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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
C23H27Cl2N3O2
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

CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)

Phase 4
Completed
Conditions
Medication Non Adherence
Medication Adherence
Bipolar Disorder
Interventions
Behavioral: Customized Adherence Enhancement (CAE)
First Posted Date
2018-01-24
Last Posted Date
2022-02-17
Lead Sponsor
Martha Sajatovic
Target Recruit Count
30
Registration Number
NCT03408873
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics

Phase 4
Completed
Conditions
Long-Acting Injection
LAI
Aripiprazole
Schizophrenia
Antipsychotics
Interventions
First Posted Date
2017-12-18
Last Posted Date
2021-12-17
Lead Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
201
Registration Number
NCT03376763
Locations
🇰🇷

Cha Bundang Medical Center, Seongnam-si, Gyeonggi-do, Korea, Republic of

🇰🇷

Eulji University Hospital, Daejeon, Korea, Republic of

🇰🇷

Kangbuk Samsung Hospital, Seoul, Korea, Republic of

and more 24 locations

Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults

Phase 1
Completed
Conditions
Healthy Male Adults
Interventions
First Posted Date
2017-11-17
Last Posted Date
2021-05-03
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
74
Registration Number
NCT03342963
Locations
🇯🇵

Clinic of Kyusyu Region, Fukuoka, Japan

Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study

Phase 4
Completed
Conditions
Acute Schizophrenia Episode
Interventions
First Posted Date
2017-09-20
Last Posted Date
2021-02-05
Lead Sponsor
Peking University
Target Recruit Count
770
Registration Number
NCT03289026
Locations
🇨🇳

Beijing Anding Hospital, Capital Medical University, Beijing, Beijing, China

🇨🇳

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

🇨🇳

Shandong Mental Health Center, Jinan, Shandong, China

and more 9 locations

Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Phase 1
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2017-09-19
Last Posted Date
2020-12-29
Lead Sponsor
Otsuka Beijing Research Institute
Target Recruit Count
24
Registration Number
NCT03287505
Locations
🇨🇳

Beijing Anding Hospital of Capital Medical University, Beijing, Beijing, China

PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Phase 1
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2017-09-18
Last Posted Date
2020-07-10
Lead Sponsor
Otsuka Beijing Research Institute
Target Recruit Count
12
Registration Number
NCT03285503
Locations
🇨🇳

Beijing Anding Hospital of Capital Medical University, Beijing, Beijing, China

Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition

Not Applicable
Conditions
Bioequivalence
Interventions
Drug: Bosiqing
First Posted Date
2017-07-28
Last Posted Date
2017-07-28
Lead Sponsor
Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Target Recruit Count
66
Registration Number
NCT03232710
Locations
🇨🇳

West China Hospital of Sichuan University, Chengdu, Sichuan, China

Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2017-06-23
Last Posted Date
2023-12-20
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
316
Registration Number
NCT03198078
Locations
🇺🇸

For additional information regarding sites, contact 844-687-8522, Oklahoma City, Oklahoma, United States

Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

Completed
Conditions
Autism
First Posted Date
2017-06-07
Last Posted Date
2021-09-16
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
528
Registration Number
NCT03179787
Locations
🇯🇵

Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan

Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2017-06-01
Last Posted Date
2020-12-29
Lead Sponsor
Otsuka Beijing Research Institute
Target Recruit Count
436
Registration Number
NCT03172871
Locations
🇨🇳

Beijing Anding Hospital of Capital Medical University, Beijing, Beijing, China

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