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

Switch Study of Existing Atypical Antipsychotics to Bifeprunox

Phase 3

Completed

Conditions: Schizophrenia and Schizoaffective Disorder

Interventions: Drug: Aripiprazole
Drug: Olanzapine
Drug: Risperidone
Drug: Quetiapine
Drug: Ziprasidone

First Posted Date: 2006-07-04

Last Posted Date: 2008-05-21

Lead Sponsor: Solvay Pharmaceuticals

Target Recruit Count: 286

Registration Number: NCT00347425

Locations: 🇺🇸
Site 180, Kenilworth, New Jersey, United States
🇦🇷
Site 308, Mendoza, Argentina
🇭🇺
Site 212, Gyor, Hungary

and more 119 locations

Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia
Insulin Resistance

Interventions: Drug: Aripiprazole
Drug: Placebo

First Posted Date: 2006-06-27

Last Posted Date: 2014-06-23

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 38

Registration Number: NCT00345033

Locations: 🇺🇸
Massachusetts General Hospital Schizophrenia Program, Boston, Massachusetts, United States

A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Phase 3

Withdrawn

Conditions: Bipolar Disorder

Interventions: Drug: Aripiprazole
Drug: Placebo

First Posted Date: 2006-06-20

Last Posted Date: 2013-11-08

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Registration Number: NCT00338273

Locations: 🇮🇳
Local Institution, Vishakhapatnam, India

Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Phase 3

Completed

Conditions: Behavioral Symptoms
Autistic Disorder

Interventions: Drug: Aripiprazole
Drug: Placebo

First Posted Date: 2006-06-16

Last Posted Date: 2013-12-02

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 218

Registration Number: NCT00337571

Locations: 🇺🇸
Cambridge Health Alliance, Medford, Massachusetts, United States
🇺🇸
Clinical Innovations, Inc., Huntington Beach, California, United States
🇺🇸
University Of Florida, Gainesville, Florida, United States

and more 28 locations

Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Phase 3

Completed

Conditions: Autistic Disorder

Interventions: Drug: Placebo
Drug: Aripiprazole

First Posted Date: 2006-06-01

Last Posted Date: 2013-12-02

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 98

Registration Number: NCT00332241

Locations: 🇺🇸
Univ Of Nc, Chapel Hill, North Carolina, United States
🇺🇸
Neurobehavioral Medicine Group, Bloomfield Hills, Michigan, United States
🇺🇸
Marsella, Gregory, Boca Raton, Florida, United States

and more 6 locations

Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder

Interventions: Drug: Risperidone microspheres
Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Drug: Ziprasidone
Drug: Aripiprazole
Drug: Paliperidone

First Posted Date: 2006-05-29

Last Posted Date: 2018-07-10

Lead Sponsor: Northwell Health

Target Recruit Count: 357

Registration Number: NCT00330863

Locations: 🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
Medical College of Georgia, Department of Psychiatry, Augusta, Georgia, United States
🇺🇸
Harvard Medical School -- Dr. John C. Corrigan Community Mental Health Center, Fall River, Massachusetts, United States

and more 5 locations