Back to resultsA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
Primary Purpose
Depression, Bipolar I Disorder
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, RGH-188, Bipolar I Disorder, Vraylar, Cariprazine
Eligibility Criteria
Inclusion Criteria:
- Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
- Current depressive episode is more than 4 weeks and less than 12 months in duration.
- Participant has a lifetime history of at least one manic episode.
- Children's Depression Rating Scale - Revised (CDRS-R) score > = 45 at Visit 1 and Visit 2.
- Young-Mania Rating Scale (YMRS) score < = 12 with YMRS Item 1 (elevated mood) score < = 2 at Visit 1 and Visit 2.
- Clinical Global Impression-Severity (CGI-S) scale score of > = 4 (moderately ill) at Visit 1 and Visit 2.
Exclusion Criteria:
- Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.
- Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder within the 3 months before Screening Visit 1.
- History of serotonin syndrome or neuroleptic malignant syndrome.
- Four or more episodes of a mood disturbance within the 12 months before Visit 1.
- DSM-5 diagnosis of intellectual disability (IQ < 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment.
- History of seizures, with the exception of febrile seizures.
- Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures.
- Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers.
- Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component.
- Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1.
- Treatment with clozapine in a dose of > 50 mg/d in the past 2 years.
Sites / Locations
- Pillar Clinical Research /ID# 226504
- Advanced Research Center /ID# 227073Recruiting
- Care Access Research /ID# 226316
- ProScience Research Group /ID# 226223
- Alliance for Research - Long Beach /ID# 226522Recruiting
- Prospective Research Innovations Inc /ID# 240774Recruiting
- University of California, San Diego Department of Psychiatry /ID# 226463
- Pacific Clinical Research Management Group /ID# 227075Recruiting
- Advanced Research Institute of Miami /ID# 228222Recruiting
- South Florida Research Ph I-IV /ID# 240778Recruiting
- Columbus Clinical Services, Llc /Id# 229792Recruiting
- Florida Research Center, Inc. /ID# 240775Recruiting
- D&H Tamarac Research Center /ID# 250434Recruiting
- University of South Florida /ID# 246508Recruiting
- Atlanta Center for Medical Research /ID# 226480Recruiting
- CenExcel iResearch LLC /ID# 228695Recruiting
- Atlanta Behavioral Research, LLC /ID# 226486Recruiting
- Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371Recruiting
- Ascension St. Elizabeth /ID# 240772Recruiting
- Baber Research Group /ID# 232279
- The Kennedy Krieger Institute /ID# 226509Recruiting
- Med Clinical Research Partners LLC /ID# 240773Recruiting
- NeuroCognitive and Behavioral Institute, Inc /ID# 227077
- UB Department of Psychiatry /ID# 226373Recruiting
- New Dawn Psychiatric Services PLLC /ID# 229782Recruiting
- Quest Therapeutics of Avon Lake /ID# 226349Recruiting
- University of Cincinnati /ID# 226465Recruiting
- CincyScience /ID# 226318Recruiting
- IPS Research Company /ID# 227072
- Sooner Clinical Research /ID# 226384Recruiting
- Cutting Edge Research Group /ID# 240777Recruiting
- BioBehavioral Research of Austin /ID# 227076Recruiting
- Relaro Medical Trials /ID# 227156Recruiting
- McGovern Medical School /ID# 240779
- Southwest Biomed Research Center LLC /ID# 226340
- Red Oak Psychiatry Associates /ID# 240776Recruiting
- AIM Trials /ID# 226367Recruiting
- Family Psychiatry of The Woodlands /ID# 226290Recruiting
- Dr. Samuel Sanchez PSC /ID# 245952Recruiting
- GCM Medical Group PSC /ID# 245951Recruiting
- Psychotherapeutics Center Podderzhka /ID# 226348
- Clinica of Glazunova /ID# 229416
- Scientific Centre of Personalized Medicine /ID# 226380
- Central Clinical Psychiatric Hospital /ID# 226381
- Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
- Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
- Medgard Clinic /ID# 228598
- Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
- Psychiatric hospital #1 /ID# 226516
- National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Cariprazine
Arm Description
Participants will receive Placebo over a 6 week treatment period.
Participants will receive flexible dose Cariprazine over a 6 week treatment period.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.
Abnormal Change from Baseline in Vital Signs
Change in vital signs like systolic and diastolic blood pressure will be assessed.
Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results
Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
Change in Electrocardiogram (ECG)
12 -lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Change in Children's Depression Rating Scale - Revised (CDRS-S) Total Score
The CDRS R is a 17-item clinician-administered scale specifically developed for the assessment of depressive symptoms in children and adolescents. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. The CDRS R will be administered by a clinician with extensive professional training in mental illness.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04777357
Brief Title
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
Official Title
A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Participants (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
January 29, 2025 (Anticipated)
Study Completion Date
January 29, 2025 (Anticipated)
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
Yes
5. Study Description
Brief Summary
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population.
Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide.
Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar I Disorder
Keywords
Depression, RGH-188, Bipolar I Disorder, Vraylar, Cariprazine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo over a 6 week treatment period.
Arm Title
Cariprazine
Arm Type
Experimental
Arm Description
Participants will receive flexible dose Cariprazine over a 6 week treatment period.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
Vraylar
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.
Time Frame
Baseline (Week 0) to Week 10
Title
Abnormal Change from Baseline in Vital Signs
Description
Change in vital signs like systolic and diastolic blood pressure will be assessed.
Time Frame
Baseline (Week 0) to Week 10
Title
Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results
Description
Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
Time Frame
Baseline (Week 0) to Week 6
Title
Change in Electrocardiogram (ECG)
Description
12 -lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Time Frame
Baseline (Week 0) to Week 6
Title
Change in Children's Depression Rating Scale - Revised (CDRS-S) Total Score
Description
The CDRS R is a 17-item clinician-administered scale specifically developed for the assessment of depressive symptoms in children and adolescents. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. The CDRS R will be administered by a clinician with extensive professional training in mental illness.
Time Frame
Baseline (Week 0) to Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
Current depressive episode is more than 2 weeks and less than 12 months in duration.
Participant has a lifetime history of at least one manic episode.
Children's Depression Rating Scale - Revised (CDRS-R) score > = 45 at Visit 1 and Visit 2.
Young-Mania Rating Scale (YMRS) score < 12 with YMRS Item 1 (elevated mood) score < 2 at Visit 1 and Visit 2.
Clinical Global Impression-Severity (CGI-S) scale score of > = 4 (moderately ill) at Visit 1 and Visit 2.
Exclusion Criteria:
Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.
Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder within the 3 months before Screening Visit 1.
History of serotonin syndrome or neuroleptic malignant syndrome.
Four or more episodes of a mood disturbance within the 12 months before Visit 1.
DSM-5 diagnosis of intellectual disability (IQ < 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment.
History of seizures, with the exception of febrile seizures.
Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures.
Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers.
Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component.
Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1.
Treatment with clozapine in a dose of >= 50 mg/d in the past 2 years.
Participants with cataracts, ocular trauma, ocular disease, history of amiodarone or systemic corticosteroid use for >= 3 consecutive months in the past year, and IOP of >= 21 mm Hg in either eye.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Pillar Clinical Research /ID# 226504
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Individual Site Status
Completed
Facility Name
Advanced Research Center /ID# 227073
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access Research /ID# 226316
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Individual Site Status
Completed
Facility Name
ProScience Research Group /ID# 226223
City
Culver City
State/Province
California
ZIP/Postal Code
90230-6632
Country
United States
Individual Site Status
Completed
Facility Name
Alliance for Research - Long Beach /ID# 226522
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Name
Prospective Research Innovations Inc /ID# 240774
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Diego Department of Psychiatry /ID# 226463
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8229
Country
United States
Individual Site Status
Completed
Facility Name
Pacific Clinical Research Management Group /ID# 227075
City
Upland
State/Province
California
ZIP/Postal Code
91786-3676
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Institute of Miami /ID# 228222
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030-4613
Country
United States
Individual Site Status
Recruiting
Facility Name
South Florida Research Ph I-IV /ID# 240778
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166-7225
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Clinical Services, Llc /Id# 229792
City
Miami
State/Province
Florida
ZIP/Postal Code
33125-5114
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Research Center, Inc. /ID# 240775
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H Tamarac Research Center /ID# 250434
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321-2979
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida /ID# 246508
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-2201
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Center for Medical Research /ID# 226480
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Name
CenExcel iResearch LLC /ID# 228695
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Behavioral Research, LLC /ID# 226486
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Individual Site Status
Recruiting
Facility Name
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension St. Elizabeth /ID# 240772
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Individual Site Status
Recruiting
Facility Name
Baber Research Group /ID# 232279
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563-6502
Country
United States
Individual Site Status
Completed
Facility Name
The Kennedy Krieger Institute /ID# 226509
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Name
Med Clinical Research Partners LLC /ID# 240773
City
Irvington
State/Province
New Jersey
ZIP/Postal Code
07111
Country
United States
Individual Site Status
Recruiting
Facility Name
NeuroCognitive and Behavioral Institute, Inc /ID# 227077
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856-1315
Country
United States
Individual Site Status
Completed
Facility Name
UB Department of Psychiatry /ID# 226373
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Recruiting
Facility Name
New Dawn Psychiatric Services PLLC /ID# 229782
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501-1603
Country
United States
Individual Site Status
Recruiting
Facility Name
Quest Therapeutics of Avon Lake /ID# 226349
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati /ID# 226465
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
CincyScience /ID# 226318
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Individual Site Status
Recruiting
Facility Name
IPS Research Company /ID# 227072
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Completed
Facility Name
Sooner Clinical Research /ID# 226384
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Cutting Edge Research Group /ID# 240777
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116-1423
Country
United States
Individual Site Status
Recruiting
Facility Name
BioBehavioral Research of Austin /ID# 227076
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-5290
Country
United States
Individual Site Status
Recruiting
Facility Name
Relaro Medical Trials /ID# 227156
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Name
McGovern Medical School /ID# 240779
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Completed
Facility Name
Southwest Biomed Research Center LLC /ID# 226340
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Individual Site Status
Completed
Facility Name
Red Oak Psychiatry Associates /ID# 240776
City
Houston
State/Province
Texas
ZIP/Postal Code
77090-2641
Country
United States
Individual Site Status
Recruiting
Facility Name
AIM Trials /ID# 226367
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
Family Psychiatry of The Woodlands /ID# 226290
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Samuel Sanchez PSC /ID# 245952
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
GCM Medical Group PSC /ID# 245951
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Psychotherapeutics Center Podderzhka /ID# 226348
City
Stavropol
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
355029
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinica of Glazunova /ID# 229416
City
Krasnodar
ZIP/Postal Code
350051
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Scientific Centre of Personalized Medicine /ID# 226380
City
Moscow
ZIP/Postal Code
105082
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Central Clinical Psychiatric Hospital /ID# 226381
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
City
Orenburg
ZIP/Postal Code
460006
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Medgard Clinic /ID# 228598
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Psychiatric hospital #1 /ID# 226516
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Individual Site Status
Completed
Facility Name
National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Completed
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, analyses plans, 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 visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
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