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Olanzapine

Generic Name
Olanzapine
Brand Names
Lybalvi, Olazax, Symbyax, Zalasta, Zypadhera, Zyprexa, Olanzapine Glenmark Europe, Olanzapine Apotex, Olanzapine Teva, Olazax Disperzi, Olanzapine Mylan, Zyprexa Velotab, Olanzapine Glenmark
Drug Type
Small Molecule
Chemical Formula
C17H20N4S
CAS Number
132539-06-1
Unique Ingredient Identifier
N7U69T4SZR
Background

Olanzapine is a thienobenzodiazepine classified as an atypical or second-generation antipsychotic agent. The second-generation antipsychotics were introduced in the 90s and quickly gained traction due to their impressive efficacy, reduced risk for extrapyramidal side effects and reduced susceptibility to drug-drug interactions. Olanzapine very closely resembles clozapine and only differs by two additional methyl groups and the absence of a chloride moiety. It was discovered by scientists at Eli Lilly and approved to be marketed in the US in 1996.

Indication

Olanzapine was initially used orally and intramuscularly for the chronic treatment of schizophrenia in patients over 13 years old and other psychiatric disorders such as bipolar I disorder including mixed or manic episodes.

Olanzapine is also indicated, in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults.

As well, olanzapine is indicated, in combination with fluoxetine for the treatment of episodes of depression associated with bipolar disorder type 1 and treatment-resistant depression in patients over 10 years old.

Olanzapine is also approved for the management of psychomotor agitation associated with schizophrenia and bipolar I mania.

Schizophrenia is a complex biochemical brain disorder that affects the person's ability to differentiate reality. It is usually observed as the presence of delusions, hallucinations, social withdrawal and disturbed thinking.

Bipolar disorder is a mental health condition defined by periods of extreme mood disturbances. It is categorized in different types from which type 1 is known to involve episodes of severe mania and often depression while type 2 presents less severe forms of mania.

Olanzapine is also indicated in combination with samidorphan for the treatment of bipolar I disorder, either as an adjunct to lithium or valproate or as monotherapy for the acute treatment of manic or mixed episodes or as maintenance therapy, and for the treatment of schizophrenia in adults.

Associated Conditions
Acute Agitation, Bipolar 1 Disorder, Bipolar Disorder With Manic or Mixed Episodes, Delirium, Delusional Parasitosis, Depressive Episodes, Gilles de la Tourette's Syndrome, Major depressive disorder, recurrent episode, Mixed manic depressive episode, Post Traumatic Stress Disorder (PTSD), Psychosis, Schizophrenia, Acute Manic episode

Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

Phase 4
Completed
Conditions
Depression, Bipolar
First Posted Date
2005-09-19
Last Posted Date
2007-01-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
150
Registration Number
NCT00191399
Locations
🇵🇷

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Santurce, Puerto Rico

🇵🇷

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Hato Rey, Puerto Rico

A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme

Phase 4
Completed
Conditions
Weight Gain
First Posted Date
2005-09-19
Last Posted Date
2007-01-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
60
Registration Number
NCT00191828
Locations
🇮🇹

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speack with your personal physician., Sesto Fiorentino, Florence, Italy

Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

Phase 3
Terminated
Conditions
Bipolar Disorder
Interventions
First Posted Date
2005-09-19
Last Posted Date
2016-10-04
Lead Sponsor
University Hospitals Cleveland Medical Center
Target Recruit Count
18
Registration Number
NCT00194064
Locations
🇺🇸

University Hospitals of Cleveland, Cleveland, Ohio, United States

Optimal Length of Treatment Continuation With Olanzapine After Remission of Manic or Mixed Episode

Phase 4
Completed
Conditions
Bipolar Disorder
First Posted Date
2005-09-19
Last Posted Date
2006-07-25
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
180
Registration Number
NCT00191997
Locations
🇪🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Zamora, Spain

Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents

Not Applicable
Terminated
Conditions
Bipolar Disorder
Psychotic Disorders
First Posted Date
2005-09-16
Last Posted Date
2014-01-08
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
68
Registration Number
NCT00183612
Locations
🇺🇸

Cambridge Health Alliance, Medford, Massachusetts, United States

🇺🇸

McLean Hospital, Belmont, Massachusetts, United States

Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

Phase 4
Completed
Conditions
Bipolar Spectrum Disorder
First Posted Date
2005-09-16
Last Posted Date
2013-06-13
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
106
Registration Number
NCT00182013

Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients

Phase 4
Completed
Conditions
Schizophrenia
Interventions
Behavioral: Individual Placement and Support (Supported Employment)
Behavioral: Social Skills Training
First Posted Date
2005-09-16
Last Posted Date
2015-06-10
Lead Sponsor
University of California, Los Angeles
Target Recruit Count
107
Registration Number
NCT00183625
Locations
🇺🇸

West Los Angeles Veterans Healthcare Center, Los Angeles, California, United States

🇺🇸

Greater Manchester Mental Health Center, Manchester, New Hampshire, United States

A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder

Phase 4
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Fluoxetine+Olanzapine
Procedure: Functional Magnetic Resonance Imaging
First Posted Date
2005-09-16
Last Posted Date
2013-02-08
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
42
Registration Number
NCT00188942
Locations
🇨🇦

University Health Network - Toronto General Division, Toronto, Ontario, Canada

🇨🇦

University Health Network - Toronto Western Division, Toronto, Ontario, Canada

Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder

Phase 4
Completed
Conditions
Mania
Bipolar Disorder
First Posted Date
2005-09-16
Last Posted Date
2013-05-06
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
40
Registration Number
NCT00181935
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Cognition, Functioning and Quality of Life

Phase 4
Completed
Conditions
Schizophrenia
First Posted Date
2005-09-16
Last Posted Date
2006-10-11
Lead Sponsor
Hamilton Health Sciences Corporation
Target Recruit Count
80
Registration Number
NCT00182442
Locations
🇨🇦

McMaster University, Hamilton, Ontario, Canada

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