Back to resultsA Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone (CAR aGAD Ph 2)
Primary Purpose
Generalized Anxiety Disorder
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cariprazine 0.75 mg/day
Cariprazine 1.5 mg/day
Cariprazine 3.0 mg/day
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder (GAD), Cariprazine, Vraylar, Depression, Antidepressant therapy
Eligibility Criteria
Inclusion Criteria:
- Participants with generalized anxiety disorder (GAD).
- Taking one of the FDA-approved antidepressant therapies (ADTs) for the treatment of GAD (i.e., escitalopram, paroxetine, duloxetine, and venlafaxine XR).
- Continuing to exhibit anxiety symptoms (Hamilton Anxiety Scale [HAM-A] total score >= 22) at Visit 1 (Screening) and Visit 2 (Baseline, Week 0) despite being on an adequate dose and duration (at least 6 weeks of continuous use, with a minimum of 3 of 6 weeks above the minimum labeled dose for GAD).
- Documentation of inadequate response to at least 1 ADT must be confirmed on the GAD-Antidepressant Treatment Response Questionnaire (GAD-ATRQ).
- Must have a minimum score of 22 on the rater-administrated HAM-A and a minimum score of 4 on the rater-administered Clinical Global Impression of Severity Scale (CGI-S), at both Visit 1 (Screening) and Visit 2 (Baseline, Week 0).
- A score of less than 12 on the rater-administered Hamilton Depression Rating Scale-17-item (HAMD-17) at Visit 1 (Screening) and Visit 2 (Baseline, Week 0).
- Laboratory values must meet the criteria specified in the protocol within the screening period prior to the first dose of study drug.
Exclusion Criteria:
- Psychiatric comorbidities, risk of suicide, self-injury, and/or harm to others; any current Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5) psychiatric diagnosis other than generalized anxiety disorder (GAD) (other than specific phobias) or history of alcohol or any other substance-related disorders within the 6 months before Visit 1 (Screening).
- Pregnancy, current breastfeeding status, plans to become pregnant or to donate eggs during the study or for approximately 30 days after the last dose of investigational product (female participants).
- History of an allergic reaction, hypersensitivity, or intolerance to constituents of cariprazine (and its excipients) and/or other products of the same class or to any of the protocol-approved rescue medications.
- Any clinically relevant or significant electrocardiogram (ECG) abnormalities, including ECG with QT interval corrected for heart rate (QTc) using Fridericia's formula (QTcF) >450 msec (males) or >470 msec (females).
- History of seizure disorder, with the exception of febrile seizure, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes to seizure.
- Specific medical conditions precluding study drug use and/or study participation, such as history of neuroleptic malignant syndrome; cataracts or retinal detachment; allergic reactions/hypersensitivity to cariprazine and/or protocol-approved rescue medications; pregnancy per above; cardiovascular disease; seizure history; and any other disease that is clinically unstable or would make the participant an unsuitable candidate to participate in the study, based on the investigator's judgment.
Sites / Locations
- Preferred Research Partners /ID# 232286
- Axiom Research /ID# 230728
- ATP Clinical Research, Inc /ID# 230445
- ProScience Research Group /ID# 231520
- WR-PRI, LLC - Encino /ID# 230434
- Synergy San Diego /ID# 231006
- Pharmacology Research Institute - Wake LLC /ID# 230722
- Pharmacology Research Inst /ID# 230869
- Anderson Clinical Research /ID# 230440
- California Neuroscience Research Medical Group, Inc. /ID# 230453
- Viking Clinical Research /ID# 230379
- Pacific Clinical Research Management Group /ID# 229725
- Galiz Research - Palmetto Medical Plaza /ID# 230446
- Great Lakes Clinical Trials /ID# 231296
- Baber Research Group /ID# 230447
- Boston Clinical Trials /ID# 231003
- ActivMed Practices and Research, LLC. /ID# 230441
- Alivation Research /ID# 230449
- Center for Emotional Fitness /ID# 230450
- Hassman Research Institute Marlton /ID# 233252
- Integrative Clinical Trials /ID# 230955
- SPRI Clinical Trails /ID# 230957
- Fieve Clinical Research, Inc. /ID# 230452
- Clinilabs, Inc. /ID# 230958
- Manhattan Behavioral Medicine PLLC /ID# 229713
- Carolina Institute for Clinical Research - Fayetteville /ID# 230961
- Ohio State Harding Hospital /ID# 231302
- CincyScience /ID# 229719
- Sooner Clinical Research /ID# 229731
- Research Strategies of Memphis /ID# 230443
- Clinical Neuroscience Solutions - Memphis /ID# 230734
- Austin Clinical Trial Partners /ID# 229727
- FutureSearch Trials of Dallas, LP /ID# 230535
- Earle Research /ID# 230969
- Grayline Research Center /ID# 230455
- Woodstock Research Center /ID# 231005
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Cariprazine 0.75 mg/day + Antidepressant Therapy
Cariprazine 1.5 mg/day + Antidepressant Therapy
Cariprazine 3.0 mg/day + Antidepressant Therapy
Placebo + Antidepressant Therapy
Arm Description
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 0.75 mg/day oral, once daily for 6 weeks
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral, once daily for 6 weeks
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral for 2 weeks followed by cariprazine 3.0 mg/day oral, once daily for 4 weeks.
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + oral placebo, once daily for 6 weeks
Outcomes
Primary Outcome Measures
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.
Secondary Outcome Measures
Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S)
The CGI-S is a single, clinician-reported item that measures the clinician's impression of a subject's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 5-point Likert rating scale, with higher scores indicating greater anxiety severity.
Percentage of Participants in Remission
Remission is defined as HAM-A total score <=7, Clinical Global Impression of Improvement Scale (CGI-I) = 1, and Sheehan Disability Scale: Anxiety (SDS: Anxiety) total score <= 5
Percentage of Participants with HAM-A Response
HAM-A response is defined as >= 50% reduction from baseline in HAM-A total score
Percentage of Participants with CGI-I Responder Status of "Much Better" or "Very Much Better"
The CGI-I is a single, clinician reported item that measures the clinician's impression of how much a participant's anxiety has changed since starting the study medication compared to the participant's condition at baseline. The measure uses a 7-point Likert rating scale with responses ranging from "very much better" (1) to "very much worse" (7).
Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Responder Status of "Much Better" or "Very Much Better"
The PGI-C is a single, patient-reported item that assesses the participant's perceived overall change in their anxiety since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "very much better" (1) to "very much worse" (7).
Change from Baseline in Patient Global Impression of Severity Scale (PGI-S)
The PGI-S is a single, patient-reported item that assesses the participant's perceived level of anxiety over the past 7 days. The measure uses a 5-point Likert rating scale with responses ranging from "none" (1) to "very severe" (5), with higher scores indicating greater anxiety severity.
Change from Baseline in SDS: Anxiety Total Score
The SDS: Anxiety is a 5-item, patient-reported measure used to assess functional impairment in the domains of work/school, social life, and family life on a 10-point numeric rating scale with verbal anchors. The 3 items assessing work/school, social life, and home life or family responsibilities impairment are summed into a single dimensional measure of global functional impairment, with scores ranging from 0 (unimpaired) to 30 (highly impaired). Higher scores indicate greater impairment.
Change from Baseline in Hamilton Depression Rating Scale-17 item, via Structured Interview Guide for the Hamilton Depression Scale (HAMD-17) Total Score
The HAMD-17 is a 17-item, clinician-reported measure used to quantify and categorize the participant's depression over the past week. The HAMD-17 total score ranges from 0 to 52 with higher scores indicating greater depression severity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04965272
Brief Title
A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone
Acronym
CAR aGAD Ph 2
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose, Phase 2 Study Evaluating the Safety and Efficacy of Cariprazine as an Adjunctive Therapy to Antidepressant Therapies (ADTs), in the Treatment of Subjects With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADT Alone
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Strategic Decision
Study Start Date
August 18, 2021 (Anticipated)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess adverse events and the change in disease activity with cariprazine when added to ADTs compared with placebo in adult participants with GAD who have had an inadequate response to 1 or more prior ADTs alone.
Cariprazine is an approved drug being developed for the treatment of GAD. The participants are placed into 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 1072 participants age 18-65 with GAD and an inadequate response to ADT alone will be enrolled in the study in the United States.
After a 2-week screening period, participants will receive daily oral capsules of cariprazine of varying doses or placebo for 6 weeks, followed by a 4-week safety follow-up period for a total study duration of 10 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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
Generalized Anxiety Disorder
Keywords
Generalized Anxiety Disorder (GAD), Cariprazine, Vraylar, Depression, Antidepressant therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cariprazine 0.75 mg/day + Antidepressant Therapy
Arm Type
Experimental
Arm Description
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 0.75 mg/day oral, once daily for 6 weeks
Arm Title
Cariprazine 1.5 mg/day + Antidepressant Therapy
Arm Type
Experimental
Arm Description
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral, once daily for 6 weeks
Arm Title
Cariprazine 3.0 mg/day + Antidepressant Therapy
Arm Type
Experimental
Arm Description
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral for 2 weeks followed by cariprazine 3.0 mg/day oral, once daily for 4 weeks.
Arm Title
Placebo + Antidepressant Therapy
Arm Type
Placebo Comparator
Arm Description
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + oral placebo, once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Cariprazine 0.75 mg/day
Other Intervention Name(s)
Vraylar
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Cariprazine 1.5 mg/day
Other Intervention Name(s)
Vraylar
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Cariprazine 3.0 mg/day
Other Intervention Name(s)
Vraylar
Intervention Description
Oral Capsule
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Description
The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S)
Description
The CGI-S is a single, clinician-reported item that measures the clinician's impression of a subject's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 5-point Likert rating scale, with higher scores indicating greater anxiety severity.
Time Frame
Week 6
Title
Percentage of Participants in Remission
Description
Remission is defined as HAM-A total score <=7, Clinical Global Impression of Improvement Scale (CGI-I) = 1, and Sheehan Disability Scale: Anxiety (SDS: Anxiety) total score <= 5
Time Frame
Week 6
Title
Percentage of Participants with HAM-A Response
Description
HAM-A response is defined as >= 50% reduction from baseline in HAM-A total score
Time Frame
Week 6
Title
Percentage of Participants with CGI-I Responder Status of "Much Better" or "Very Much Better"
Description
The CGI-I is a single, clinician reported item that measures the clinician's impression of how much a participant's anxiety has changed since starting the study medication compared to the participant's condition at baseline. The measure uses a 7-point Likert rating scale with responses ranging from "very much better" (1) to "very much worse" (7).
Time Frame
Week 6
Title
Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Responder Status of "Much Better" or "Very Much Better"
Description
The PGI-C is a single, patient-reported item that assesses the participant's perceived overall change in their anxiety since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "very much better" (1) to "very much worse" (7).
Time Frame
Week 6
Title
Change from Baseline in Patient Global Impression of Severity Scale (PGI-S)
Description
The PGI-S is a single, patient-reported item that assesses the participant's perceived level of anxiety over the past 7 days. The measure uses a 5-point Likert rating scale with responses ranging from "none" (1) to "very severe" (5), with higher scores indicating greater anxiety severity.
Time Frame
Week 6
Title
Change from Baseline in SDS: Anxiety Total Score
Description
The SDS: Anxiety is a 5-item, patient-reported measure used to assess functional impairment in the domains of work/school, social life, and family life on a 10-point numeric rating scale with verbal anchors. The 3 items assessing work/school, social life, and home life or family responsibilities impairment are summed into a single dimensional measure of global functional impairment, with scores ranging from 0 (unimpaired) to 30 (highly impaired). Higher scores indicate greater impairment.
Time Frame
Week 6
Title
Change from Baseline in Hamilton Depression Rating Scale-17 item, via Structured Interview Guide for the Hamilton Depression Scale (HAMD-17) Total Score
Description
The HAMD-17 is a 17-item, clinician-reported measure used to quantify and categorize the participant's depression over the past week. The HAMD-17 total score ranges from 0 to 52 with higher scores indicating greater depression severity.
Time Frame
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:
Participants with generalized anxiety disorder (GAD).
Taking one of the FDA-approved antidepressant therapies (ADTs) for the treatment of GAD (i.e., escitalopram, paroxetine, duloxetine, and venlafaxine XR).
Continuing to exhibit anxiety symptoms (Hamilton Anxiety Scale [HAM-A] total score >= 22) at Visit 1 (Screening) and Visit 2 (Baseline, Week 0) despite being on an adequate dose and duration (at least 6 weeks of continuous use, with a minimum of 3 of 6 weeks above the minimum labeled dose for GAD).
Documentation of inadequate response to at least 1 ADT must be confirmed on the GAD-Antidepressant Treatment Response Questionnaire (GAD-ATRQ).
Must have a minimum score of 22 on the rater-administrated HAM-A and a minimum score of 4 on the rater-administered Clinical Global Impression of Severity Scale (CGI-S), at both Visit 1 (Screening) and Visit 2 (Baseline, Week 0).
A score of less than 12 on the rater-administered Hamilton Depression Rating Scale-17-item (HAMD-17) at Visit 1 (Screening) and Visit 2 (Baseline, Week 0).
Laboratory values must meet the criteria specified in the protocol within the screening period prior to the first dose of study drug.
Exclusion Criteria:
Psychiatric comorbidities, risk of suicide, self-injury, and/or harm to others; any current Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5) psychiatric diagnosis other than generalized anxiety disorder (GAD) (other than specific phobias) or history of alcohol or any other substance-related disorders within the 6 months before Visit 1 (Screening).
Pregnancy, current breastfeeding status, plans to become pregnant or to donate eggs during the study or for approximately 30 days after the last dose of investigational product (female participants).
History of an allergic reaction, hypersensitivity, or intolerance to constituents of cariprazine (and its excipients) and/or other products of the same class or to any of the protocol-approved rescue medications.
Any clinically relevant or significant electrocardiogram (ECG) abnormalities, including ECG with QT interval corrected for heart rate (QTc) using Fridericia's formula (QTcF) >450 msec (males) or >470 msec (females).
History of seizure disorder, with the exception of febrile seizure, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes to seizure.
Specific medical conditions precluding study drug use and/or study participation, such as history of neuroleptic malignant syndrome; cataracts or retinal detachment; allergic reactions/hypersensitivity to cariprazine and/or protocol-approved rescue medications; pregnancy per above; cardiovascular disease; seizure history; and any other disease that is clinically unstable or would make the participant an unsuitable candidate to participate in the study, based on the investigator's judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Preferred Research Partners /ID# 232286
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Axiom Research /ID# 230728
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
ATP Clinical Research, Inc /ID# 230445
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626-4607
Country
United States
Facility Name
ProScience Research Group /ID# 231520
City
Culver City
State/Province
California
ZIP/Postal Code
90230-6632
Country
United States
Facility Name
WR-PRI, LLC - Encino /ID# 230434
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Synergy San Diego /ID# 231006
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945-2956
Country
United States
Facility Name
Pharmacology Research Institute - Wake LLC /ID# 230722
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3500
Country
United States
Facility Name
Pharmacology Research Inst /ID# 230869
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Anderson Clinical Research /ID# 230440
City
Redlands
State/Province
California
ZIP/Postal Code
92374-4555
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc. /ID# 230453
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403-2109
Country
United States
Facility Name
Viking Clinical Research /ID# 230379
City
Temecula
State/Province
California
ZIP/Postal Code
92591-6200
Country
United States
Facility Name
Pacific Clinical Research Management Group /ID# 229725
City
Upland
State/Province
California
ZIP/Postal Code
91786-3676
Country
United States
Facility Name
Galiz Research - Palmetto Medical Plaza /ID# 230446
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Great Lakes Clinical Trials /ID# 231296
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Baber Research Group /ID# 230447
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563-6502
Country
United States
Facility Name
Boston Clinical Trials /ID# 231003
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131-2515
Country
United States
Facility Name
ActivMed Practices and Research, LLC. /ID# 230441
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Alivation Research /ID# 230449
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526-9474
Country
United States
Facility Name
Center for Emotional Fitness /ID# 230450
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002-3008
Country
United States
Facility Name
Hassman Research Institute Marlton /ID# 233252
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053-1930
Country
United States
Facility Name
Integrative Clinical Trials /ID# 230955
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229-3576
Country
United States
Facility Name
SPRI Clinical Trails /ID# 230957
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235-5660
Country
United States
Facility Name
Fieve Clinical Research, Inc. /ID# 230452
City
New York
State/Province
New York
ZIP/Postal Code
10017-1921
Country
United States
Facility Name
Clinilabs, Inc. /ID# 230958
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Manhattan Behavioral Medicine PLLC /ID# 229713
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Carolina Institute for Clinical Research - Fayetteville /ID# 230961
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
Ohio State Harding Hospital /ID# 231302
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1250
Country
United States
Facility Name
CincyScience /ID# 229719
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Sooner Clinical Research /ID# 229731
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Research Strategies of Memphis /ID# 230443
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-5202
Country
United States
Facility Name
Clinical Neuroscience Solutions - Memphis /ID# 230734
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Austin Clinical Trial Partners /ID# 229727
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP /ID# 230535
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Earle Research /ID# 230969
City
Houston
State/Province
Texas
ZIP/Postal Code
77058-2746
Country
United States
Facility Name
Grayline Research Center /ID# 230455
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309-1608
Country
United States
Facility Name
Woodstock Research Center /ID# 231005
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091-9795
Country
United States
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
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
https://www.rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response to ADTs Alone
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