Clinical Trials

Quetiapine fumarate has been evaluated in numerous clinical trials spanning early to late phases for psychiatric conditions—including bipolar disorder, acute and relapse schizophrenia, and first-episode psychosis—along with metabolic syndrome X and functional bowel disorders. Sponsored by pharmaceutical companies such as AstraZeneca alongside academic centers like Peking University, these studies encompass completed, recruiting, terminated, and withdrawn statuses. Key protocols include a clinical trial comparing quetiapine monotherapy to lithium as well as evaluations assessing dosing safety and patient outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07152184 NOT_YET_RECRUITING
Patient With Schizophrenia Spectrum Disorder; NLM Classification WM 203, Psychology:Schizophrenic Psychology; Schizophrenia Spectrum and Other Psychotic Disorders
University Hospital, Strasbourg, France
 2026-10-01 PHASE2
NCT06433635 ACTIVE_NOT_RECRUITING
Bipolar I Disorder; Depression
Massachusetts General Hospital
 2024-10-01 PHASE4
NCT05085808 WITHDRAWN
Delirium; Morality; Quality of Life; Psych; Treatment Side Effects
University of Southern California
 2028-03-01 PHASE4
NCT07654348 NOT_YET_RECRUITING
Bipolar Disorder II
First Affiliated Hospital of Zhejiang University
 2026-07-01 PHASE2
NCT06062953 RECRUITING
Psychiatric Disorders; Insomnia
Lone Baandrup
 2023-09-18 PHASE2; PHASE3
NCT07760168 NOT_YET_RECRUITING
Treatment Resistant Depression (TRD)
All India Institute of Medical Sciences, Bhubaneswar
 2026-08-30 PHASE3
NCT05973786 RECRUITING
Bipolar Depression
Dr. Inge Winter
 2025-02-11 PHASE3
NCT05603104 RECRUITING
Schizophrenia and Related Disorders; Major Depressive Disorder; Bipolar Depression
Dr. Inge Winter
 2025-04-27 PHASE3
NCT06333990 RECRUITING
Mild Traumatic Brain Injury
Foundation for Advancing Veterans' Health Research
 2024-07-09 PHASE3
NCT04373317 RECRUITING
Parkinson's Disease Psychosis
VA Office of Research and Development
 2022-10-24 PHASE4
NCT05480150 RECRUITING
Major Depressive Disorder; Bipolar Disorder, Mixed; Affective; Disorder, Organic
First Affiliated Hospital of Zhejiang University
 2021-11-01
NCT05590637 RECRUITING
Parkinson's Disease Psychosis; Dementia With Lewy Bodies
The University of Texas Health Science Center at San Antonio
 2022-04-22 PHASE4
NCT04728581 NOT_YET_RECRUITING
Osteo Arthritis Knee; Insomnia
St. Anna Ziekenhuis, Geldrop, Netherlands
 2024-01-01
NCT06581302 RECRUITING
Psychotic Disorders
Shanghai Jiao Tong University School of Medicine
 2024-09-01
NCT06546358 UNKNOWN
Postpartum Depression
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2024-09 EARLY_PHASE1
NCT04950868 ACTIVE_NOT_RECRUITING
Postpartum Depression
Verinder Sharma
 2022-03-18 PHASE1
NCT04936126 UNKNOWN
Treatment Resistant Depression
All India Institute of Medical Sciences, Bhubaneswar
 2021-08-07 PHASE4
NCT05240261 UNKNOWN
Chronic Kidney Diseases
Assiut University
 2022-05-01 PHASE1
NCT05542264 COMPLETED
Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2022-11-15 PHASE1
NCT04521478 COMPLETED
Depressive Disorder, Major
Boehringer Ingelheim
 2020-11-20 PHASE2
NCT04513912 COMPLETED
Depressive Disorder, Major
Janssen Research & Development, LLC
 2020-09-15 PHASE3
NCT05402111 COMPLETED
Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2022-06-13 PHASE1
NCT05690698 COMPLETED
Hyperactive Delirium
Alexandria University
 2023-04-09 PHASE3
NCT05303935 COMPLETED
Sleep Apnea, Obstructive
Flinders University
 2022-05-25 PHASE2
NCT05793632 COMPLETED
Delirium
Ain Shams University
 2023-03-01 PHASE2
NCT05801289 UNKNOWN
Delirium
Ain Shams University
 2022-12-04
NCT04513314 WITHDRAWN
Covid19; Hyperactive Delirium; Pneumonia, Viral
University of Miami
 2023-03-28 PHASE4
NCT04446234 UNKNOWN
Schizophrenia
Shanghai Mental Health Center
 2021-05 PHASE4
NCT04115319 COMPLETED
Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2019-11-21 PHASE3
NCT04209166 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
 2019-08-12
NCT03465787 COMPLETED
Schizophrenia
Bukwang Pharmaceutical
 2018-04-09 PHASE3
NCT04280965 COMPLETED
Post Traumatic Stress Disorder
The University of Texas Health Science Center at San Antonio
 2019-02-01 EARLY_PHASE1
NCT04338321 COMPLETED
Depressive Disorder, Major
Janssen-Cilag International NV
 2020-08-21 PHASE3
NCT05098353 UNKNOWN
Bipolar Affective Disorder
Federal Stare Budgetary Scientific Institution, Mental Health Research Center
 2021-04-10
NCT05235230 COMPLETED
Bioequivalence
Future University in Egypt
 2021-05-19 PHASE1
NCT06200584 COMPLETED
Antipsychotics and Neuroleptics Toxicity
Dr Rabia Arshad
 2021-01-01
NCT04310579 COMPLETED
Hypercapnia; Ventilatory Depression
Food and Drug Administration (FDA)
 2020-06-15 PHASE1
NCT02845453 COMPLETED
Substance Use Disorders; Bipolar Disorder; Mood Disorders
Boston Medical Center
 2017-01-20 PHASE4
NCT03004521 UNKNOWN
Depressive Disorder, Treatment-Resistant
King's College London
 2016-11 PHASE4
NCT04164758 TERMINATED
Parkinson's Disease
ACADIA Pharmaceuticals Inc.
 2019-10-23 PHASE2
NCT03739476 TERMINATED
Postoperative Delirium
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
 2019-02-13 PHASE3
NCT02630888 UNKNOWN
Bipolar Disorder
University of Sao Paulo
 2014-08 PHASE2
NCT03572257 WITHDRAWN
Delirium
Medical College of Wisconsin
 2019-04-15 PHASE2; PHASE3
NCT02431702 COMPLETED
Schizophrenia; Psychotic Disorders
Janssen Scientific Affairs, LLC
 2015-07-08 PHASE3
NCT03872596 COMPLETED
Bipolar Disorder; Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2019-03-27 PHASE1
NCT03557931 COMPLETED
Schizophrenia
Astellas Pharma Global Development, Inc.
 2018-07-13 PHASE2
NCT02087631 COMPLETED
Multiple Sclerosis
University of Calgary
 2014-12 PHASE1; PHASE2
NCT03321526 COMPLETED
Depressive Disorder, Major
Janssen Research & Development, LLC
 2017-12-12 PHASE2
NCT02562287 UNKNOWN
Bipolar Disorder
Hospital de Clinicas de Porto Alegre
 2015-10 PHASE4
NCT03568500 COMPLETED
Schizophrenia; Schizoaffective Disorder; First Episode Psychosis
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2018-05-21 PHASE4
NCT02720198 COMPLETED
Major Depressive Disorder
Duke University
 2017-01-23 PHASE3
NCT02901587 COMPLETED
Schizophrenia; Schizoaffective Disorder
H. Lundbeck A/S
 2016-09 PHASE1
NCT01858948 COMPLETED
Bipolar Youth Treated With Second-generation Antipsychotics
University of Cincinnati
 2013-07 PHASE3
NCT02282085 UNKNOWN
Schizophrenia
Matt Byerly
 2014-12 PHASE4
NCT01938859 UNKNOWN
Bipolar Disorder
Shanghai Mental Health Center
 2012-06 PHASE4
NCT03317236 COMPLETED
Healthy
Laboratorio Elea Phoenix S.A.
 2017-03-13 PHASE4
NCT02051387 COMPLETED
Schizophrenia
Central Institute of Mental Health, Mannheim
 2013-01 PHASE1
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02451306 UNKNOWN
Depression; Bipolar Disorder
RWTH Aachen University
 2015-06
NCT01697709 COMPLETED
Cannabis Dependence
New York State Psychiatric Institute
 2012-10-01 PHASE2
NCT03019887 COMPLETED
Schizophrenia Relapse
Juntendo University
 2011-04
NCT02650102 UNKNOWN
Schizophrenia
Shanxi Medical University
 2013-01 PHASE1; PHASE2
NCT02056171 TERMINATED
Delirium
Weill Medical College of Cornell University
 2015-03 PHASE1; PHASE2
NCT01588457 COMPLETED
Bipolar I Disorder; Bipolar II Disorder
The University of Texas Health Science Center at San Antonio
 2011-06 PHASE4
NCT02297763 UNKNOWN
Delirium
Seoul National University Hospital
 2015-03 PHASE3
NCT01811459 COMPLETED
Delirium
Centre hospitalier de l'Université de Montréal (CHUM)
 2013-02 PHASE3
NCT02131545 COMPLETED
Dementia; Delirium
Mayo Clinic
 2014-06 PHASE1
NCT02307396 COMPLETED
Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders
Technical University of Munich
 2015-02-01 PHASE4
NCT00893581 COMPLETED
Mania; Bipolar Disorder
University of Cincinnati
 2009-03
NCT02462473 TERMINATED
Schizophrenia; Schizoaffective Disorder
Janssen Research & Development, LLC
 2015-05 PHASE2
NCT01893229 UNKNOWN
Bipolar Disorder
Guiyun Xu
 2013-09 PHASE4
NCT01133821 COMPLETED
Bipolar Disorder; Depression
Holly Swartz
 2010-08 PHASE4
NCT01662297 TERMINATED
Insomnia; Mental Health Disorder; Substance Use Disorder
VA Connecticut Healthcare System
 2012-07 PHASE4
NCT01119014 COMPLETED
Psychosis
Anne Katrine Pagsberg
 2010-05 PHASE4
NCT01526148 TERMINATED
Bipolar Disorder
University Hospitals Cleveland Medical Center
 2012-01 PHASE4
NCT01810380 COMPLETED
Schizophrenia
H. Lundbeck A/S
 2013-03 PHASE3
NCT02137616 UNKNOWN
Psychotic Disorders
Central South University
 2012-06
NCT02040883 UNKNOWN
Schizophrenia
Qingyun Yin
 2014-02 PHASE4
NCT02087579 COMPLETED
Psychotic Disorders; Schizophrenia; Bipolar Disorder; Depressive Disorder
Janssen Research & Development, LLC
 2014-02 PHASE1
NCT00297947 COMPLETED
Schizophrenia; Schizoaffective Disorder
Manhattan Psychiatric Center
 2004-12 PHASE2; PHASE3
NCT01213121 UNKNOWN
Bipolar Depression
Seoul National University Bundang Hospital
 2010-09 PHASE4
NCT02192723 COMPLETED
Schizophrenia
Beijing HuiLongGuan Hospital
 2012-06
NCT02612948 COMPLETED
Psychomotor Agitation
University of Tennessee Graduate School of Medicine
 2013-11 PHASE4
NCT01871701 COMPLETED
Healthy
Seoul National University Hospital
 2012-11 PHASE1
NCT01844700 TERMINATED
High Risk MC4R Genotype; Low Risk MC4R Genotype; One Week or Less Antipsychotic Lifetime Exposure
Northwell Health
 2013-07 PHASE4
NCT00253266 COMPLETED
Depression
Max-Planck-Institute of Psychiatry
 2008-04 PHASE4
NCT00806234 COMPLETED
Psychotic Disorders
Johns Hopkins University
 2009-01 PHASE4
NCT01189318 WITHDRAWN
Major Depressive Disorder
Ewha Womans University
 2012-03 PHASE2
NCT02526030 COMPLETED
Schizophrenia; Psychotic Disorders
Fundación Marques de Valdecilla
 2008-10 PHASE4
NCT01458964 COMPLETED
Fibromyalgia
East Tennessee State University
 2008-01 PHASE4
NCT01157351 COMPLETED
Schizophrenia
Janssen Scientific Affairs, LLC
 2010-05 PHASE4
NCT00817323 WITHDRAWN
Bipolar Depression
University of British Columbia
 2009-01 PHASE3
NCT01725282 COMPLETED
Major Depressive Disorder
Astellas Pharma Inc
 2011-12-14 PHASE2
NCT01164059 COMPLETED
Schizophrenia
University of Bremen
 2010-02 PHASE4
NCT00773162 COMPLETED
Social Anxiety Disorder
START Clinic for Mood and Anxiety Disorders
 2008-10 PHASE3
NCT01971203 COMPLETED
Major Depressive Disorder; Generalized Anxiety Disorder
Icahn School of Medicine at Mount Sinai
 2009-09
NCT01710163 UNKNOWN
Bipolar I Disorder
University of Sao Paulo
 2012-06 PHASE4
NCT00688818 COMPLETED
Major Depressive Disorder; Dysthymic Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Post-traumatic Stress Disorder
Centre for Addiction and Mental Health
 2008-06
NCT01331304 COMPLETED
Bipolar Disorder
Massachusetts General Hospital
 2010-09 PHASE4
NCT00880919 COMPLETED
Borderline Personality Disorder
University of Minnesota
 2008-06 PHASE3
NCT00674765 COMPLETED
Alcoholism
University of Pennsylvania
 2008-01 PHASE2
NCT00893841 COMPLETED
Bipolar Depression
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
 2009-02 PHASE2
NCT01363310 TERMINATED
Depression With Prominent Agitation
Physicians Research And Education Network
 2010-10 PHASE3
NCT00955474 TERMINATED
Major Depressive Disorder With Psychotic Features
Massachusetts General Hospital
 2008-09 PHASE4
NCT01357967 UNKNOWN
Major Depressive Disorder
Inje University
 2011-05 PHASE4
NCT01256177 COMPLETED
Bipolar Depression
AstraZeneca
 2010-12 PHASE3
NCT01254721 TERMINATED
Acute Bipolar Mania
AstraZeneca
 2010-12 PHASE4
NCT01165541 COMPLETED
Alcohol Dependence
Dartmouth-Hitchcock Medical Center
 2010-09 PHASE2
NCT01129674 TERMINATED
Schizophrenia
Eli Lilly and Company
 2010-06 PHASE2; PHASE3
NCT01193166 WITHDRAWN
Schizophrenia
Ortho-McNeil Janssen Scientific Affairs, LLC
 2010-08 PHASE4
NCT01200901 COMPLETED
Depression; Healthy
University of Cincinnati
 2008-09 PHASE4
NCT01153490 COMPLETED
Cannabis Dependence
Northwell Health
 2010-10-22 PHASE4
NCT00751504 COMPLETED
Psychotic Depression
Ruhr University of Bochum
 2008-09 PHASE3
NCT02132286 COMPLETED
Major Depressive Disorder
University of Calgary
 2008-12 PHASE4
NCT00746421 TERMINATED
Bipolar Disorder; Cognitive Impairment
Emory University
 2010-01 PHASE4
NCT01607762 COMPLETED
Healthy
Janssen Research & Development, LLC
 2012-02 PHASE1
NCT01672554 UNKNOWN
Schizophrenia; Anxiety
Corporation de Recherche en Neuropsycho Pharmacologie de Quebec
 2008-12 PHASE3
NCT02142556 COMPLETED
Schizophrenia
Tri-Service General Hospital (TSGH)
 2008-11 PHASE3
NCT00982345 COMPLETED
Major Depression
Indiana University
 2009-03 PHASE4
NCT01197846 COMPLETED
Bipolar Disorder
Centro de Investigación Biomédica en Red de Salud Mental
 2010-09 PHASE3
NCT00953108 COMPLETED
Major Depression
Ludwig-Maximilians - University of Munich
 2009-09 PHASE3
NCT00617396 COMPLETED
Functional Bowel Disorders
University of North Carolina, Chapel Hill
 2008-02
NCT00393978 COMPLETED
Bipolar Disorder; Cannabis-Related Disorder
University of Cincinnati
 2006-11 PHASE4
NCT00606541 TERMINATED
Social Anxiety Disorder
Duke University
 2008-01 EARLY_PHASE1
NCT00619892 COMPLETED
Panic Disorder
Indiana University
 2008-02 PHASE4
NCT01400165 UNKNOWN
Healthy
University of Ottawa
 2011-07 PHASE1
NCT01603173 COMPLETED
Fasting State
IPCA Laboratories Ltd.
 2011-04 PHASE1
NCT01603186 COMPLETED
Fed
IPCA Laboratories Ltd.
 2011-04 PHASE1
NCT00983320 COMPLETED
Fibromyalgia
Université de Sherbrooke
 2008-04 PHASE4
NCT00951483 COMPLETED
Depression; Anxiety
Loyola University
 2009-07 PHASE4
NCT00868374 TERMINATED
Major Depressive Disorder; Generalized Anxiety Disorder
Keming Gao
 2008-06 PHASE3
NCT01250847 UNKNOWN
Abnormal Mental State; Schizophrenia
Severance Hospital
 2010-11 PHASE4
NCT01244711 TERMINATED
Major Depression; Generalized Anxiety Disorder
Weill Medical College of Cornell University
 2008-09 PHASE4
NCT01939093 COMPLETED
Methamphetamine-induced Psychosis
Chulalongkorn University
 2010-03 PHASE4
NCT00879307 UNKNOWN
BIPOLAR DISORDER
Hospital de Clinicas de Porto Alegre
 2009-03 PHASE3
NCT01587066 WITHDRAWN
Bipolar Depression
Bo-Hyun Yoon
 2010-08 PHASE4
NCT00668265 TERMINATED
Generalized Anxiety Disorder; Comorbid Opiate Dependence in Remission; Status Post Methadone-Maintenance Treatment
Beth Israel Medical Center
 2008-01 PHASE4
NCT01213836 COMPLETED
Schizophrenia
AstraZeneca
 2010-11 PHASE4
NCT00186043 COMPLETED
Bipolar II Disorder
Stanford University
 2008-08 PHASE4
NCT00457197 COMPLETED
Bipolar Disorder; Alcohol Dependence
University of Texas Southwestern Medical Center
 2007-03 PHASE4
NCT00789698 COMPLETED
Chronic Schizophrenia
Sumitomo Pharma America, Inc.
 2008-12 PHASE3
NCT00675896 COMPLETED
Major Depression
Dr Alexander McIntyre Inc.
 2007-04 PHASE4
NCT00954603 TERMINATED
Delirium
Chiang Mai University
 2009-06 PHASE3
NCT00782405 COMPLETED
Sleep
Technical University of Munich
 2008-10 PHASE3
NCT00509067 COMPLETED
Schizophrenia
Georgetown University
 2007-11 PHASE2
NCT00872716 COMPLETED
Specific Phobia
University Hospital Muenster
 2009-04 PHASE2
NCT00883493 COMPLETED
Acute Bipolar Depression
AstraZeneca
 2009-04 PHASE3
NCT01128114 TERMINATED
Acute Bipolar Mania
AstraZeneca
 2010-06 PHASE4
NCT00671853 COMPLETED
Bipolar Disorder; Anxiety; Anxiety Disorders; Substance Use Disorders
University Hospitals Cleveland Medical Center
 2008-04 PHASE3
NCT00857584 COMPLETED
Bipolar Disorder; Bipolar Depression
AstraZeneca
 2009-05 PHASE3
NCT02305823 COMPLETED
Schizophrenia; Psychotic Disorders
Fundación Marques de Valdecilla
 2005-10 PHASE4
NCT00330863 COMPLETED
Schizophrenia; Schizoaffective Disorder
Northwell Health
 2006-05 PHASE4
NCT02534363 COMPLETED
Schizophrenia; Psychotic Disorders
Fundación Marques de Valdecilla
 2005-10 PHASE4
NCT01195363 COMPLETED
Bipolar Disorder
The University of Texas Health Science Center at San Antonio
 2007-04 PHASE4
NCT00554658 COMPLETED
Schizophrenia
University of Regensburg
 2008-03 PHASE4
NCT00892463 COMPLETED
Depressive Disorder, Major
Sunnybrook Health Sciences Centre
 2009-05 PHASE4
NCT00579280 COMPLETED
Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder
University of South Florida
 2007-07 PHASE4
NCT00811473 COMPLETED
Bipolar Depression
AstraZeneca
 2009-01 PHASE3
NCT00183443 COMPLETED
Bipolar Disorder; Schizophrenia
Palo Alto Veterans Institute for Research
 2005-02 PHASE3
NCT00931723 COMPLETED
Acute Mania
AstraZeneca
 2009-06 PHASE4
NCT00837343 UNKNOWN
Bipolar Disorder
Guangzhou Mental Hospital
 2008-12 PHASE4
NCT00986167 UNKNOWN
Schizophrenia; Psychosis
Bayside Health
 2009-10 PHASE4
NCT00511277 COMPLETED
Schizophrenia
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
 2007-08 PHASE4
NCT00517387 COMPLETED
Unipolar Depression
University of British Columbia
 2007-09 PHASE3
NCT01071135 TERMINATED
Schizophrenia
Hannover Medical School
 2009-09 PHASE3
NCT00954681 COMPLETED
Cannabis Dependence
New York State Psychiatric Institute
 2009-08 PHASE2
NCT00631748 COMPLETED
Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Drug Abuse; Substance Abuse
Seattle Institute for Biomedical and Clinical Research
 2008-02
NCT01527448 COMPLETED
Postpartum Depression
BC Women's Hospital & Health Centre
 2008-04
NCT00790192 COMPLETED
Schizophrenia
Sumitomo Pharma America, Inc.
 2008-10 PHASE3
NCT00912535 COMPLETED
Primary Anxiety Disorders; Mood Disorders With Comorbid Anxiety Symptoms
Chang Gung Memorial Hospital
 2009-05 PHASE4
NCT00640601 COMPLETED
Schizophrenia
AstraZeneca
 2008-03 PHASE3
NCT00882518 COMPLETED
Schizophrenia
AstraZeneca
 2009-04 PHASE3
NCT00550394 COMPLETED
Bipolar Disorder; Alcohol Abuse
University of Cincinnati
 2008-04 PHASE4
NCT01566487 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2010-06 PHASE1
NCT00742638 UNKNOWN
Bipolar Disorder
Shanghai Jiao Tong University School of Medicine
 2008-03
NCT00817648 COMPLETED
Schizophrenia
Shanghai Mental Health Center
 2008-12 PHASE4
NCT00518973 COMPLETED
Anorexia Nervosa
University of California, San Diego
 2006-07
NCT00838032 UNKNOWN
Acute Schizophrenia
Sichuan University
 2008-08 PHASE4
NCT00852631 TERMINATED
Schizophrenia
AstraZeneca
 2009-02 PHASE3
NCT00919607 COMPLETED
Schizophrenia
AstraZeneca
 2009-06 PHASE1
NCT00954122 COMPLETED
Schizophrenia
AstraZeneca
 2009-09 PHASE4
NCT00857818 TERMINATED
Schizophrenia; Schizoaffective Disorder; Bipolar I Disorder; Metabolic Syndrome
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2009-04 PHASE3
NCT00766350 COMPLETED
Fibromyalgia
Universidad de Granada
 2008-11 PHASE4
NCT00466609 COMPLETED
Obsessive Compulsive Disorder
University of Sao Paulo
 2007-05 PHASE4
NCT01552837 COMPLETED
Bipolar Disorder
RWTH Aachen University
 2007-12
NCT00640562 COMPLETED
Schizophrenia; Depression
AstraZeneca
 2008-02 PHASE3
NCT00654706 COMPLETED
Schizophrenia; Cognition
H. Lundbeck A/S
 2008-03 PHASE3
NCT00932529 COMPLETED
Psychotic Disorders
University of Bergen
 2003-02 PHASE4
NCT00232570 UNKNOWN
Alzheimer's Disease; Insomnia
University of Vermont
 2005-11
NCT00434876 COMPLETED
Alcoholism; Sleep Initiation and Maintenance Disorders
Subhajit Chakravorty
 2007-08 PHASE3
NCT00423878 COMPLETED
Schizophrenia; Schizoaffective Disorder
National Institute of Mental Health (NIMH)
 2007-01 PHASE4
NCT00600756 COMPLETED
Schizophrenic Disorders
AstraZeneca
 2008-01 PHASE3
NCT00439634 TERMINATED
Schizophrenia
Sanofi
 2007-02 PHASE2
NCT00567866 TERMINATED
Methamphetamine Dependence
University of Arkansas
 2008-01 EARLY_PHASE1
NCT00658645 TERMINATED
Schizophrenia
H. Lundbeck A/S
 2008-03 PHASE3
NCT00704509 TERMINATED
Schizophrenia
H. Lundbeck A/S
 2008-06 PHASE3
NCT00926393 COMPLETED
Bipolar Depression
AstraZeneca
 2009-06 PHASE4
NCT01047215 UNKNOWN
Schizophrenia; Bipolar
Taichung Veterans General Hospital
 2009-08 PHASE4
NCT00498628 COMPLETED
Alcoholism; Alcohol Abuse
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2007-12 PHASE2
NCT00561587 COMPLETED
Alcohol Relapse Prevention; Alcoholism; Alcohol Drinking; Alcohol Consumption; Alcohol Abuse
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
 2007-11 PHASE2
NCT00521365 COMPLETED
Bipolar Disorder; Bipolar Affective Psychosis; Mania; Manic Disorder; Manic State
AstraZeneca
 2008-05 PHASE4
NCT00789854 COMPLETED
Major Depressive Disorder; Treatment Resistant Depression
AstraZeneca
 2008-11 PHASE3
NCT00672490 COMPLETED
Acute Mania in Bipolar Disorder
AstraZeneca
 2008-04 PHASE4
NCT00642369 COMPLETED
Schizophrenia
Guang Dong Provincial Mental Health Institute
 2008-03
NCT00779506 COMPLETED
Schizophrenia
AstraZeneca
 2008-11 PHASE4
NCT00584688 TERMINATED
Anorexia Nervosa
University of South Florida
 2007-02 PHASE2
NCT00771134 TERMINATED
Bipolar Disorder
H. Lundbeck A/S
 2008-12 PHASE2
NCT00723970 COMPLETED
Major Depressive Disorder; Insomnia; Hot Flashes
McMaster University
 2007-06 PHASE4
NCT00181883 COMPLETED
Bipolar Disorder; Mania
Massachusetts General Hospital
 2005-02 PHASE4
NCT00797927 COMPLETED
Schizophrenia
National Taiwan University Hospital
 2007-01 PHASE4
NCT00044655 COMPLETED
Schizophrenia
Icahn School of Medicine at Mount Sinai
 2001-07 PHASE4
NCT00508157 TERMINATED
Metabolic Syndrome; Schizophrenia
Bristol-Myers Squibb
 2007-11 PHASE4
NCT00743366 COMPLETED
Marijuana Smoking
New York State Psychiatric Institute
 2008-08 PHASE2
NCT00622245 TERMINATED
Depression in Patients With Bipolar Disorder
H. Lundbeck A/S
 2008-01 PHASE2
NCT00397020 COMPLETED
Bipolar Disorder
University of California, San Diego
 2006-12 PHASE4
NCT00292370 COMPLETED
Combat Disorders; Stress Disorders, Post-Traumatic
VA Office of Research and Development
 2006-01 PHASE4
NCT01081418 COMPLETED
Schizophrenia
Universitätsklinikum Hamburg-Eppendorf
 2005-04 PHASE4
NCT00837343 Unknown status
Bipolar Disorder
Guangzhou Mental Hospital|First Affiliated Hospital of Jinan University|Second Affiliated Hospital of Guangzhou Medical University|Guangzhou mental Hospital Attached to Guangzhou Civil Affairs Bureau
 2008-12 Phase 4
NCT00660595 TERMINATED
Schizophrenic Disorders
AstraZeneca
 2008-09 PHASE3
NCT00515723 COMPLETED
Schizophrenia; Schizoaffective Disorder; Type 2 Diabetes Mellitus; Hyperglycemia
Washington University School of Medicine
 2001-09
NCT00406315 COMPLETED
Schizophrenia; Schizoaffective Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-11 PHASE4
NCT00681629 TERMINATED
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
AstraZeneca
 2008-07 PHASE4
NCT00206102 COMPLETED
Schizophrenia; Schizoaffective Disorder
AstraZeneca
 2003-09 PHASE4
NCT00681668 TERMINATED
Postpartum Depressive Disorder
AstraZeneca
 2007-08 PHASE2
NCT00498004 TERMINATED
Schizophrenia
Inje University
 2007-08 PHASE4
NCT00207064 COMPLETED
Schizophrenia
Birte Glenthoj
 2004-04
NCT00534599 COMPLETED
Anxiety; Anxiety Disorders; Anxiety Neuroses; Anxiety States
AstraZeneca
 2007-08 PHASE3
NCT00838032 Unknown status
Acute Schizophrenia
Sichuan University
 2008-08 Phase 4
NCT00702676 COMPLETED
Healthy Volunteers
AstraZeneca
 2008-07 PHASE1
NCT00457366 COMPLETED
Agitation
University of Southern California
 2006-05 PHASE4
NCT01224067 COMPLETED
Social Anxiety Disorder
Cambridge Health Alliance
 2006-03 PHASE4
NCT00370500 COMPLETED
Schizophrenia
University of Erlangen-Nürnberg Medical School
 2007-04 PHASE4
NCT00389064 COMPLETED
Anxiety Disorders
AstraZeneca
 2006-09 PHASE3
NCT00462618 COMPLETED
Insomnia
Michael E. DeBakey VA Medical Center
 2007-04 PHASE2; PHASE3
NCT00347425 COMPLETED
Schizophrenia and Schizoaffective Disorder
Solvay Pharmaceuticals
 2006-12 PHASE3
NCT00396214 TERMINATED
Schizophrenia
Solvay Pharmaceuticals
 2007-04 PHASE3
NCT00654576 COMPLETED
Schizophrenia
Central South University
 2005-02 PHASE4
NCT00564564 COMPLETED
Obsessive Compulsive Disorder
University of Sao Paulo
 2006-01 PHASE4
NCT00232414 COMPLETED
Bipolar I Disorder
University of Cincinnati
 2005-10 PHASE3
NCT00277667 COMPLETED
Bipolar Disorder
Lindner Center of HOPE
 2004-02 PHASE3
NCT00227305 COMPLETED
Schizophrenia; Bipolar I Disorder
AstraZeneca
 2004-08 PHASE3
NCT00255515 COMPLETED
Schizophrenia
AstraZeneca
 2005-09 PHASE4
NCT00223210 COMPLETED
Bipolar Disorder; Cocaine Dependence
University of Texas Southwestern Medical Center
 2005-11 PHASE4
NCT00252226 COMPLETED
Bipolar Disorder
Mood Disorders Center of Ottawa
 2004-06 PHASE3
NCT00388973 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-09 PHASE3
NCT00733668 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-03 PHASE2
NCT01570959 COMPLETED
Bipolar I Disorder
Roxane Laboratories
 2007-04
NCT00216476 COMPLETED
Schizophrenia; Psychotic Disorders
Janssen-Cilag International NV
 2004-10 PHASE3
NCT00325689 COMPLETED
Schizophrenia; Schizoaffective Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2006-07 PHASE4
NCT00428350 COMPLETED
Schizophrenia
AstraZeneca
 2006-12 PHASE4
NCT00122070 COMPLETED
Borderline Personality Disorder
University of Medicine and Dentistry of New Jersey
 2005-05 PHASE3
NCT00407199 COMPLETED
Social Phobia
University of Minnesota
 2006-12 PHASE4
NCT00306540 COMPLETED
Post-Traumatic Stress Disorder
AstraZeneca
 2004-12 PHASE3
NCT00309699 COMPLETED
Bipolar Disorder; Mood Disorders
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2006-04 PHASE3
NCT00486798 TERMINATED
Psychotic Disorders; Schizophrenia; Bipolar Disorder
AstraZeneca
 2007-05 PHASE3
NCT01570894 COMPLETED
Bipolar I Disorder
Roxane Laboratories
 2007-07
NCT03207438 COMPLETED
Depressive Disorder, Major
University of Saskatchewan
 2006-04 PHASE4
NCT01570907 COMPLETED
Treatment for Bipolar I Disorder
Roxane Laboratories
 2007-06
NCT00631722 Completed
Schizophrenia
Peking University
 2007-05 Not Applicable
NCT00113295 COMPLETED
Anxiety Disorder
Massachusetts General Hospital
 2004-02 PHASE4
NCT00302770 TERMINATED
Social Anxiety Disorder
AstraZeneca
 2006-06 PHASE3
NCT00156715 COMPLETED
Schizophrenia; Schizoaffective Disorder; Psychotic Disorder; Substance Abuse; Alcohol Abuse
Dartmouth-Hitchcock Medical Center
 2004-03 PHASE4
NCT00048802 COMPLETED
Bipolar Disorder
Northwell Health
 2002-08 PHASE4
NCT00280501 COMPLETED
Regional Blood Flow; Ocular Physiology
Medical University of Vienna
 2005-08
NCT00139074 TERMINATED
Bipolar Disorder
AstraZeneca
 2005-07 PHASE4
NCT00221468 COMPLETED
Mood Disorders
University of Cincinnati
 2003-06 PHASE3
NCT00206128 COMPLETED
Schizophrenia
AstraZeneca
 2004-11 PHASE3
NCT00232336 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
Seattle Institute for Biomedical and Clinical Research
 2003-10 PHASE4
NCT00449397 COMPLETED
Psychosis
AstraZeneca
 2003-07 PHASE3
NCT00550147 COMPLETED
Attention Deficit Disorder With Hyperactivity
Indiana University
 2004-02 PHASE2
NCT00124059 COMPLETED
Alcoholism
University of Pennsylvania
 2003-03 PHASE3
NCT00448578 Completed
Mania|Bipolar Disorder
AstraZeneca
 2005-08 Phase 3
NCT00237913 COMPLETED
Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2004-07 PHASE3
NCT00043849 COMPLETED
Dementia; Parkinson Disease
National Institute on Aging (NIA)
 2002-07 PHASE4
NCT00034892 COMPLETED
Schizophrenia; Psychotic Disorders; Mental Health; Mental Disorders
AstraZeneca
 2002-03 PHASE3
NCT00161018 COMPLETED
Schizophrenia
University of Maryland, Baltimore
 2003-11 PHASE3
NCT00223249 COMPLETED
Bipolar Disorder; Alcohol Abuse/Dependence
University of Texas Southwestern Medical Center
 2002-11 PHASE4
NCT00255879 COMPLETED
Dyskinesia, Drug-Induced
University of California, San Diego
 1999-01 PHASE1
NCT00182013 COMPLETED
Bipolar Spectrum Disorder
Massachusetts General Hospital
 2001-06 PHASE4
NCT00621647 COMPLETED
Alzheimer's Disease; Vascular Dementia
AstraZeneca
 2002-09 PHASE3
NCT00060489 COMPLETED
Bipolar Disorder; Depression, Bipolar
AstraZeneca
 2002-09 PHASE3
NCT00237861 COMPLETED
Schizophrenia
Yale University
 PHASE4
NCT00034905 COMPLETED
Schizophrenia
AstraZeneca
 2001-07 PHASE4
NCT00159770 COMPLETED
Schizophrenia; Schizoaffective Disorder; Psychotic Disorders
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2001-11 PHASE3
NCT00254774 COMPLETED
Bipolar Disorder
AstraZeneca
 2002-01 PHASE3
NCT00206115 COMPLETED
Schizophrenic Disorder
AstraZeneca
 2004-11 PHASE3
NCT00085891 COMPLETED
Schizophrenia
AstraZeneca
 2004-06 PHASE3
NCT00329446 COMPLETED
Generalized Anxiety Disorder
AstraZeneca
 2006-04 PHASE3
NCT00326105 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-04 PHASE3
NCT00422123 COMPLETED
Affective Psychosis, Bipolar; Manic Disorder; Manic-Depressive Psychosis; Mania; Manic State; Psychoses, Manic-Depressive
AstraZeneca
 2007-01 PHASE3
NCT00334126 COMPLETED
Schizophrenia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2006-04 PHASE3
NCT00014001 COMPLETED
Schizophrenia
National Institute of Mental Health (NIMH)
 2000-12 PHASE4
NCT00334035 COMPLETED
Schizophrenia
The University of Hong Kong
 2003-08 PHASE4
NCT00215254 COMPLETED
Social Anxiety Disorder
Duke University
 2004-03 PHASE2; PHASE3
NCT00234377 COMPLETED
Schizophrenia
AstraZeneca
 2004-11 PHASE3
NCT00832221 COMPLETED
Depression
AstraZeneca
 2009-01 PHASE1
NCT00351169 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-05 PHASE3
NCT00326144 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-04 PHASE3
NCT00375557 WITHDRAWN
Alzheimer's Disease; Dementia; Behavioral Symptoms
University of Cincinnati
 2006-10 PHASE4
NCT00318539 COMPLETED
Obsessive Compulsive Disorder
AstraZeneca
 2003-12 PHASE2
NCT00231101 UNKNOWN
Smoking Behavior in Schizophrenia
Arthur P. Noyes Research Foundation
 2004-01
NCT00304473 COMPLETED
Schizophrenia
AstraZeneca
 2004-08 PHASE3
NCT00305422 COMPLETED
Schizophrenia
AstraZeneca
 2001-11 PHASE3
NCT00061802 COMPLETED
Schizophrenia; Schizoaffective Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2003-06 PHASE4
NCT00208819 COMPLETED
Senile Dementia, Alzheimer Type; Dementia, Alzheimer Type; Alzheimer Disease; Dementia
Emory University
 2003-09 PHASE4
NCT00314210 COMPLETED
Anxiety Disorders
AstraZeneca
 2006-03 PHASE3
NCT00182442 COMPLETED
Schizophrenia
Hamilton Health Sciences Corporation
 2003-10 PHASE4
NCT00081380 COMPLETED
Bipolar Disorder
AstraZeneca
 2004-03 PHASE3
NCT00119652 COMPLETED
Bipolar Disorder; Bipolar Depression; Depression
AstraZeneca
 2005-05 PHASE3
NCT00208143 COMPLETED
Schizophrenia; Schizoaffective Disorder; Substance Abuse; Substance Dependence
Creighton University
 2003-11 PHASE4
NCT00254813 COMPLETED
Psychotic Disorders
AstraZeneca
 2004-10 PHASE3
NCT00321490 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-04 PHASE3
NCT00422214 COMPLETED
Affective Psychosis, Bipolar; Depression, Bipolar; Manic-Depressive Psychosis; Psychoses, Manic-Depressive
AstraZeneca
 2006-12 PHASE3
NCT00222495 COMPLETED
Psychotic Disorders; Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorders
University of Minnesota
 2002-08
NCT00295412 COMPLETED
Schizophrenia; Substance Use Disorders
Université de Montréal
 PHASE4
NCT00090324 COMPLETED
Schizophrenia
AstraZeneca
 2004-09 PHASE3
NCT01634386 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
 PHASE1
NCT00097032 COMPLETED
Bipolar Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2004-10 PHASE3
NCT00206141 COMPLETED
Bipolar Disorder; Bipolar Depression; Depression
AstraZeneca
 2005-08 PHASE3
NCT00351910 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-05 PHASE3
NCT00090012 COMPLETED
Schizophrenia; Schizoaffective Disorder
Eli Lilly and Company
 2004-07 PHASE4
NCT00237393 COMPLETED
PTSD
Ralph H. Johnson VA Medical Center
 2003-08 PHASE4
NCT00322595 COMPLETED
Generalized Anxiety Disorder
AstraZeneca
 2006-05 PHASE3
NCT00090311 COMPLETED
Bipolar Disorder
AstraZeneca
 2004-07 PHASE3
NCT00018642 COMPLETED
Schizophrenia; Schizoaffective Disorder
US Department of Veterans Affairs
 1997-04
NCT00228462 COMPLETED
Schizophrenia
AstraZeneca
 2005-03 PHASE3
NCT00328978 COMPLETED
Schizophrenia; Schizoaffective Disorders
AstraZeneca
 2003-10 PHASE3
NCT00254748 COMPLETED
Borderline Personality Disorder
AstraZeneca
 2004-06 PHASE2
NCT00227123 COMPLETED
Bipolar Disorder; Cocaine Dependence; Methamphetamine Dependence
University of Texas Southwestern Medical Center
 2002-10
NCT00254735 COMPLETED
Obsessive Compulsive Disorder
AstraZeneca
 2002-04 PHASE3
NCT00314184 COMPLETED
Bipolar Disorder
AstraZeneca
 2005-03 PHASE3
NCT00320268 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-04 PHASE3
NCT00328822 COMPLETED
Primary Insomnia
Khon Kaen University
 2006-12
NCT00329264 COMPLETED
Generalized Anxiety Disorder
AstraZeneca
 2006-04 PHASE3
NCT00174603 TERMINATED
Major Depression With Psychotic Features
Rush University Medical Center
 2005-08 PHASE3
NCT00448578 COMPLETED
Mania; Bipolar Disorder
AstraZeneca
 2005-08 PHASE3
NCT00457899 TERMINATED
Schizophrenia; Schizoaffective Disorders; Psychotic Disorders
AstraZeneca
 2007-07 PHASE3
NCT01634373 COMPLETED
Schizophrenia
Torrent Pharmaceuticals Limited
 PHASE1
NCT00087750 UNKNOWN
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
 2003-10 PHASE1
NCT01634399 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
 PHASE1
NCT00018668 COMPLETED
Schizophrenia
US Department of Veterans Affairs
 2000-10 PHASE4
NCT00214578 COMPLETED
Schizophrenia
AstraZeneca
 2004-04 PHASE4
NCT00229645 COMPLETED
Major Depression With Comorbid Anxiety Symptoms
Dr Alexander McIntyre Inc.
 2003-11 PHASE4
NCT00791622 COMPLETED
Schizophrenia; Schizoaffective Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2006-01 PHASE1
NCT00107731 COMPLETED
Bipolar I Disorder
AstraZeneca
 2004-04 PHASE3
NCT00278941 COMPLETED
Major Depressive Disorder
AstraZeneca
 2005-12 PHASE3
NCT00083954 COMPLETED
Bipolar Disorder
AstraZeneca
 2004-06 PHASE3
NCT00114686 COMPLETED
Bipolar I Disorder; Alcohol Dependence
AstraZeneca
 2006-01 PHASE3
NCT00254787 COMPLETED
Schizophrenia
AstraZeneca
 2005-06 PHASE2
NCT00015548 COMPLETED
Alzheimer's Disease
National Institute of Mental Health (NIMH)
 2001-03

(data from https://clinicaltrials.gov, updated on 2026-05-26)

Check the Quetiapine (ICI-204636) fumarate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quetiapine fumarate acts as a multi-target antagonist binding to dopamine D2, serotonin 5-HT2A, histamine H1, and adrenergic receptors, thereby inhibiting downstream monoaminergic signal transduction pathways and modulating central neurotransmitter dynamics. This receptor blockade alters cellular firing and neurochemical balances to stabilize mood and suppress psychotic features, directly underwriting its clinical efficacy observed in trials for schizophrenia and bipolar disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.