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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT04965272

Run by

AbbVie

People needed

0

Starts

2021-08-18

Expected to finish

2021-08-24

Last updated by the study team

2022-04-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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