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Last Updated: February 7, 2023

CLINICAL TRIALS PROFILE FOR VRAYLAR


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All Clinical Trials for Vraylar

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02670538 ↗ Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder Completed Forest Laboratories Phase 3 2016-03-31 This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT02670551 ↗ Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression Completed Forest Laboratories Phase 3 2016-03-17 This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT02670551 ↗ Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression Completed Forest Laboratories, LLC, an Allergan Affiliate Phase 3 2016-03-17 This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT04771299 ↗ Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients Recruiting Jayasree Basivireddy Phase 3 2021-07-07 Some patients with bipolar disorder show broad cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.) that persist during euthymia (no symptoms of depression or mania) despite remission of mood symptoms. Cognitive deficits (significant cognitive impairments) in bipolar disorder are associated with impairments in everyday functioning and quality of life. Thus, improving cognitive functioning is an important treatment goal in people with bipolar disorder. In a recent study, investigators have demonstrated that lurasidone; an atypical antipsychotic was more effective than treatment as usual in improving cognition. The study will examine the efficacy of Cariprazine (VRAYLAR┬«) in improving cognition in patients with bipolar disorder. Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder. This study is a randomized (like the flip of a coin), double-blind (participant and the study team will not know which treatment arm participant will receive) study in which 30 participants will be randomized across two sites in Canada.
NCT04777357 ↗ A Study of the Change in Disease State and Safety of Oral Cariprazine Capsules in the Treatment of Depression in Pediatric Participants (10 to 17 Years of Age) With Bipolar I Disorder Recruiting Allergan Phase 3 2021-04-28 Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly 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.
NCT04965272 ↗ 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 Withdrawn Allergan Phase 2 2021-08-18 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vraylar

Condition Name

Condition Name for Vraylar
Intervention Trials
Depression 3
Bipolar Disorder 2
Bipolar I Disorder 2
Autism Spectrum Disorder 1
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Condition MeSH

Condition MeSH for Vraylar
Intervention Trials
Depressive Disorder 4
Depression 4
Disease 4
Bipolar Disorder 3
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Clinical Trial Locations for Vraylar

Trials by Country

Trials by Country for Vraylar
Location Trials
United States 69
Japan 20
Serbia 4
Romania 4
Bulgaria 3
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Trials by US State

Trials by US State for Vraylar
Location Trials
New York 6
Texas 4
Oklahoma 4
Ohio 4
New Jersey 4
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Clinical Trial Progress for Vraylar

Clinical Trial Phase

Clinical Trial Phase for Vraylar
Clinical Trial Phase Trials
Phase 4 2
Phase 3 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Vraylar
Clinical Trial Phase Trials
Not yet recruiting 4
Completed 2
Recruiting 2
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Clinical Trial Sponsors for Vraylar

Sponsor Name

Sponsor Name for Vraylar
Sponsor Trials
AbbVie 3
Forest Laboratories 2
Allergan 2
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Sponsor Type

Sponsor Type for Vraylar
Sponsor Trials
Industry 8
Other 3
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