Risperidone

Generic Name
Risperidone
Brand Names
Perseris, Risperdal, Rykindo, Uzedy, Okedi
Drug Type
Small Molecule
Chemical Formula
C23H27FN4O2
CAS Number
106266-06-2
Unique Ingredient Identifier
L6UH7ZF8HC
Background

Risperidone is a second-generation antipsychotic (SGA) medication used in the treatment of a number of mood and mental health conditions including schizophrenia and bipolar disorder. It is one of the most widely used SGAs. Paliperidone, another commonly used SGA, is the primary active metabolite of risperidone (i.e. 9-hydroxyrisperidone).

Schizophrenia and various mood disorders are thought to be caused by an excess of dopaminergic D2 and serotonergic 5-HT2A activity, resulting in overactivity of central mesolimbic pathways and mesocortical pathways, respectively. Risperidone is thought to reduce this overactivity through inhibition of dopaminergic D2 receptors and serotonergic 5-HT2A receptors in the brain.

Risperidone binds with a very high affinity to 5-HT2A receptors, approximately 10-20 fold greater than the drug's binding affinity to D2 receptors, and carries lesser activity at several off-targets which may responsible for some of its undesirable effects.

Indication

Risperidone is indicated for the treatment of schizophrenia and irritability associated with autistic disorder. It is also indicated as monotherapy, or adjunctly with lithium or valproic acid, for the treatment of acute mania or mixed episodes associated with bipolar I disorder.

Risperidone is additionally indicated in Canada for the short-term symptomatic management of aggression or psychotic symptoms in patients with severe dementia of the Alzheimer type unresponsive to nonpharmacological approaches.

Risperidone is also used off-label for a number of conditions including as an adjunct to antidepressants in treatment-resistant depression.

Associated Conditions
Acute Mania, Irritability, Mixed manic depressive episode, Psychosis, Schizophrenia, Acute Manic episode, Agitated psychotic state
Associated Therapies
-

Comparison of the Efficacy and Safety of Risperidone Versus Risperidone Plus Low Dose of Haloperidol in the Treatment of Schizophrenia

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2009-10-20
Last Posted Date
2009-10-20
Lead Sponsor
Kaohsiung Kai-Suan Psychiatric Hospital
Target Recruit Count
88
Registration Number
NCT00998608
Locations
🇨🇳

Kai-Suan Psychiatric Hospital, Kaohsiung, Taiwan

Bioequivalence Study of Risperidone 1 mg Tablets of Torrent Pharmaceuticals Limited, India and Risperdal® (Risperidone) 1 mg Tablets of Janssen Pharmaceutical Products, LP, USA, in Healthy Human Adult Subjects, Under Fed Conditions

Phase 1
Completed
Conditions
First Posted Date
2009-07-15
Last Posted Date
2017-10-24
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT00939926
Locations
🇮🇳

Lotus Labs Pvt. Ltd., Bangalore, Karnataka, India

Bioequivalence Study of Risperidone 1.0 mg Tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1.0 mg Tablets of Janssen Pharmaceutical Products, LP, USA, in Healthy Human Adult Subjects, Under Fasting Conditions

Phase 1
Completed
Conditions
First Posted Date
2009-07-15
Last Posted Date
2017-10-24
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT00939497
Locations
🇮🇳

Lotus Labs Pvt. Ltd., Bangalore, Karnataka, India

Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning

First Posted Date
2009-07-10
Last Posted Date
2010-10-28
Lead Sponsor
University of California, Irvine
Target Recruit Count
96
Registration Number
NCT00937261
Locations
🇺🇸

UC Irvine, Irvine, California, United States

Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting

First Posted Date
2009-07-03
Last Posted Date
2010-05-25
Lead Sponsor
University of Bergen
Target Recruit Count
226
Registration Number
NCT00932529
Locations
🇳🇴

Haukeland University Hospital, Division of Psychiatry, Bergen, Sandviken, Norway

Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients

First Posted Date
2009-06-16
Last Posted Date
2010-06-30
Lead Sponsor
AstraZeneca
Target Recruit Count
296
Registration Number
NCT00921804
Locations
🇺🇸

Research Site, Rockville, Maryland, United States

Metabolic Effects of Antipsychotic Substitution in Children

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2009-06-01
Last Posted Date
2014-03-13
Lead Sponsor
Washington University School of Medicine
Registration Number
NCT00910780

Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia

First Posted Date
2009-05-05
Last Posted Date
2009-05-05
Lead Sponsor
National Institute of Mental Health and Neuro Sciences, India
Target Recruit Count
48
Registration Number
NCT00893256
Locations
🇮🇳

National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, Karnataka, India

Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-03-06
Last Posted Date
2011-08-19
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
9809
Registration Number
NCT00856583
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