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
Public ClinicalTrials.gov record NCT04965272. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04965272
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- Cariprazine 0.75 mg/day Drug
- Cariprazine 1.5 mg/day Drug
- Cariprazine 3.0 mg/day Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 2021 (Estimated)
- Primary completion
- Aug 24, 2021 (Actual)
- Completion
- Aug 24, 2021 (Actual)
- Last update posted
- Apr 12, 2022
2021
United States locations
- U.S. sites
- 36
- U.S. states
- 14
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Preferred Research Partners /ID# 232286 | Little Rock | Arkansas | 72211 | — |
| Axiom Research /ID# 230728 | Colton | California | 92324 | — |
| ATP Clinical Research, Inc /ID# 230445 | Costa Mesa | California | 92626-4607 | — |
| ProScience Research Group /ID# 231520 | Culver City | California | 90230-6632 | — |
| WR-PRI, LLC - Encino /ID# 230434 | Encino | California | 91316 | — |
| Synergy San Diego /ID# 231006 | Lemon Grove | California | 91945-2956 | — |
| Pharmacology Research Institute - Wake LLC /ID# 230722 | Los Alamitos | California | 90720-3500 | — |
| Pharmacology Research Inst /ID# 230869 | Newport Beach | California | 92660 | — |
| 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 | — |
| Galiz Research - Palmetto Medical Plaza /ID# 230446 | Hialeah | Florida | 33016 | — |
| Great Lakes Clinical Trials /ID# 231296 | Chicago | Illinois | 60640 | — |
| Baber Research Group /ID# 230447 | Naperville | Illinois | 60563-6502 | — |
| Boston Clinical Trials /ID# 231003 | Boston | Massachusetts | 02131-2515 | — |
| ActivMed Practices and Research, LLC. /ID# 230441 | Methuen | Massachusetts | 01844 | — |
| Alivation Research /ID# 230449 | Lincoln | Nebraska | 68526-9474 | — |
| Center for Emotional Fitness /ID# 230450 | Cherry Hill | New Jersey | 08002-3008 | — |
| Hassman Research Institute Marlton /ID# 233252 | Marlton | New Jersey | 08053-1930 | — |
| Integrative Clinical Trials /ID# 230955 | Brooklyn | New York | 11229-3576 | — |
| SPRI Clinical Trails /ID# 230957 | Brooklyn | New York | 11235-5660 | — |
| 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 | — |
| Carolina Institute for Clinical Research - Fayetteville /ID# 230961 | Fayetteville | North Carolina | 28303 | — |
| Ohio State Harding Hospital /ID# 231302 | Columbus | Ohio | 43210-1250 | — |
| CincyScience /ID# 229719 | West Chester | Ohio | 45069 | — |
| Sooner Clinical Research /ID# 229731 | Oklahoma City | Oklahoma | 73112 | — |
| Research Strategies of Memphis /ID# 230443 | Memphis | Tennessee | 38119-5202 | — |
| Clinical Neuroscience Solutions - Memphis /ID# 230734 | Memphis | Tennessee | 38119 | — |
| Austin Clinical Trial Partners /ID# 229727 | Austin | Texas | 78737 | — |
| FutureSearch Trials of Dallas, LP /ID# 230535 | Dallas | Texas | 75231 | — |
| Earle Research /ID# 230969 | Houston | Texas | 77058-2746 | — |
| Grayline Research Center /ID# 230455 | Wichita Falls | Texas | 76309-1608 | — |
| Woodstock Research Center /ID# 231005 | Woodstock | Vermont | 05091-9795 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04965272, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2022 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04965272 live on ClinicalTrials.gov.