MedPath

Quetiapine

Generic Name
Quetiapine
Brand Names
Seroquel
Drug Type
Small Molecule
Chemical Formula
C21H25N3O2S
CAS Number
111974-69-7
Unique Ingredient Identifier
BGL0JSY5SI
Background

Initially approved by the FDA in 1997, quetiapine is a second-generation atypical antipsychotic used in schizophrenia, major depression, and bipolar disorder. Quetiapine demonstrates a high level of therapeutic efficacy and low risk of adverse effects during long-term treatment. It is well-tolerated and a suitable option for some patients with high sensitivity to other drugs, such as Clozapine and Olanzapine.

Indication

Quetiapine is used in the symptomatic treatment of schizophrenia. In addition, it may be used for the management of acute manic or mixed episodes in patients with bipolar I disorder, as a monotherapy or combined with other drugs. It may be used to manage depressive episodes in bipolar disorder. In addition to the above indications, quetiapine is used in combination with antidepressant drugs for the treatment of major depression.

Some off-label uses for this drug include the management of post-traumatic stress disorder (PTSD), generalized anxiety disorder, and psychosis associated with Parkinson's disease.

Associated Conditions
Bipolar 1 Disorder, Depressive Episodes, Generalized Anxiety Disorder, Major Depressive Disorder (MDD), Mixed manic depressive episode, Post Traumatic Stress Disorder (PTSD), Psychosis, Schizophrenia, Acute Manic episode

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

Phase 2
Completed
Conditions
Depressive Disorder, Major
Interventions
First Posted Date
2020-08-20
Last Posted Date
2025-03-06
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
389
Registration Number
NCT04521478
Locations
🇺🇸

CT Clinical Research, Cromwell, Connecticut, United States

🇺🇸

Institute of Living, Hartford, Connecticut, United States

🇺🇸

Gulf Coast Clinical Research Center, Fort Myers, Florida, United States

and more 117 locations

Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium

Phase 4
Withdrawn
Conditions
Covid19
Pneumonia, Viral
Hyperactive Delirium
Interventions
Other: Standard of Care
First Posted Date
2020-08-14
Last Posted Date
2023-03-31
Lead Sponsor
University of Miami
Registration Number
NCT04513314

A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

First Posted Date
2020-08-14
Last Posted Date
2025-04-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
757
Registration Number
NCT04513912
Locations
🇵🇱

Centrum Badan Klinicznych PI House sp z o o, Gdansk, Poland

🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

SW Biomedical Research LLC, Tucson, Arizona, United States

and more 166 locations

Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building

First Posted Date
2020-06-24
Last Posted Date
2020-08-26
Lead Sponsor
Shanghai Mental Health Center
Target Recruit Count
350
Registration Number
NCT04446234
Locations
🇨🇳

CHINA, Shanghai, Minhang, China

Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

Phase 4
Recruiting
Conditions
Parkinson's Disease Psychosis
Interventions
First Posted Date
2020-05-04
Last Posted Date
2024-07-16
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
358
Registration Number
NCT04373317
Locations
🇺🇸

Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas, United States

🇺🇸

Southern Arizona VA Health Care System, Tucson, AZ, Tucson, Arizona, United States

🇺🇸

South Texas Health Care System, San Antonio, TX, San Antonio, Texas, United States

and more 22 locations

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

First Posted Date
2020-04-08
Last Posted Date
2025-04-29
Lead Sponsor
Janssen-Cilag International NV
Target Recruit Count
676
Registration Number
NCT04338321
Locations
🇧🇷

Ruschel Medicina e Pesquisa Clínica Ltda, Rio de Janeiro, Brazil

🇧🇷

C J S Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana), Sao Paulo, Brazil

🇧🇷

BR Trials, Sao Paulo, Brazil

and more 165 locations

Quetiapine Augmentation of PE Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury

Early Phase 1
Completed
Conditions
Post Traumatic Stress Disorder
Interventions
Other: Standard of care meducations
First Posted Date
2020-02-21
Last Posted Date
2023-05-09
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
28
Registration Number
NCT04280965
Locations
🇺🇸

UT Health San Antonio, San Antonio, Texas, United States

Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

Phase 2
Terminated
Conditions
Parkinson's Disease
Interventions
First Posted Date
2019-11-15
Last Posted Date
2021-10-14
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
11
Registration Number
NCT04164758
Locations
🇺🇸

Movement Disorders Center of Arizona, Scottsdale, Arizona, United States

🇺🇸

Tucson Neuroscience Research, Tucson, Arizona, United States

🇺🇸

Galiz Research, Hialeah, Florida, United States

and more 12 locations

A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2019-10-04
Last Posted Date
2024-06-28
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
475
Registration Number
NCT04115319
Locations
🇷🇴

Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII, Bucuresti, Romania

🇷🇺

Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1", Saint Petersburg, Russian Federation

🇷🇺

State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2", Stavropol, Russian Federation

and more 43 locations

Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder

First Posted Date
2019-03-13
Last Posted Date
2020-09-02
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
58
Registration Number
NCT03872596
Locations
🇺🇸

Collaborative Neurosciences Network, LLC, Long Beach, California, United States

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