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
NCT ID: NCT04965272
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2021-08-18
2021-08-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder
NCT06846320
Cariprazine Versus Placebo for Social Anxiety Disorder
NCT05384483
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
NCT06480383
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
NCT06701903
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
NCT00236054
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cariprazine 0.75 mg/day + Antidepressant Therapy
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 0.75 mg/day oral, once daily for 6 weeks
Cariprazine 0.75 mg/day
Oral Capsule
Cariprazine 1.5 mg/day + Antidepressant Therapy
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral, once daily for 6 weeks
Cariprazine 1.5 mg/day
Oral Capsule
Cariprazine 3.0 mg/day + Antidepressant Therapy
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.
Cariprazine 3.0 mg/day
Oral Capsule
Placebo + Antidepressant Therapy
Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + oral placebo, once daily for 6 weeks
Placebo
Oral Capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cariprazine 0.75 mg/day
Oral Capsule
Cariprazine 1.5 mg/day
Oral Capsule
Cariprazine 3.0 mg/day
Oral Capsule
Placebo
Oral Capsule
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Preferred Research Partners /ID# 232286
Little Rock, Arkansas, United States
Axiom Research /ID# 230728
Colton, California, United States
ATP Clinical Research, Inc /ID# 230445
Costa Mesa, California, United States
ProScience Research Group /ID# 231520
Culver City, California, United States
WR-PRI, LLC - Encino /ID# 230434
Encino, California, United States
Synergy San Diego /ID# 231006
Lemon Grove, California, United States
Pharmacology Research Institute - Wake LLC /ID# 230722
Los Alamitos, California, United States
Pharmacology Research Inst /ID# 230869
Newport Beach, California, United States
Anderson Clinical Research /ID# 230440
Redlands, California, United States
California Neuroscience Research Medical Group, Inc. /ID# 230453
Sherman Oaks, California, United States
Viking Clinical Research /ID# 230379
Temecula, California, United States
Pacific Clinical Research Management Group /ID# 229725
Upland, California, United States
Galiz Research - Palmetto Medical Plaza /ID# 230446
Hialeah, Florida, United States
Great Lakes Clinical Trials /ID# 231296
Chicago, Illinois, United States
Baber Research Group /ID# 230447
Naperville, Illinois, United States
Boston Clinical Trials /ID# 231003
Boston, Massachusetts, United States
ActivMed Practices and Research, LLC. /ID# 230441
Methuen, Massachusetts, United States
Alivation Research /ID# 230449
Lincoln, Nebraska, United States
Center for Emotional Fitness /ID# 230450
Cherry Hill, New Jersey, United States
Hassman Research Institute Marlton /ID# 233252
Marlton, New Jersey, United States
Integrative Clinical Trials /ID# 230955
Brooklyn, New York, United States
SPRI Clinical Trails /ID# 230957
Brooklyn, New York, United States
Fieve Clinical Research, Inc. /ID# 230452
New York, New York, United States
Clinilabs, Inc. /ID# 230958
New York, New York, United States
Manhattan Behavioral Medicine PLLC /ID# 229713
New York, New York, United States
Carolina Institute for Clinical Research - Fayetteville /ID# 230961
Fayetteville, North Carolina, United States
Ohio State Harding Hospital /ID# 231302
Columbus, Ohio, United States
CincyScience /ID# 229719
West Chester, Ohio, United States
Sooner Clinical Research /ID# 229731
Oklahoma City, Oklahoma, United States
Research Strategies of Memphis /ID# 230443
Memphis, Tennessee, United States
Clinical Neuroscience Solutions - Memphis /ID# 230734
Memphis, Tennessee, United States
Austin Clinical Trial Partners /ID# 229727
Austin, Texas, United States
FutureSearch Trials of Dallas, LP /ID# 230535
Dallas, Texas, United States
Earle Research /ID# 230969
Houston, Texas, United States
Grayline Research Center /ID# 230455
Wichita Falls, Texas, United States
Woodstock Research Center /ID# 231005
Woodstock, Vermont, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M21-209
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.