Quetiapine

Generic Name: Quetiapine

Brand Names: Seroquel

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₅N_₃O_₂S

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

Clinical Trials

Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients

Phase 3

Terminated

Conditions: Postoperative Delirium

Interventions: Drug: Quetiapine 25 milligrams capsule
Drug: Placebo oral capsule

First Posted Date: 2018-11-13

Last Posted Date: 2022-06-14

Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Target Recruit Count: 50

Registration Number: NCT03739476

Locations: 🇪🇸
Complejo Asistencial Universitario de Salamanca, Salamanca, Spain

Quetiapine Treatment for Pediatric Delirium

Phase 2

Withdrawn

Conditions: Delirium

Interventions: Other: Placebo
Drug: Quetiapine

First Posted Date: 2018-06-28

Last Posted Date: 2020-04-08

Lead Sponsor: Medical College of Wisconsin

Registration Number: NCT03572257

Locations: 🇺🇸
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder
First Episode Psychosis

Interventions: Device: Digital Medicine System
Drug: Aripiprazole
Drug: Olanzapine
Drug: Quetiapine
Drug: Risperidone

First Posted Date: 2018-06-26

Last Posted Date: 2020-07-16

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Target Recruit Count: 44

Registration Number: NCT03568500

Locations: 🇬🇧
Clinical Trial Site, Southampton, United Kingdom

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

Phase 2

Completed

Conditions: Schizophrenia

Interventions: Drug: ASP4345
Drug: placebo
Drug: risperidone
Drug: quetiapine
Drug: olanzapine
Drug: ziprasidone
Drug: aripiprazole
Drug: brexpiprazole
Drug: paliperidone
Drug: lurasidone

First Posted Date: 2018-06-15

Last Posted Date: 2024-11-11

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 233

Registration Number: NCT03557931

Locations: 🇺🇸
CNS Research Science, Inc., Jamaica, New York, United States
🇺🇸
Synergy East, Lemon Grove, California, United States
🇺🇸
Pacific Research Partners, LLC, Oakland, California, United States

and more 22 locations

A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia

Phase 3

Completed

Conditions: Schizophrenia

Interventions: Drug: Lurasidone HCL 160 mg
Drug: Quetiapine XR 600 mg

First Posted Date: 2018-03-14

Last Posted Date: 2023-02-08

Lead Sponsor: Bukwang Pharmaceutical

Target Recruit Count: 210

Registration Number: NCT03465787

Locations: 🇰🇷
Borame Medical Center, Seoul, Seoul, Dongjak-gu, Korea, Republic of

Bariatric Surgery and Pharmacokinetics of Quetiapine

Recruiting

Conditions: Obesity, Morbid

First Posted Date: 2018-02-28

Last Posted Date: 2023-03-27

Lead Sponsor: Norwegian University of Science and Technology

Target Recruit Count: 12

Registration Number: NCT03449472

Locations: 🇳🇴
St. Olavs University Hospital, Trondheim, Norway

A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder

Completed

Conditions: Bipolar Disorder
Depression

Interventions: Drug: Quetiapine

First Posted Date: 2018-01-19

Last Posted Date: 2024-10-16

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 369

Registration Number: NCT03403790

Locations: 🇯🇵
Site JP00005, Akita, Japan
🇯🇵
Site JP00038, Ehime, Japan
🇯🇵
Site JP00007, Fukushima, Japan

and more 44 locations

A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy

Phase 2

Completed

Conditions: Depressive Disorder, Major

Interventions: Drug: Quetiapine XR
Drug: JNJ-42847922
Drug: Placebo Matching to JNJ-42847922
Drug: Placebo Matching to Quetiapine XR
Drug: Selective Serotonin Reuptake Inhibitor (SSRI)
Drug: Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

First Posted Date: 2017-10-25

Last Posted Date: 2025-04-29

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 107

Registration Number: NCT03321526

Locations: 🇺🇸
NoesisPharma Research, Phoenix, Arizona, United States
🇺🇸
Clinical Research Consortium Arizona, Tempe, Arizona, United States
🇺🇸
Woodland Research Northwest, Rogers, Arkansas, United States

and more 47 locations