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Showing 1–24 of 39 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: RGH-188 Clear all
Completed Phase 3 Interventional Results available

Safety and Efficacy of Cariprazine for Mania

NCT01058096
View directory record Official record
Conditions
Bipolar Disorder, Mania
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
323 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
10
States / cities
Long Beach, California • Riverside, California • San Diego, California + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 16, 2017 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

NCT01469377
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Placebo, Cariprazine
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
819 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
39
States / cities
Garden Grove, California • National City, California • Oceanside, California + 34 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2018 · Synced Sep 13, 2026, 2:50 AM EDT
Withdrawn Phase 2 Interventional

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
View directory record Official record
Conditions
Generalized Anxiety Disorder
Interventions
Cariprazine 0.75 mg/day, Cariprazine 1.5 mg/day, Cariprazine 3.0 mg/day, Placebo
Drug · Other
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 65 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
36
States / cities
Little Rock, Arkansas • Colton, California • Costa Mesa, California + 29 more
Source: ClinicalTrials.gov public record
Updated Apr 11, 2022 · Synced Sep 13, 2026, 2:50 AM EDT
Active, not recruiting Phase 4 Interventional

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

NCT06433635
View directory record Official record
Conditions
Bipolar I Disorder, Depression
Interventions
Cariprazine, Aripiprazole/Escitalopram combination, Quetiapine, Lurasidone
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 75 Years
Enrollment
2,726 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
17
States / cities
Birmingham, Alabama • Bloomington, Indiana • Baltimore, Maryland + 13 more
Source: ClinicalTrials.gov public record
Updated Dec 15, 2025 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional

Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD

NCT05439616
View directory record Official record
Conditions
Autism Spectrum Disorder
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
AbbVie
Industry
Eligibility
5 Years to 17 Years
Enrollment
161 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
34
States / cities
Anaheim, California • Imperial, California • Orange, California + 28 more
Source: ClinicalTrials.gov public record
Updated Apr 3, 2025 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03739203
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Cariprazine, Placebo, Antidepressant Therapy (ADT)
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 65 Years
Enrollment
752 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
58
States / cities
Dothan, Alabama • Little Rock, Arkansas • Anaheim, California + 50 more
Source: ClinicalTrials.gov public record
Updated Sep 20, 2022 · Synced Sep 13, 2026, 2:50 AM EDT
Terminated Phase 4 Interventional

An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine

NCT05741502
View directory record Official record
Conditions
Treatment-resistant Schizophrenia
Interventions
Clozapine, Antipsychotics,Other (non-Clozapine)
Drug
Lead sponsor
Ohio State University
Other
Eligibility
18 Years to 65 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 24, 2026 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional

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

NCT04578756
View directory record Official record
Conditions
Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD)
Interventions
Cariprazine Flexible Dose
Drug
Lead sponsor
AbbVie
Industry
Eligibility
5 Years to 17 Years
Enrollment
310 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
40
States / cities
Dothan, Alabama • Bentonville, Arkansas • Anaheim, California + 31 more
Source: ClinicalTrials.gov public record
Updated Oct 26, 2025 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03738215
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 65 Years
Enrollment
759 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
65
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Rogers, Arkansas + 59 more
Source: ClinicalTrials.gov public record
Updated Oct 24, 2022 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 1 Interventional

Cariprazine Pediatric ASD PK Study

NCT04382885
View directory record Official record
Conditions
Autism Spectrum Disorder
Interventions
Cariprazine
Drug
Lead sponsor
AbbVie
Industry
Eligibility
5 Years to 17 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
3
States / cities
Orange, California • Atlanta, Georgia • Decatur, Georgia
Source: ClinicalTrials.gov public record
Updated Apr 11, 2022 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional Results available

Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

NCT01059539
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
Cariprazine
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
403 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
24
States / cities
Springdale, Arkansas • Carson, California • Cerritos, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jun 12, 2019 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

NCT00694707
View directory record Official record
Conditions
Schizophrenia
Interventions
Placebo, Cariprazine, Risperidone
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 60 Years
Enrollment
732 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
18
States / cities
Costa Mesa, California • Long Beach, California • Oceanside, California + 14 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2019 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 2 Interventional Results available

Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

NCT00488618
View directory record Official record
Conditions
Bipolar Disorder
Interventions
Cariprazine (RGH-188), Placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
238 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Apr 13, 2017 · Synced Sep 13, 2026, 2:50 AM EDT
Terminated Phase 3 Interventional Results available

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

NCT03593213
View directory record Official record
Conditions
Schizophrenia
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years to 64 Years
Enrollment
587 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
42
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Rogers, Arkansas + 35 more
Source: ClinicalTrials.gov public record
Updated Apr 10, 2022 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy of Cariprazine for Bipolar I Disorder

NCT01058668
View directory record Official record
Conditions
Mania, Bipolar I Disorder
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
497 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
23
States / cities
Little Rock, Arkansas • Cerritos, California • Costa Mesa, California + 19 more
Source: ClinicalTrials.gov public record
Updated Apr 11, 2017 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

NCT00854100
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Antidepressant + placebo, Antidepressant + cariprazine (0.1-0.3 mg/day), Antidepressant + cariprazine (1-2 mg/d)
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
231 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
41
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Arcadia, California + 35 more
Source: ClinicalTrials.gov public record
Updated Mar 4, 2019 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional Results available

A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

NCT01412060
View directory record Official record
Conditions
Schizophrenia
Interventions
Placebo, Cariprazine
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 60 Years
Enrollment
765 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
25
States / cities
Little Rock, Arkansas • Cerritos, California • Costa Mesa, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 5, 2018 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02670538
View directory record Official record
Conditions
Bipolar Disorder, Depression
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
493 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
42
States / cities
Birmingham, Alabama • Dothan, Alabama • Phoenix, Arizona + 37 more
Source: ClinicalTrials.gov public record
Updated Mar 11, 2019 · Synced Sep 13, 2026, 2:50 AM EDT
Completed No phase listed Observational

A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

NCT04002700
View directory record Official record
Conditions
Stroke
Interventions
Haloperidol, Typical Antipsychotics, Atypical Antipsychotics
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years and older
Enrollment
1,234,412 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
1
States / cities
Titusville, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 24, 2025 · Synced Sep 13, 2026, 2:50 AM EDT
Withdrawn Phase 4 Interventional

Dopamine D3 Receptor Occupancy in Bipolar Depression

NCT05060549
View directory record Official record
Conditions
Bipolar Depression
Interventions
Cariprazine
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 13, 2026 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 3 Interventional Results available

Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

NCT01715805
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Cariprazine, Placebo, Antidepressant Therapy (ADT)
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,022 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
83
States / cities
Tucson, Arizona • Little Rock, Arkansas • Cerritos, California + 68 more
Source: ClinicalTrials.gov public record
Updated Aug 27, 2019 · Synced Sep 13, 2026, 2:50 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

NCT00852202
View directory record Official record
Conditions
Bipolar Depression
Interventions
cariprazine, placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 65 Years
Enrollment
234 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
26
States / cities
Encino, California • Garden Grove, California • National City, California + 23 more
Source: ClinicalTrials.gov public record
Updated Aug 22, 2018 · Synced Sep 13, 2026, 2:50 AM EDT
Terminated Phase 2 Interventional

Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

NCT03430544
View directory record Official record
Conditions
Cocaine Use Disorder
Interventions
Cariprazine Oral Capsule [Vraylar], Placebo oral capsule
Drug
Lead sponsor
Anna Rose Childress, Ph.D.
Other
Eligibility
18 Years to 65 Years
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 8, 2020 · Synced Sep 13, 2026, 2:50 AM EDT
Recruiting Phase 3 Interventional

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

NCT03817502
View directory record Official record
Conditions
Schizophrenia
Interventions
Cariprazine, Placebo
Drug
Lead sponsor
Gedeon Richter Plc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
330 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
9
States / cities
Culver City, California • Atlanta, Georgia • Bloomfield Hills, Michigan + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 7, 2025 · Synced Sep 13, 2026, 2:50 AM EDT