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

NCT04965272 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: M21-209
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 36

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.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder (GAD); Cariprazine; Vraylar; Depression; Antidepressant therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 6

Secondary Outcomes (8)

• Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S)

  Week 6

• Percentage of Participants in Remission

  Week 6

• Percentage of Participants with HAM-A Response

  Week 6

• Percentage of Participants with CGI-I Responder Status of "Much Better" or "Very Much Better"

  Week 6

• Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Responder Status of "Much Better" or "Very Much Better"

  Week 6

Study Arms (4)

Cariprazine 0.75 mg/day + Antidepressant Therapy

EXPERIMENTAL

Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 0.75 mg/day oral, once daily for 6 weeks

Drug: Cariprazine 0.75 mg/day

Cariprazine 1.5 mg/day + Antidepressant Therapy

EXPERIMENTAL

Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral, once daily for 6 weeks

Drug: Cariprazine 1.5 mg/day

Cariprazine 3.0 mg/day + Antidepressant Therapy

EXPERIMENTAL

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.

Drug: Cariprazine 3.0 mg/day

Placebo + Antidepressant Therapy

PLACEBO COMPARATOR

Antidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + oral placebo, once daily for 6 weeks

Other: Placebo

Interventions

Cariprazine 0.75 mg/day DRUG

Oral Capsule

Also known as: Vraylar

Cariprazine 0.75 mg/day + Antidepressant Therapy

Cariprazine 1.5 mg/day DRUG

Oral Capsule

Also known as: Vraylar

Cariprazine 1.5 mg/day + Antidepressant Therapy

Cariprazine 3.0 mg/day DRUG

Oral Capsule

Also known as: Vraylar

Cariprazine 3.0 mg/day + Antidepressant Therapy

Placebo OTHER

Oral Capsule

Placebo + Antidepressant Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (36)

Preferred Research Partners /ID# 232286

Little Rock, Arkansas, 72211, United States

Location

Axiom Research /ID# 230728

Colton, California, 92324, United States

Location

ATP Clinical Research, Inc /ID# 230445

Costa Mesa, California, 92626-4607, United States

Location

ProScience Research Group /ID# 231520

Culver City, California, 90230-6632, United States

Location

WR-PRI, LLC - Encino /ID# 230434

Encino, California, 91316, United States

Location

Synergy San Diego /ID# 231006

Lemon Grove, California, 91945-2956, United States

Location

Pharmacology Research Institute - Wake LLC /ID# 230722

Los Alamitos, California, 90720-3500, United States

Location

Pharmacology Research Inst /ID# 230869

Newport Beach, California, 92660, United States

Location

Anderson Clinical Research /ID# 230440

Redlands, California, 92374-4555, United States

Location

California Neuroscience Research Medical Group, Inc. /ID# 230453

Sherman Oaks, California, 91403-2109, United States

Location

Viking Clinical Research /ID# 230379

Temecula, California, 92591-6200, United States

Location

Pacific Clinical Research Management Group /ID# 229725

Upland, California, 91786-3676, United States

Location

Galiz Research - Palmetto Medical Plaza /ID# 230446

Hialeah, Florida, 33016, United States

Location

Great Lakes Clinical Trials /ID# 231296

Chicago, Illinois, 60640, United States

Location

Baber Research Group /ID# 230447

Naperville, Illinois, 60563-6502, United States

Location

Boston Clinical Trials /ID# 231003

Boston, Massachusetts, 02131-2515, United States

Location

ActivMed Practices and Research, LLC. /ID# 230441

Methuen, Massachusetts, 01844, United States

Location

Alivation Research /ID# 230449

Lincoln, Nebraska, 68526-9474, United States

Location

Center for Emotional Fitness /ID# 230450

Cherry Hill, New Jersey, 08002-3008, United States

Location

Hassman Research Institute Marlton /ID# 233252

Marlton, New Jersey, 08053-1930, United States

Location

Integrative Clinical Trials /ID# 230955

Brooklyn, New York, 11229-3576, United States

Location

SPRI Clinical Trails /ID# 230957

Brooklyn, New York, 11235-5660, United States

Location

Fieve Clinical Research, Inc. /ID# 230452

New York, New York, 10017-1921, United States

Location

Clinilabs, Inc. /ID# 230958

New York, New York, 10019, United States

Location

Manhattan Behavioral Medicine PLLC /ID# 229713

New York, New York, 10036, United States

Location

Carolina Institute for Clinical Research - Fayetteville /ID# 230961

Fayetteville, North Carolina, 28303, United States

Location

Ohio State Harding Hospital /ID# 231302

Columbus, Ohio, 43210-1250, United States

Location

CincyScience /ID# 229719

West Chester, Ohio, 45069, United States

Location

Sooner Clinical Research /ID# 229731

Oklahoma City, Oklahoma, 73112, United States

Location

Research Strategies of Memphis /ID# 230443

Memphis, Tennessee, 38119-5202, United States

Location

Clinical Neuroscience Solutions - Memphis /ID# 230734

Memphis, Tennessee, 38119, United States

Location

Austin Clinical Trial Partners /ID# 229727

Austin, Texas, 78737, United States

Location

FutureSearch Trials of Dallas, LP /ID# 230535

Dallas, Texas, 75231, United States

Location

Earle Research /ID# 230969

Houston, Texas, 77058-2746, United States

Location

Grayline Research Center /ID# 230455

Wichita Falls, Texas, 76309-1608, United States

Location

Woodstock Research Center /ID# 231005

Woodstock, Vermont, 05091-9795, United States

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depression

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: August 18, 2021
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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.

Locations

US (36)