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Generalized Anxiety DisorderPhase 2CAR aGAD Ph 2NCT04965272

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

A Phase 2 study testing Cariprazine 0.75 mg/day, Cariprazine 1.5 mg/day and Cariprazine 3.0 mg/day in people with Generalized Anxiety Disorder, run by AbbVie at 36 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Generalized Anxiety Disorder
What is being tested?
Cariprazine 0.75 mg/day, Cariprazine 1.5 mg/day and Cariprazine 3.0 mg/day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
36 sitesUnited States
Study dates
18 Aug 2021to 24 Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Austin Clinical Trial Partners /ID# 229727

    Austin, Texas, 78737

  • Boston Clinical Trials /ID# 231003

    Boston, Massachusetts, 02131-2515

  • Integrative Clinical Trials /ID# 230955

    Brooklyn, New York, 11229-3576

  • SPRI Clinical Trails /ID# 230957

    Brooklyn, New York, 11235-5660

  • Center for Emotional Fitness /ID# 230450

    Cherry Hill, New Jersey, 08002-3008

  • Great Lakes Clinical Trials /ID# 231296

    Chicago, Illinois, 60640

  • Axiom Research /ID# 230728

    Colton, California, 92324

  • Ohio State Harding Hospital /ID# 231302

    Columbus, Ohio, 43210-1250

  • ATP Clinical Research, Inc /ID# 230445

    Costa Mesa, California, 92626-4607

  • ProScience Research Group /ID# 231520

    Culver City, California, 90230-6632

  • FutureSearch Trials of Dallas, LP /ID# 230535

    Dallas, Texas, 75231

  • WR-PRI, LLC - Encino /ID# 230434

    Encino, California, 91316

  • Carolina Institute for Clinical Research - Fayetteville /ID# 230961

    Fayetteville, North Carolina, 28303

  • Galiz Research - Palmetto Medical Plaza /ID# 230446

    Hialeah, Florida, 33016

  • Earle Research /ID# 230969

    Houston, Texas, 77058-2746

  • Synergy San Diego /ID# 231006

    Lemon Grove, California, 91945-2956

  • Alivation Research /ID# 230449

    Lincoln, Nebraska, 68526-9474

  • Preferred Research Partners /ID# 232286

    Little Rock, Arkansas, 72211

  • Pharmacology Research Institute - Wake LLC /ID# 230722

    Los Alamitos, California, 90720-3500

  • Hassman Research Institute Marlton /ID# 233252

    Marlton, New Jersey, 08053-1930

  • Research Strategies of Memphis /ID# 230443

    Memphis, Tennessee, 38119-5202

  • Clinical Neuroscience Solutions - Memphis /ID# 230734

    Memphis, Tennessee, 38119

  • ActivMed Practices and Research, LLC. /ID# 230441

    Methuen, Massachusetts, 01844

  • Baber Research Group /ID# 230447

    Naperville, Illinois, 60563-6502

  • Fieve Clinical Research, Inc. /ID# 230452

    New York, New York, 10017-1921

  • Clinilabs, Inc. /ID# 230958

    New York, New York, 10019

  • Manhattan Behavioral Medicine PLLC /ID# 229713

    New York, New York, 10036

  • Pharmacology Research Inst /ID# 230869

    Newport Beach, California, 92660

  • Sooner Clinical Research /ID# 229731

    Oklahoma City, Oklahoma, 73112

  • Anderson Clinical Research /ID# 230440

    Redlands, California, 92374-4555

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

    Sherman Oaks, California, 91403-2109

  • Viking Clinical Research /ID# 230379

    Temecula, California, 92591-6200

  • Pacific Clinical Research Management Group /ID# 229725

    Upland, California, 91786-3676

  • CincyScience /ID# 229719

    West Chester, Ohio, 45069

  • Grayline Research Center /ID# 230455

    Wichita Falls, Texas, 76309-1608

  • Woodstock Research Center /ID# 231005

    Woodstock, Vermont, 05091-9795

Other trials in United States

About this study

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

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.

Read more

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.

Being tested
Cariprazine 0.75 mg/day, Cariprazine 1.5 mg/day, Cariprazine 3.0 mg/day, Placebo
Keywords
Generalized Anxiety Disorder (GAD), Cariprazine, Vraylar, Depression, Antidepressant therapy
Medical subject headings
Generalized Anxiety Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cariprazine 0.75 mg/dayDrug

    Also called Vraylar

    Oral Capsule

  • Cariprazine 1.5 mg/dayDrug

    Also called Vraylar

    Oral Capsule

  • Cariprazine 3.0 mg/dayDrug

    Also called Vraylar

    Oral Capsule

  • PlaceboOther

    Oral Capsule

Study groups in NCT04965272
Study groupRoleWhat they receive
Cariprazine 0.75 mg/day + Antidepressant TherapyExperimentalAntidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 0.75 mg/day oral, once daily for 6 weeks
Receives: Drug: Cariprazine 0.75 mg/day
Cariprazine 1.5 mg/day + Antidepressant TherapyExperimentalAntidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + cariprazine 1.5 mg/day oral, once daily for 6 weeks
Receives: Drug: Cariprazine 1.5 mg/day
Cariprazine 3.0 mg/day + Antidepressant TherapyExperimentalAntidepressant (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.
Receives: Drug: Cariprazine 3.0 mg/day
Placebo + Antidepressant TherapyPlacebo comparatorAntidepressant (paroxetine, escitalopram, venlafaxine XR, or duloxetine) + oral placebo, once daily for 6 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 6

Secondary outcomes (8)

  1. 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.

    Measured: Week 6

  2. 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

    Measured: Week 6

  3. Percentage of Participants with HAM-A Response

    HAM-A response is defined as >= 50% reduction from baseline in HAM-A total score

    Measured: Week 6

  4. 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).

    Measured: Week 6

  5. 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).

    Measured: Week 6

  6. 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.

    Measured: Week 6

  7. 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.

    Measured: Week 6

  8. 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.

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start18 Aug 2021 (estimated)
  3. Primary completion24 Aug 2021
  4. Study completion24 Aug 2021

Why it stopped: Strategic Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965272
Sponsor's protocol ID
M21-209
Acronym
CAR aGAD Ph 2
Status last verified
Apr 2022
First submitted
7 Jul 2021
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cariprazine 0.75 mg/day, Cariprazine 1.5 mg/day and Cariprazine 3.0 mg/day in people with Generalized Anxiety Disorder, run by AbbVie at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04965272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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