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

Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

Phase 2

Withdrawn

Conditions: Mental Disorder
Bipolar 1 Disorder
Schizophrenia
Nervous System Diseases

Interventions: Drug: Aripiprazole
Device: Ingestible Event Marker (IEM)

First Posted Date: 2013-11-13

Last Posted Date: 2015-04-28

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Registration Number: NCT01981811

A Comparison of Medication Augmentation and PST in the Treatment of Depression in Older Adults

Phase 4

Withdrawn

Conditions: Depressive Disorder Not Otherwise Specified (NOS)
Major Depressive Disorder
Dysthymic Disorder

Interventions: Behavioral: Problem Solving Therapy
Drug: Aripiprazole
Drug: Bupropion

First Posted Date: 2013-09-13

Last Posted Date: 2019-04-18

Lead Sponsor: New York State Psychiatric Institute

Registration Number: NCT01942187

Locations: 🇺🇸
New York State Psychiatric Institute, New York, New York, United States

A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Phase 3

Completed

Conditions: Schizophrenia

Interventions: Drug: Aripiprazole

First Posted Date: 2013-09-13

Last Posted Date: 2017-06-28

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 68

Registration Number: NCT01942148

Antipsychotic Effects on Brain Function in Schizophrenia

Phase 4

Terminated

Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

Interventions: Drug: Aripiprazole
Drug: Risperidone
Drug: Modafinil

First Posted Date: 2013-08-01

Last Posted Date: 2020-04-20

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 4

Registration Number: NCT01913327

Locations: 🇺🇸
University of California, San Francisco, California, United States

A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Phase 4

Terminated

Conditions: Methamphetamine Dependence

Interventions: Drug: Risperidone
Drug: Aripiprazole

First Posted Date: 2013-03-19

Last Posted Date: 2015-02-04

Lead Sponsor: Wei Hao

Target Recruit Count: 50

Registration Number: NCT01813643

Locations: 🇨🇳
The Second Xiangya Hospital of Central University, Changsha, Hunan, China

An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

Phase 4

Terminated

Conditions: Methamphetamine Dependence

Interventions: Drug: Aripiprazole
Drug: placebo

First Posted Date: 2013-03-19

Last Posted Date: 2015-02-04

Lead Sponsor: Wei Hao

Target Recruit Count: 10

Registration Number: NCT01813656

Locations: 🇨🇳
The Second Xiangya Hospital of Central University, Changsha, Hunan, China

A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders

Phase 4

Conditions: Sexual Dysfunction
Hyperprolactinemia

Interventions: Drug: Aripiprazole
Drug: risperidone or paliperidone

First Posted Date: 2012-12-05

Last Posted Date: 2013-03-14

Lead Sponsor: Si Tianmei

Target Recruit Count: 120

Registration Number: NCT01742390

Locations: 🇨🇳
The first hospital of Hebei Province University, Shijiazhuang, Hebei, China
🇨🇳
Institute of mental health, Peking University, Beijing, Beijing, China