Cariprazine

Generic Name: Cariprazine

Brand Names: Vraylar, Reagila

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₃₂Cl_₂N_₄O

CAS Number: 839712-12-8

Unique Ingredient Identifier: F6RJL8B278

Background: Cariprazine is an atypical antipsychotic agent and a piperazine derivative that was first developed in Hungary. It works as a partial agonist at central dopamine D2, dopamine D3, and serotonin 5-HT receptors and as an antagonist at serotonin 5-HT receptors. Cariprazine has been investigated in a variety of psychiatric disorders, including schizophrenia, bipolar disorders, and major depressive disorder. Cariprazine gained its first global approval in the US in September 2015 and was later approved by Health Canada in April 2022. It is currently used to treat schizophrenia, and manic or mixed episodes and depressive episodes associated with bipolar I disorder.

Indication: Cariprazine is indicated for the treatment of schizophrenia in adults to manage both positive and negative symptoms. It is also indicated to monotherapy for acute management of manic or mixed episodes associated with bipolar I disorder (bipolar mania) in adults, and acute management of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

Associated Conditions: Bipolar Disorder With Manic or Mixed Episodes, Depressive Episodes, Schizophrenia

Clinical Trials

A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

Phase 3

Recruiting

Conditions: Depression
Bipolar I Disorder

Interventions: Drug: Placebo
Drug: Cariprazine

First Posted Date: 2021-03-02

Last Posted Date: 2025-04-09

Lead Sponsor: AbbVie

Target Recruit Count: 380

Registration Number: NCT04777357

Locations: 🇺🇸
Pillar Clinical Research /ID# 226504, Bentonville, Arkansas, United States
🇺🇸
Advanced Research Center /ID# 227073, Anaheim, California, United States
🇺🇸
Care Access Research /ID# 226316, Beverly Hills, California, United States

and more 67 locations

Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients

Phase 3

Terminated

Conditions: Cognitive Impairment
Bipolar I Disorder

Interventions: Other: Placebo
Drug: Cariprazine

First Posted Date: 2021-02-25

Last Posted Date: 2024-10-26

Lead Sponsor: Lakshmi N Yatham

Target Recruit Count: 1

Registration Number: NCT04771299

Locations: 🇨🇦
Djavad Mowfaghian Centre for Brain Heath, Vancouver, British Columbia, Canada

Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

Phase 3

Active, not recruiting

Conditions: Schizophrenia
Autism Spectrum Disorder (ASD)
Bipolar I Disorder

Interventions: Drug: Cariprazine Flexible Dose

First Posted Date: 2020-10-08

Last Posted Date: 2024-10-18

Lead Sponsor: AbbVie

Target Recruit Count: 310

Registration Number: NCT04578756

Locations: 🇺🇸
Harmonex Neuroscience Research /ID# 234938, Dothan, Alabama, United States
🇺🇸
Pillar Clinical Research /ID# 236434, Bentonville, Arkansas, United States
🇺🇸
Advanced Research Center /ID# 241903, Anaheim, California, United States

and more 39 locations

Cariprazine Pediatric ASD PK Study

Phase 1

Completed

Conditions: Autism Spectrum Disorder

Interventions: Drug: Cariprazine

First Posted Date: 2020-05-11

Last Posted Date: 2022-04-12

Lead Sponsor: AbbVie

Target Recruit Count: 24

Registration Number: NCT04382885

Locations: 🇺🇸
Atlanta Center for Medical Research /ID# 233576, Atlanta, Georgia, United States
🇺🇸
iResearch Atlanta, LLC /ID# 233614, Decatur, Georgia, United States
🇺🇸
Neuropsychiatric Research Center of Orange County /ID# 233663, Orange, California, United States

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

Phase 3

Recruiting

Conditions: Schizophrenia

Interventions: Drug: Placebo
Drug: Cariprazine

First Posted Date: 2019-01-25

Last Posted Date: 2024-12-17

Lead Sponsor: Gedeon Richter Plc.

Target Recruit Count: 330

Registration Number: NCT03817502

Locations: 🇷🇺
SBHI of Moscow Region "Central Clinical Psychiatric Hospital", Moscow, Russian Federation
🇷🇺
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod, Nizhny Novgorod, Russian Federation
🇷🇺
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary, Roshchino, Russian Federation

and more 54 locations

Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Placebo
Drug: Cariprazine

First Posted Date: 2018-11-13

Last Posted Date: 2022-10-25

Lead Sponsor: AbbVie

Target Recruit Count: 759

Registration Number: NCT03738215

Locations: 🇺🇸
Lehigh Center for Clinical Research /ID# 236702, Allentown, Pennsylvania, United States
🇺🇸
Hassman Research Institute /ID# 237501, Berlin, New Jersey, United States
🇺🇸
Psych Atlanta /ID# 235835, Marietta, Georgia, United States

and more 122 locations

The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Placebo
Drug: Cariprazine
Drug: Antidepressant Therapy (ADT)

First Posted Date: 2018-11-13

Last Posted Date: 2022-09-21

Lead Sponsor: AbbVie

Target Recruit Count: 752

Registration Number: NCT03739203

Locations: 🇺🇸
Global Clinical Trials /ID# 235059, Costa Mesa, California, United States
🇺🇸
Institute for Advanced Medical Research /ID# 234992, Atlanta, Georgia, United States
🇺🇸
International Research Associates, LLC /ID# 237410, Miami, Florida, United States

and more 109 locations

Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia

Phase 3

Terminated

Conditions: Schizophrenia

Interventions: Drug: Placebo
Drug: Cariprazine

First Posted Date: 2018-07-20

Last Posted Date: 2022-04-11

Lead Sponsor: AbbVie

Target Recruit Count: 587

Registration Number: NCT03593213

Locations: 🇺🇸
Advanced Research Center, Inc., Anaheim, California, United States
🇺🇸
California Pharmaceutical Research Institute, Inc., Costa Mesa, California, United States
🇺🇸
Collaborative Neuroscience Research, LLC, Torrance, California, United States

and more 92 locations

A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Phase 3

Completed

Conditions: Bipolar I Disorder
Mania
Depression

Interventions: Drug: Cariprazine
Drug: Placebo

First Posted Date: 2018-06-29

Last Posted Date: 2023-09-28

Lead Sponsor: AbbVie

Target Recruit Count: 901

Registration Number: NCT03573297

Locations: 🇺🇸
Synexus Clinical Research, Inc /ID# 232950, Atlanta, Georgia, United States
🇺🇸
Atlanta Center for Medical Research /ID# 232832, Atlanta, Georgia, United States
🇺🇸
NRC Research Institute /ID# 232741, Orange, California, United States

and more 105 locations

Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

Phase 2

Terminated

Conditions: Cocaine Use Disorder

Interventions: Drug: Cariprazine Oral Capsule [Vraylar]
Drug: Placebo oral capsule

First Posted Date: 2018-02-13

Last Posted Date: 2020-09-09

Lead Sponsor: Anna Rose Childress, Ph.D.

Target Recruit Count: 14

Registration Number: NCT03430544

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

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