Aripiprazole

Generic Name: Aripiprazole

Brand Names: Abilify, Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), Abilify Maintena, Aripiprazole Accord, Aripiprazole Sandoz, Aripiprazole Zentiva

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₇Cl_₂N_₃O_₂

CAS Number: 129722-12-9

Unique Ingredient Identifier: 82VFR53I78

Background: Aripiprazole is an atypical antipsychotic orally indicated for the treatment of schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's. It is also indicated as an injection for agitation associated with schizophrenia or bipolar mania. Aripiprazole exerts its effects through agonism of dopaminergic and 5-HT1A receptors and antagonism of alpha-adrenergic and 5-HT2A receptors. Aripiprazole was given FDA approval on November 15, 2002.

Indication: Aripiprazole is indicated for the treatment of acute manic and mixed episodes associated with bipolar I disorder, irritability associated with autism spectrum disorder, schizophrenia, and Tourette's disorder. It is also used as an adjunctive treatment of major depressive disorder.[L45859 An injectable formulation of aripiprazole is indicated for agitation associated with schizophrenia or bipolar mania. Finally, an extended-release, bimonthly injection formulation of aripiprazole is indicated for the treatment of adult schizophrenia and maintenance therapy for adult bipolar I disorder.

Associated Conditions: Agitation, Bipolar 1 Disorder, Irritability, Major Depressive Disorder (MDD), Mixed manic depressive episode, Psychosis, Psychotic Depression, Schizophrenia, Tourette's Disorder (TD), Acute Manic episode

Associated Therapies: Monotherapy

Clinical Trials

Identification of Multi-modal Bio-markers for Early Diagnosis and Treatment Prediction in Schizophrenia Individuals

Early Phase 1

Conditions: Schizophrenia
Major Depressive Disorder
Anxiety Disorders

Interventions: Drug: Risperidone
Drug: Olanzapine
Drug: Aripiprazole

First Posted Date: 2018-12-31

Last Posted Date: 2018-12-31

Lead Sponsor: Tianjin Medical University General Hospital

Target Recruit Count: 2700

Registration Number: NCT03790085

Locations: 🇨🇳
Tianjin Medical University General Hospital, Tianjin, China

Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder

Phase 4

Terminated

Conditions: Tourette's Disorder (TD)

Interventions: Drug: Placebo
Drug: Aripiprazole

First Posted Date: 2018-09-07

Last Posted Date: 2021-03-09

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 36

Registration Number: NCT03661983

Locations: 🇺🇸
Reliable Clinical Research, Hialeah, Florida, United States
🇺🇸
Pediatric and Adolescent Neurodevelopment Associates, Atlanta, Georgia, United States
🇺🇸
Alivation, Lincoln, Nebraska, United States

and more 39 locations

A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

Phase 4

Terminated

Conditions: Schizophrenia
Bipolar 1 Disorder
Major Depressive Disorder

Interventions: Combination Product: Abilify MyCite - Digital Medicine System
Drug: Aripiprazole or other oral antipsychotics

First Posted Date: 2018-08-22

Last Posted Date: 2019-11-08

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 2

Registration Number: NCT03643159

Locations: 🇺🇸
Psychiatric Addiction Curative/PACT Atlanta LLC, Decatur, Georgia, United States
🇺🇸
Kolade Research Institute, Las Vegas, Nevada, United States
🇺🇸
Georgia Psychiatry and Sleep, Smyrna, Georgia, United States

and more 2 locations

A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder
First Episode Psychosis

Interventions: Device: Digital Medicine System
Drug: Aripiprazole
Drug: Olanzapine
Drug: Quetiapine
Drug: Risperidone

First Posted Date: 2018-06-26

Last Posted Date: 2020-07-16

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 44

Registration Number: NCT03568500

Locations: 🇬🇧
Clinical Trial Site, Southampton, United Kingdom

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

Phase 2

Completed

Conditions: Schizophrenia

Interventions: Drug: ASP4345
Drug: placebo
Drug: risperidone
Drug: quetiapine
Drug: olanzapine
Drug: ziprasidone
Drug: aripiprazole
Drug: brexpiprazole
Drug: paliperidone
Drug: lurasidone

First Posted Date: 2018-06-15

Last Posted Date: 2024-11-11

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 233

Registration Number: NCT03557931

Locations: 🇺🇸
CNS Research Science, Inc., Jamaica, New York, United States
🇺🇸
Synergy East, Lemon Grove, California, United States
🇺🇸
Pacific Research Partners, LLC, Oakland, California, United States

and more 22 locations

Long-term Antipsychotic Pediatric Safety Trial

Completed

Conditions: Weight, Body

Interventions: Drug: Risperidone
Drug: Aripiprazole

First Posted Date: 2018-05-11

Last Posted Date: 2024-07-10

Lead Sponsor: Duke University

Target Recruit Count: 509

Registration Number: NCT03522168

Locations: 🇺🇸
UCLA Semel Institute, Los Angeles, California, United States
🇺🇸
Beacon Medical Group, South Bend, Indiana, United States
🇺🇸
Carolina Partners in Mental HealthCare, PLLC, Raleigh, North Carolina, United States

and more 34 locations

Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome

Phase 3

Completed

Conditions: Tourette Syndrome

Interventions: Drug: Aripiprazole Oral Solution
Drug: Placebo Oral Solution

First Posted Date: 2018-04-04

Last Posted Date: 2020-12-29

Lead Sponsor: Otsuka Beijing Research Institute

Target Recruit Count: 121

Registration Number: NCT03487783

Locations: 🇨🇳
Beijing Anding Hospital of Capital Medical University, Beijing, Beijing, China

Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder

Phase 3

Completed

Conditions: Autistic Disorder

Interventions: Drug: Placebo Oral Solution
Drug: Aripiprazole Oral Solution

First Posted Date: 2018-04-04

Last Posted Date: 2020-12-29

Lead Sponsor: Otsuka Beijing Research Institute

Target Recruit Count: 111

Registration Number: NCT03487770

Locations: 🇨🇳
6th affiliated hospital, Peking University, Beijing, Beijing, China

Substance Misuse To Psychosis for Stimulants

Phase 2

Recruiting

Conditions: Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis)
Schizophrenia and Related Disorders
Stimulant Dependence
Stimulant Abuse
Pharmacotherapy

Interventions: Drug: Paliperidone
Other: Treatment as Usual
Drug: Aripiprazole

First Posted Date: 2018-04-02

Last Posted Date: 2023-07-05

Lead Sponsor: The University of Hong Kong

Target Recruit Count: 240

Registration Number: NCT03485417

Locations: 🇭🇰
Queen Mary Hospital, Hong Kong, Hong Kong

A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression

Phase 3

Recruiting

Conditions: Depression, Bipolar

Interventions: Drug: Abilify 2, 5, 10, 15mg (Tablet)
Drug: Placebo of Abilify 2, 5, 10, 15mg (Tablet)

First Posted Date: 2018-02-06

Last Posted Date: 2024-08-19

Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 390

Registration Number: NCT03423680

Locations: 🇰🇷
Seounl National University Hospital, Seoul, Korea, Republic of

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