
  • Klinikum Chemnitz gGmbH /ID# 237758
  • Studienzentrum Nord-West /ID# 236357
  • Bacs-Kiskun Megyei Oktatokorhaz Szent-Kereszt Korhaz /ID# 235974
  • PsychoTech Kft. /ID# 235008
  • Bugat Pal Korhaz /ID# 238145
  • Szent Borbala Korhaz /ID# 238293
  • Obudai Egeszsegugyi Centrum Kft. /ID# 237495
  • Clinexpert Kft /ID# 237266
  • Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095
  • Semmelweis Egyetem /ID# 237096
  • Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912
  • Varoskapu Rendelo - Processus Kft. /ID# 235170
  • Cherkasy regional psychiatric hospital of the CRC /ID# 234513
  • Geikivka multidisciplinary hospital for psychiatric care /ID# 234498
  • KNP Prykarpatskyi Regional Clinical Centre of Mental Health /ID# 234999
  • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236336
  • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236338
  • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236340
  • Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509
  • Odesa regional psychiatric hospital 2 of the ORC /ID# 234505
  • KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 234499
  • KNP Kyiv City Psychoneurological Hospital /ID# 235093
  • Kyiv Railway Clinical Hosp No.2 /ID# 237405
  • CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 236270
  • MNCE Odesa Regional Medical Center for Mental Health /ID# 235723
  • Ternopil University Hospital /ID# 236819
  • Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178
  • Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179
  • Knowle House Surgery /ID# 235025
  • St. Peter's Hospital Surrey and Borders Partnership NHS FT /ID# 235725
  • MAC Clinical Research /ID# 235938
  • MAC Clinical Research /ID# 235941
  • MAC Clinical Research /ID# 235945
  • MAC Clinical Research /ID# 239078
  • MAC Clinical Research-Manchester /ID# 235940

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cariprazine 1.5 mg/Day + ADT

Cariprazine 3 mg/Day + ADT

Placebo + ADT

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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

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 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.

Full Information

First Posted
November 8, 2018
Last Updated
September 29, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03738215
Brief Title
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
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 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
759 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine 1.5 mg/Day + ADT
Arm Type
Experimental
Arm Description
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).
Arm Title
Cariprazine 3 mg/Day + ADT
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo + ADT
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Cariprazine supplied in capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo supplied in capsules
Primary Outcome Measure Information:
Title
Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale)
Description
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.
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 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.
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]). 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbvie INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Alea Research /ID# 234789
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012-2707
Country
United States
Facility Name
Atria Clinical Research /ID# 237988
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209-7040
Country
United States
Facility Name
Woodland Research Northwest, LLC /ID# 236641
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758-6442
Country
United States
Facility Name
California Pharmaceutical Research Institute /ID# 236732
City
Anaheim
State/Province
California
ZIP/Postal Code
92804-3738
Country
United States
Facility Name
Advanced Research Center /ID# 237957
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Axiom Research /ID# 236268
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
ATP Clinical Research, Inc /ID# 236619
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626-4607
Country
United States
Facility Name
ProScience Research Group /ID# 236442
City
Culver City
State/Province
California
ZIP/Postal Code
90230-6632
Country
United States
Facility Name
Collaborative Neuroscience Research - Orange County /ID# 237639
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Irvine Clinical Research /ID# 237409
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Omega Clinical Trials LLC /ID# 238168
City
La Habra
State/Province
California
ZIP/Postal Code
90631-3842
Country
United States
Facility Name
Synergy San Diego /ID# 236654
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945-2956
Country
United States
Facility Name
Anderson Clinical Research /ID# 236627
City
Redlands
State/Province
California
ZIP/Postal Code
92374-4555
Country
United States
Facility Name
Sharp Mesa Vista Hospital /ID# 235797
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Viking Clinical Research /ID# 236614
City
Temecula
State/Province
California
ZIP/Postal Code
92591-6200
Country
United States
Facility Name
Olympian Clinical Research /ID# 237417
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Reliable Clinical Research /ID# 234786
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-5830
Country
United States
Facility Name
CNS Healthcare - Jacksonville /ID# 238241
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256-6039
Country
United States
Facility Name
Space Coast Neuropsychiatric Research Institute /ID# 235765
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32905
Country
United States
Facility Name
University of South Florida /ID# 234386
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Institute for Advanced Medical Research /ID# 236672
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022-1142
Country
United States
Facility Name
iResearch Atlanta, LLC /ID# 237389
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Psych Atlanta /ID# 235835
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Capstone Clinical Research /ID# 236546
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048-5341
Country
United States
Facility Name
Pillar Clinical Research /ID# 235702
City
Lincolnwood
State/Province
Illinois
ZIP/Postal Code
60712
Country
United States
Facility Name
NeuroPsychiatric Research Practice & Associate LTD /ID# 234636
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Lake Charles Clinical Trials /ID# 237723
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
J. Gary Booker MD APMC /ID# 234514
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Pharmasite Research, Inc. /ID# 237395
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
CBH Health LLC /ID# 234536
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Michigan Clinical Research Institute /ID# 234792
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-3205
Country
United States
Facility Name
NeuroBehavioral Medicine Group /ID# 236671
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Precise Research Centers /ID# 236598
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232-8839
Country
United States
Facility Name
Millennium Psychiatric Associates LLC /ID# 235989
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63132
Country
United States
Facility Name
Alivation Research /ID# 236583
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526-9474
Country
United States
Facility Name
Altea Research Institute /ID# 236726
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102-1955
Country
United States
Facility Name
Hassman Research Institute /ID# 237501
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Integrative Clinical Trials /ID# 236656
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229-3576
Country
United States
Facility Name
Manhattan Behavioral Medicine PLLC /ID# 236314
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Finger Lakes Clinical Research /ID# 236578
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-1609
Country
United States
Facility Name
New Hope Clinical Research Inc. /ID# 234557
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Richard Weisler MD, PA & Assoc /ID# 237424
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Quest Therapeutics of Avon Lake /ID# 236282
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
CTI Clinical Trial and Consulting /ID# 236271
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
The Ohio State University Department of Psychiatry /ID# 234583
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
CincyScience /ID# 236391
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
IPS Research Company /ID# 237671
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Sooner Clinical Research /ID# 236346
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc. - Portland /ID# 236649
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214-2569
Country
United States
Facility Name
Lehigh Center for Clinical Research /ID# 236702
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104-5034
Country
United States
Facility Name
Coastal Carolina Research Center /ID# 235909
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Psychiatric Consultants PC /ID# 235839
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Clinical Neuroscience Solutions - Memphis /ID# 237476
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Austin Clinical Trial Partners /ID# 236551
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
BioBehavioral Research of Austin /ID# 236477
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-5290
Country
United States
Facility Name
Houston Clinical Trials /ID# 234442
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401-2928
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP /ID# 236275
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Earle Research /ID# 236661
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Red Oak Psychiatry Associates /ID# 236600
City
Houston
State/Province
Texas
ZIP/Postal Code
77090-2641
Country
United States
Facility Name
AIM Trials /ID# 236369
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Pillar Clinical Research LLC /ID# 234465
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 236087
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Northwest Clinical Research Center /ID# 237584
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Core Clinical Research /ID# 236405
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
UMHAT Alexandrovska EAD /ID# 237834
City
Sofiya
State/Province
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 234625
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Facility Name
MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 234773
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
UMHAT Dr Georgi Stranski EAD /ID# 237828
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Medical Center Mentalcare OOD /ID# 234934
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Clinic of Psychiatry /ID# 235878
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Mental health Centre-Ruse EOOD /ID# 234775
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Medical Center Sveti Naum EOOD /ID# 236069
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Medical Center Hera EOOD /ID# 235859
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Medical complex Doverie /ID# 238307
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
Facility Name
Medical Centre - VAS OOD /ID# 235719
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Facility Name
Diagnostic consultative center Mladost M /ID# 236253
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Diagnostic consultative center Mladost M /ID# 236254
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo /ID# 236078
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Mental Health Center - Vratsa EOOD Hospital Pharmacy /ID# 235960
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Tartu University Hospital /ID# 237079
City
Tartu Linn
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Facility Name
West Tallinn Central Hospital /ID# 237078
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Marienthali Kliinik /ID# 235677
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Facility Name
OU Jaanson and Laane /ID# 234985
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Universitaetsklinikum Frankfurt /ID# 237292
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Private Practice - Dr. Thomsen /ID# 235713
City
Berlin
ZIP/Postal Code
10245
Country
Germany
Facility Name
Emovis GmbH /ID# 235010
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
MVZ LIO Berlin /ID# 235711
City
Berlin
ZIP/Postal Code
12209
Country
Germany
Facility Name
BAG Prof. Dr. Kunte / Dr. sc. med. A. Schulze /ID# 235970
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Facility Name
Arztpraxis Dr Kirsten Hahn /ID# 235958
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH /ID# 237758
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Studienzentrum Nord-West /ID# 236357
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Bacs-Kiskun Megyei Oktatokorhaz Szent-Kereszt Korhaz /ID# 235974
City
Kalocsa
State/Province
Bacs-Kiskun
ZIP/Postal Code
6300
Country
Hungary
Facility Name
PsychoTech Kft. /ID# 235008
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7627
Country
Hungary
Facility Name
Bugat Pal Korhaz /ID# 238145
City
Gyöngyös
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Szent Borbala Korhaz /ID# 238293
City
Tatabanya
State/Province
Komarom-Esztergom
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft. /ID# 237495
City
Budapest
State/Province
Pest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Clinexpert Kft /ID# 237266
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont /ID# 235095
City
Budapest
ZIP/Postal Code
1084
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 237096
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Nyiro Gyula Orszagos Pszichiatriai és Addiktologiai Intezet /ID# 235912
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Varoskapu Rendelo - Processus Kft. /ID# 235170
City
Budapest
ZIP/Postal Code
1137
Country
Hungary
Facility Name
Cherkasy regional psychiatric hospital of the CRC /ID# 234513
City
Smila
State/Province
Cherkaska Oblast
ZIP/Postal Code
20708
Country
Ukraine
Facility Name
Geikivka multidisciplinary hospital for psychiatric care /ID# 234498
City
Kryvbas Village
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
53054
Country
Ukraine
Facility Name
KNP Prykarpatskyi Regional Clinical Centre of Mental Health /ID# 234999
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236336
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236338
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 236340
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 234509
City
Stepanivka Village
State/Province
Khersonska Oblast
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Odesa regional psychiatric hospital 2 of the ORC /ID# 234505
City
Oleksandrivka Village
State/Province
Odeska Oblast
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 234499
City
Uzhgorod
State/Province
Zakarpatska Oblast
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
KNP Kyiv City Psychoneurological Hospital /ID# 235093
City
Kyiv
ZIP/Postal Code
02192
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hosp No.2 /ID# 237405
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 236270
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
MNCE Odesa Regional Medical Center for Mental Health /ID# 235723
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Ternopil University Hospital /ID# 236819
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Vinnytsia Regional Psycho-Neurological Hospital /ID# 235178
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Vinnytsia Regional Psycho-Neurological Hospital /ID# 235179
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Knowle House Surgery /ID# 235025
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL5 3JB
Country
United Kingdom
Facility Name
St. Peter's Hospital Surrey and Borders Partnership NHS FT /ID# 235725
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0AE
Country
United Kingdom
Facility Name
MAC Clinical Research /ID# 235938
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC Clinical Research /ID# 235941
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC Clinical Research /ID# 235945
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC Clinical Research /ID# 239078
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC Clinical Research-Manchester /ID# 235940
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom

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/

Learn more about this trial

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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