Clinical Trials

Sertraline hydrochloride has been evaluated in numerous clinical trials spanning Phase 1 safety assessments through Phase 4 post-marketing studies to investigate its pharmacokinetics, physiological impacts, and therapeutic potential. Research predominantly focuses on major depressive disorder, anxiety disorders, post-traumatic stress disorder, bipolar disorder, and depressive symptoms secondary to acute coronary syndrome or obesity. Sponsored by academic centers such as Columbia University and the University of Pennsylvania alongside industry entities like Pfizer and Viatris, these studies feature recruitment statuses ranging from recruiting and active to completed and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00262470 ACTIVE_NOT_RECRUITING
Tachycardia; Chronic Orthostatic Intolerance
Satish R. Raj
1997-04 PHASE1; PHASE2
NCT06704594 RECRUITING
Premenstrual Dysphoric Disorder (PMDD)
Johns Hopkins University
2025-05-14 PHASE4
NCT07645157 RECRUITING
Major Depressive Disorder (MDD); Probiotic Intervention
First Affiliated Hospital of Chongqing Medical University
2026-10-01 PHASE2
NCT06408246 RECRUITING
Depression
Stanford University
2026-03-03 PHASE2
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
NCT07539805 RECRUITING
Major Depressive Disorder (MDD); Probiotic Intervention
First Affiliated Hospital of Chongqing Medical University
2026-06-11 PHASE2
NCT06384209 RECRUITING
Major Depressive Disorder; Severe Depressive Episode Without Psychotic Symptoms
University of Bern
2025-06-26
NCT07478796 RECRUITING
Depression - Major Depressive Disorder; Depressive Episodes
Poznan University of Medical Sciences
2025-04-03 PHASE4
NCT07318181 RECRUITING
Post Traumatic Stress Disorder; Post Traumatic Stress Disorder PTSD; Post-Traumatic Stress Disorder, PTSD
University of Luxembourg
2026-01-01
NCT06081348 RECRUITING
Neurodevelopmental Disorders; Autism; Autism Spectrum Disorder; Fragile X Syndrome; Tuberous Sclerosis; 22Q11 Deletion Syndrome; 22Q11 Deletion; ADHD; Tic Disorders; Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence; ADHD - Combined Type; ADHD Predominantly Inattentive Type; ADHD, Predominantly Hyperactive - Impulsive; Anxiety; Anxiety Disorders
Holland Bloorview Kids Rehabilitation Hospital
2024-09-16 PHASE2
NCT05892744 RECRUITING
Major Depressive Disorder; Chronic Major Depression, Recurrent
University of Texas at Austin
2023-09-30 PHASE4
NCT07139834 RECRUITING
Major Depressive Disorder (MDD)
Jeffrey Miller
2026-06-01 PHASE1
NCT05683223 RECRUITING
Social Anxiety Disorder
Boston University Charles River Campus
2023-05-26
NCT04539951 RECRUITING
Obsessive-Compulsive Disorder
Shanghai Mental Health Center
2020-09-22 PHASE2
NCT07011693 NOT_YET_RECRUITING
Major Depressive Disorder (MDD)
Xinyu Zhou
2025-06-20 PHASE4
NCT07574060 RECRUITING
Depression
Tanta University
2026-05-20 PHASE2; PHASE3
NCT05273996 ACTIVE_NOT_RECRUITING
Major Depressive Disorder; Neuroticism; Cognitive Change; Stress
David Steffens
2021-09-28 PHASE4
NCT07025590 RECRUITING
Cardiovascular Diseases (CVD); Depression Anxiety Disorder
Guangdong Provincial People's Hospital
2025-04-22
NCT05814640 RECRUITING
Depression; Sequestra
First Affiliated Hospital of Chongqing Medical University
2023-02-20 PHASE1; PHASE2
NCT06796946 NOT_YET_RECRUITING
Deprescription; Antidepressants
University of Huelva
2026-06 EARLY_PHASE1
NCT04637620 RECRUITING
Major Depressive Disorder
China Medical University Hospital
2017-06-01 PHASE2
NCT04221997 RECRUITING
Anxiety Disorders
University of Cincinnati
2019-11-01 PHASE4
NCT07192367 RECRUITING
Social Anxiety Disorder
Emine Kanmaz
2024-11-15 PHASE4
NCT06827431 NOT_YET_RECRUITING
Major Depressive Disorder (MDD)
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2025-02-14 PHASE3
NCT06965569 COMPLETED
Treatment Resistant Depression
Alar Pharmaceuticals Inc.
2025-04-21 PHASE1
NCT02890212 SUSPENDED
Major Depression
University of Sao Paulo General Hospital
2005-08
NCT05537584 COMPLETED
Major Depressive Disorder
Mclean Hospital
2022-09-30 PHASE4
NCT06840379 ACTIVE_NOT_RECRUITING
Inflamation; Hemodialysis; End Stage Renal Disease on Hemodialysis (Diagnosis)
Nishtar Medical University
2024-10-15
NCT04183205 TERMINATED
Posttraumatic Stress Disorder; Major Depressive Disorder
VA Office of Research and Development
2019-09-11 PHASE4
NCT06698666 RECRUITING
Major Depressive Disorder; MDD
Ain Shams University
2022-10-01 PHASE3
NCT06725771 COMPLETED
Generalised Anxiety Disorder
Lin Xiaoqian
2022-09-01
NCT06357104 COMPLETED
COVID-19 Vaccine Adverse Reaction
Pachankis, Yang I., M.D.
2024-02-26 PHASE4
NCT04963257 UNKNOWN
OCD
Second Affiliated Hospital, Zhejiang University, School of Medicine
2020-01-01 PHASE4
NCT05646693 UNKNOWN
Tinnitus, Subjective; Tinnitus, Bilateral; Antioxidant Therapy; Psychiatric Drugs; Oxidative Stress; Inflammatory Cytokines; SSRI
University of Guadalajara
2022-12-01 PHASE2
NCT06025474 UNKNOWN
Burning Mouth Syndrome
Federico II University
2023-01-01 PHASE3
NCT06124417 COMPLETED
Efficacy, Team; Adverse Reaction to Drug
First Affiliated Hospital of Chongqing Medical University
2022-01-10 PHASE4
NCT05189977 TERMINATED
Post-traumatic Stress Disorder (PTSD)
Otsuka Pharmaceutical Development & Commercialization, Inc.
2022-09-07 PHASE1
NCT04174170 COMPLETED
Post Traumatic Stress Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.
2019-10-30 PHASE3
NCT04124614 COMPLETED
Post Traumatic Stress Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.
2019-10-17 PHASE3
NCT04388202 WITHDRAWN
Major Depressive Disorder
Alto Neuroscience
2020-10-15 PHASE4
NCT05588102 COMPLETED
Geriatric Depression; Cognitive Impairment
Capital Medical University
2021-05-18
NCT05730062 Not yet recruiting
Opioid Induced Respiratory Depression|Depressive Disorder|Anxiety Disorders
Leiden University Medical Center
2023-03-15 Phase 1
NCT03779789 COMPLETED
Major Depressive Disorder
Azienda Ospedaliera Universitaria Integrata Verona
2019-02-01 PHASE4
NCT03279471 COMPLETED
Autism Spectrum Disorder; Anxiety
University of California, Davis
2017-10-01 PHASE2
NCT05950061 COMPLETED
Major Depressive Disorder
KRL Hospital, Islamabad
2022-06-01 PHASE3
NCT05341843 COMPLETED
Uremic Pruritis
Alexandria University
2022-05-01 PHASE2
NCT04977544 UNKNOWN
Phobia
Second Affiliated Hospital, Zhejiang University, School of Medicine
2019-09-01
NCT05189977 Terminated
Post-traumatic Stress Disorder (PTSD)
Otsuka Pharmaceutical Development & Commercialization Inc.|Iqvia Pty Ltd
2022-09-07 Phase 1
NCT02777372 COMPLETED
PMDD; Stress; Mood
Johns Hopkins University
2016-04-01 PHASE4
NCT04476030 COMPLETED
Depressive Disorder, Major
Biogen
2020-11-09 PHASE3
NCT02917122 TERMINATED
Parkinson Disease; Depression
National Cheng-Kung University Hospital
2015-08 PHASE1; PHASE2
NCT03852160 WITHDRAWN
Depressive Disorder, Treatment-Resistant
Janssen-Cilag International NV
2019-12-01 PHASE3
NCT03841474 UNKNOWN
Coronary Artery Disease; Depression; Cardiovascular Diseases
Klinički Bolnički Centar Zagreb
2021-03-01
NCT03434041 COMPLETED
Depressive Disorder, Treatment-Resistant
Janssen Research & Development, LLC
2018-05-25 PHASE3
NCT04430556 UNKNOWN
Major Depressive Disorder; Anxiety Disorders
Hospital Universitario Dr. Jose E. Gonzalez
2018-07-01
NCT02891278 COMPLETED
Acute Myeloid Leukemia
Columbia University
2016-08-11 PHASE1
NCT03414931 COMPLETED
Depressive Disorder, Major
Chang Gung Memorial Hospital
2016-01 PHASE2
NCT02452983 TERMINATED
Myelodysplastic Syndromes
Gustavo Rivero
2015-05 PHASE1
NCT04094870 COMPLETED
Perinatal Depression; HIV-1-infection
University of North Carolina, Chapel Hill
2019-10-30 PHASE4
NCT04171193 UNKNOWN
Depressive Disorder, Major; Treatment Resistant Depression; Depressive Episode
University of Sao Paulo
2019-12 PHASE2
NCT02955719 COMPLETED
Depression; Anxiety; Mild Cognitive Impairment
Centre for Addiction and Mental Health
2016-03-30
NCT05210153 Recruiting
Depressive Disorder Major
University of Belgrade|Clinical Centre of Serbia|Institute of Mental Health Serbia|Military Medical Academy Belgrade Serbia
2020-07-16 --
NCT03469128 COMPLETED
Psychologic Manipulation
British University In Egypt
2016-01-01 PHASE1
NCT04147000 Terminated
Overweight|Depression|Anxiety Disorders
Linkoeping University|Örebro University Sweden
2020-01-01 --
NCT03068429 COMPLETED
Obsessive-Compulsive Disorder
University of Sao Paulo
2016-12-01 PHASE4
NCT02189213 TERMINATED
Generalized Anxiety Disorder; Separation Anxiety Disorder; Social Phobia
New York State Psychiatric Institute
2014-07
NCT00693849 UNKNOWN
Major Depressive Disorder
BRC Operations Pty. Ltd.
2008-09 PHASE4
NCT02185547 TERMINATED
Pregnancy; Moderate Depression
Katarina Wide
2016-02-21 PHASE4
NCT02655354 COMPLETED
Posttraumatic Stress Disorder; Depression; Alcohol-Related Disorders; Suicidal Ideation; Substance-Related Disorders; Mild Cognitive Impairment; Quality of Life; Pain; Wounds and Injury; Brain Injuries; Chronic Disease
University of Washington
2015-10
NCT02813447 TERMINATED
COPD; Anxiety; Depression; Stress; Interstitial Lung Disease
Duke University
2016-08
NCT02908334 WITHDRAWN
Coccidioidomycosis
University of California, San Francisco
2016-11 PHASE2
NCT04076371 COMPLETED
Schizophrenia
Beijing HuiLongGuan Hospital
2012-01
NCT03179839 COMPLETED
Obsessive-Compulsive Disorder
Shanghai Mental Health Center
2017-01-20
NCT03033069 COMPLETED
Stress Disorders, Post-Traumatic
Otsuka Pharmaceutical Development & Commercialization, Inc.
2017-01-26 PHASE2
NCT03711708 Completed
Healthy
Pfizer''s Upjohn has merged with Mylan to form Viatris Inc.|Pfizer
2018-11-06 Phase 4
NCT02770378 COMPLETED
Glioblastoma
University of Ulm
2016-11 PHASE1; PHASE2
NCT02385799 COMPLETED
Autism Spectrum Disorder
Randi J. Hagerman, MD
2015-04 PHASE2
NCT02641652 UNKNOWN
Hypertension
University Hospital Olomouc
2017-11 PHASE4
NCT02269540 COMPLETED
Major Depressive Disorder
Centre for Addiction and Mental Health
2014-10 EARLY_PHASE1
NCT01703039 TERMINATED
Major Depressive Disorder
Brigham and Women's Hospital
2013-01 PHASE2
NCT03002012 TERMINATED
Cryptococcosis; Cryptococcal Infections; AIDS-Related Opportunistic Infections
University of Minnesota
2017-11-15 PHASE3
NCT02417064 COMPLETED
Treatment-resistant Depression
Janssen Research & Development, LLC
2015-08-10 PHASE3
NCT01305889 COMPLETED
Major Depressive Disorder
University of California, San Francisco
2011-03
NCT02493868 COMPLETED
Depressive Disorder, Treatment-Resistant
Janssen Research & Development, LLC
2015-10-01 PHASE3
NCT03342963 COMPLETED
Healthy Male Adults
Otsuka Pharmaceutical Co., Ltd.
2017-11-21 PHASE1
NCT00182533 TERMINATED
Phobia, Social; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder; Anxiety Disorders; Major Depressive Disorder
Hamilton Health Sciences Corporation
2002-07 PHASE4
NCT01427608 COMPLETED
Psychotic Depression
Weill Medical College of Cornell University
2011-10 PHASE4
NCT02022709 COMPLETED
Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders
Shanghai Mental Health Center
2014-01 PHASE4
NCT02358343 COMPLETED
Depression; End Stage Renal Disease
University of Washington
2015-03-23 PHASE3
NCT02497287 COMPLETED
Treatment-resistant Depression
Janssen Research & Development, LLC
2015-09-30 PHASE3
NCT03514810 COMPLETED
Major Depressive Disorder
Kufa University
2017-01-10 PHASE1
NCT01802385 COMPLETED
Cryptococcal Meningitis; Fungal Meningitis
University of Minnesota
2015-03-09 PHASE3
NCT02422186 COMPLETED
Depressive Disorder, Treatment-Resistant
Janssen Research & Development, LLC
2015-08-20 PHASE3
NCT03978286 COMPLETED
Depression; Type 2 Diabetes Mellitus
Universidad Juárez Autónoma de Tabasco
2016-06-30 PHASE4
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
2015-01 PHASE3
NCT02418585 COMPLETED
Treatment-resistant Depression
Janssen Research & Development, LLC
2015-08-07 PHASE3
NCT01360866 COMPLETED
Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
Otsuka Pharmaceutical Development & Commercialization, Inc.
2011-10 PHASE3
NCT02739061 COMPLETED
Obsessive-Compulsive Disorder
Shanghai Mental Health Center
2014-06-12
NCT02797808 COMPLETED
OCD
University of Minnesota
2013-08 PHASE1; PHASE2
NCT01600456 COMPLETED
Posttraumatic Stress Disorder
Case Western Reserve University
2011-03 PHASE3
NCT02268487 UNKNOWN
Major Depressive Disorder
University of Sao Paulo
2014-01 PHASE4
NCT01524133 COMPLETED
Posttraumatic Stress Disorder
VA Ann Arbor Healthcare System
2011-11 PHASE4
NCT00946998 COMPLETED
Chronic Kidney Disease; Depression
VA Office of Research and Development
2010-02-08 PHASE3
NCT02520726 TERMINATED
Post-traumatic Stress Disorder
University of Utah
2013-09 PHASE4
NCT02651623 COMPLETED
Healthy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2016-01 PHASE1
NCT02504931 COMPLETED
PTSD; Alcohol Use Disorder
The University of Texas Health Science Center at San Antonio
2011-04 PHASE4
NCT02228005 COMPLETED
Depression
University Health Network, Toronto
2014-07 PHASE4
NCT01896934 COMPLETED
Major Depressive Disorder
Vanderbilt University
2013-07 PHASE4
NCT01856127 TERMINATED
Sexual Dysfunction; Major Depressive Disorder
Thomas Jefferson University
2013-01 PHASE4
NCT01407094 COMPLETED
Depression
University of Texas Southwestern Medical Center
2011-07-29 PHASE2
NCT02469545 COMPLETED
Depression; Anxiety Disorder
Medical University of Bialystok
2014-06 PHASE2
NCT02347033 TERMINATED
Generalised Anxiety Disorder
University College, London
2014-08 PHASE4
NCT02463110 TERMINATED
Depression; Coronary Artery Disease
Assistance Publique - Hôpitaux de Paris
2015-07 PHASE4
NCT01987960 TERMINATED
Post-traumatic Stress Disorder; PTSD
H. Lundbeck A/S
2013-12 PHASE3
NCT01109693 COMPLETED
Unipolar Major Depressive Episode
Kyoto University
2010-12 PHASE4
NCT01474746 COMPLETED
Fragile X Syndrome
Randi J. Hagerman, MD
2012-01 PHASE2
NCT02235064 TERMINATED
Depression, Postpartum
The Cooper Health System
2014-07
NCT02565316 COMPLETED
Depression; Anxiety
Shiraz University of Medical Sciences
2014-11 PHASE2; PHASE3
NCT01794455 TERMINATED
Depression; Hypertension
Vanderbilt University
2013-05 PHASE4
NCT02237937 UNKNOWN
Major Depression
HolsboerMaschmeyer NeuroChemie GmbH
2011-09 PHASE4
NCT02918097 COMPLETED
Bipolar Disorder
Federal University of Rio Grande do Sul
2010-05 PHASE4
NCT02901249 COMPLETED
Depression
Federal University of Rio Grande do Sul
2010-05 PHASE4
NCT01669304 COMPLETED
Vestibular Migraine; Chronic Subjective Dizziness
Mayo Clinic
2012-08 PHASE1
NCT01569685 COMPLETED
Post Traumatic Stress Disorder; Depression
Charlotte Sonne
2012-04 PHASE4
NCT01764867 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
2012-06 PHASE4
NCT01977729 TERMINATED
Anxiety Disorder of Adolescence
Yale University
2013-10 PHASE2
NCT02175602 COMPLETED
Hepatitis C Infection
Bristol-Myers Squibb
2014-06 PHASE1
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
2013-04
NCT01214382 COMPLETED
Roux en Y Gastric Bypass Surgery
North Dakota State University
2010-10 PHASE3
NCT00602355 COMPLETED
Depression, Postpartum
Women and Infants Hospital of Rhode Island
2008-02 PHASE2
NCT01178671 COMPLETED
Posttraumatic Stress Disorder
Research Foundation for Mental Hygiene, Inc.
2010-07 PHASE4
NCT00704379 COMPLETED
Traumatic Brain Injury
Baylor College of Medicine
2008-06 PHASE2; PHASE3
NCT02179268 COMPLETED
Bone Mineral Density Quantitative Trait Locus 7
Guiyang Medical University
2012-03 PHASE3
NCT00917397 COMPLETED
Post-Traumatic Stress Disorder
Caecilie Buhmann
2009-06 PHASE4
NCT01287494 UNKNOWN
Depression
Zhejiang University
2010-08 PHASE4
NCT01027559 COMPLETED
Major Depression; Treatment
Washington University School of Medicine
2009-02
NCT02088697 COMPLETED
Healthy Volunteers
Otsuka Pharmaceutical Co., Ltd.
2013-12 PHASE1
NCT01769027 WITHDRAWN
Pandas
CNS Onlus
2013-06 PHASE2
NCT00744328 TERMINATED
Postpartum Depression
Northwestern University
2008-08 PHASE4
NCT01437189 COMPLETED
Depression; Parkinson's Disease
Zhejiang University
2011-08-01
NCT01751828 WITHDRAWN
Depression
Vanderbilt University
2012-12
NCT00262223 COMPLETED
Stress Disorders, Post-Traumatic; Alcohol Abuse; Substance-Related Disorders
New York State Psychiatric Institute
2006-05 PHASE2
NCT01098318 COMPLETED
Depression
University of Pennsylvania
2010-06 PHASE3
NCT00834652 COMPLETED
Depression
Washington University School of Medicine
2007-09 PHASE4
NCT00531518 COMPLETED
Schizophrenia; Bipolar Disorder; Depression; Psychotic Disorders
MaineHealth
2007-10
NCT00178828 COMPLETED
Depression
Vanderbilt University Medical Center
2002-10 PHASE4
NCT00955474 TERMINATED
Major Depressive Disorder With Psychotic Features
Massachusetts General Hospital
2008-09 PHASE4
NCT00835627 COMPLETED
Convulsion, Non-Epileptic; Conversion Disorder; Depression; Stress Disorders, Post-Traumatic; Dissociative Disorders
Rhode Island Hospital
2008-09 PHASE4
NCT01309074 WITHDRAWN
Epilepsy; Anxiety
Rush University Medical Center
2009-11 PHASE4
NCT02473783 COMPLETED
Major Depressive Disorder
Tri-Service General Hospital (TSGH)
2011-10 PHASE2
NCT01467804 UNKNOWN
Depressive Disorder
Su Rui
2011-11
NCT01699724 COMPLETED
Healthy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2012-09 PHASE1
NCT01254305 COMPLETED
Major Depressive Disorder
Forest Laboratories
2011-04 PHASE2
NCT01032434 COMPLETED
Depression
Guang Dong Provincial Mental Health Institute
2009-12
NCT00276965 COMPLETED
Bipolar Disorder; Depression
Lindner Center of HOPE
2006-09 PHASE3
NCT01113164 COMPLETED
Alcoholism
Brown University
2008-09 PHASE1
NCT00536198 COMPLETED
Premenstrual Dysphoric Disorder
Yale University
2007-11-06 PHASE4
NCT01032018 COMPLETED
Acute Coronary Syndrome; Depression
Columbia University
2010-01 PHASE1; PHASE2
NCT00581009 COMPLETED
Major Depressive Disorder; Bipolar Disorder
University of California, Irvine
2001-05-30 PHASE1; PHASE2
NCT00282828 COMPLETED
Social Phobia
Massachusetts General Hospital
2006-03 PHASE4
NCT01033084 COMPLETED
Depressive Disorder, Major
University of Sao Paulo
2009-12 PHASE2; PHASE3
NCT00127673 COMPLETED
Post-Traumatic Stress Disorder
Case Western Reserve University
2004-09 PHASE3
NCT00302068 COMPLETED
Depression; Heart Diseases
Duke University
2006-07 PHASE3
NCT00857584 COMPLETED
Bipolar Disorder; Bipolar Depression
AstraZeneca
2009-05 PHASE3
NCT01250873 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
2010-11 PHASE1
NCT01235195 COMPLETED
Healthy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2010-11 PHASE1
NCT00519012 UNKNOWN
Depression
Oizumi Hospital
2007-08 PHASE4
NCT00594269 COMPLETED
Dementia
Sykehuset Innlandet HF
2008-08 PHASE4
NCT01028482 COMPLETED
Postpartum Depression
Tel-Aviv Sourasky Medical Center
2008-03
NCT01155531 COMPLETED
Obesity
Theracos
2010-05 PHASE1
NCT00612807 COMPLETED
Major Depressive Disorder; Partner Relational Disorder (V61.10)
Duke University
2006-07 PHASE1; PHASE2
NCT01454635 COMPLETED
Major Depressive Disorder
Showa University
2008-06
NCT00510822 COMPLETED
Major Depression
Affectis Pharmaceuticals AG
2007-10 PHASE2
NCT00677352 COMPLETED
Panic Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2008-05 PHASE4
NCT00969852 COMPLETED
Healthy
Seoul National University Hospital
2009-07 PHASE4
NCT00701675 COMPLETED
Generalized Anxiety Disorder
VA Office of Research and Development
2005-10 PHASE4
NCT00391430 TERMINATED
Post-Traumatic Stress Disorder
NYU Langone Health
2005-05 PHASE4
NCT00116857 COMPLETED
Cardiovascular Diseases; Depression; Heart Diseases; Myocardial Infarction; Angina, Unstable
Washington University School of Medicine
2005-02 PHASE3
NCT00043550 COMPLETED
Depression
University of Pennsylvania
2001-11 PHASE3
NCT00368550 COMPLETED
Alcoholism
UConn Health
2004-02 PHASE4
NCT00654953 COMPLETED
Cocaine Dependence; Depressive Symptoms
University of Arkansas
2006-01 PHASE2
NCT00232284 COMPLETED
Depression; Substance-Related Disorders
Dan Lubman
2004-09 PHASE2
NCT00873795 COMPLETED
Major Depressive Disorder
Chimei Medical Center
2007-04
NCT00666757 COMPLETED
Depression
Eli Lilly and Company
2008-05 PHASE4
NCT00208117 TERMINATED
Depression; Coronary Artery Disease (CAD); Acute Coronary Syndrome (ACS)
New York State Psychiatric Institute
2005-04 PHASE1
NCT00215150 COMPLETED
Social Anxiety Disorder
Duke University
2004-11 PHASE2
NCT00624013 COMPLETED
Diabetes; Depression
Charles Drew University of Medicine and Science
2006-09 PHASE4
NCT00233103 COMPLETED
Depression
Icahn School of Medicine at Mount Sinai
2003-06 PHASE2
NCT00680602 COMPLETED
Obsessive Compulsive Disorder
University of Sao Paulo
2006-01 PHASE4
NCT00245557 COMPLETED
Major Depressive Disorder
Mclean Hospital
2004-11
NCT00086138 COMPLETED
Alzheimer's Disease; Depression
Johns Hopkins University
2004-07 PHASE2; PHASE3
NCT00159965 COMPLETED
Convulsion, Non-Epileptic; Conversion Disorder; Depression; Stress Disorders, Post-Traumatic
Rhode Island Hospital
2003-12 PHASE4
NCT00056472 COMPLETED
Major Depressive Disorder With Psychotic Features
Weill Medical College of Cornell University
2003-01 PHASE3
NCT00078286 COMPLETED
Heart Failure, Congestive; Chronic Heart Failure; Depression
Duke University
2003-11 PHASE2; PHASE3
NCT00318773 COMPLETED
Premenstrual Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2002-02 PHASE4
NCT00299611 TERMINATED
Obsessive-Compulsive Disorder
Duke University
2005-11 PHASE2; PHASE3
NCT00052078 COMPLETED
Anxiety Disorders; Social Phobia; Generalized Anxiety Disorder
Johns Hopkins University
2003-01 PHASE3
NCT00118417 COMPLETED
Panic Disorder
Massachusetts General Hospital
1999-03 PHASE2; PHASE3
NCT00177424 TERMINATED
Cerebrovascular Accident; Depression
University of Pittsburgh
2004-07 PHASE4
NCT00048854 COMPLETED
Premenstrual Syndrome
Yale University
2001-09 PHASE1; PHASE2
NCT00375843 COMPLETED
Depression
National Institute of Mental Health (NIMH)
2005-01 PHASE4
NCT00026637 COMPLETED
Depression; Epilepsy
Columbia University
2001-08 PHASE3
NCT00284791 TERMINATED
Adolescent Depression
MaineHealth
2006-01
NCT00177996 COMPLETED
Major Depression
University of Pittsburgh
2001-10 PHASE4
NCT00009191 COMPLETED
Alzheimer Disease; Depression
Johns Hopkins University
2005-11 PHASE4
NCT00234312 COMPLETED
Depression; Dysthymia
Oregon Health and Science University
2005-09 PHASE4
NCT01267383 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2006-09 PHASE1
NCT01267396 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2006-09 PHASE1
NCT00133822 COMPLETED
Post-Traumatic Stress Disorders
Emory University
2004-04 PHASE1; PHASE2
NCT00655174 COMPLETED
Autism
The Hospital for Sick Children
1999-06 PHASE3
NCT00744406 COMPLETED
Depression; Major Depressive Disorder
Centre for Addiction and Mental Health
2003-07 PHASE2
NCT00057642 COMPLETED
Depression; Depressive Disorder
New York State Psychiatric Institute
2002-09
NCT00276900 COMPLETED
Depression
University of Pittsburgh
2003-12 PHASE3
NCT00182078 COMPLETED
Posttraumatic Stress Disorder; Depression
Massachusetts General Hospital
2002-11 PHASE4
NCT00078767 COMPLETED
Stress Disorders, Post-Traumatic
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
2001-04 PHASE3
NCT00229476 COMPLETED
Depressive Disorder, Major
University of California, Los Angeles
2003-12 PHASE4
NCT00339066 COMPLETED
Depression
Duke University
2001-08
NCT00249431 TERMINATED
Alcoholism; Gambling
New York State Psychiatric Institute
2001-12 PHASE2
NCT00778973 COMPLETED
Healthy
Ranbaxy Laboratories Limited
2005-08
NCT00004554 COMPLETED
Alcoholism; Depression
University of Pennsylvania
2000-01 PHASE4
NCT00340379 COMPLETED
Affective Disorders
Duke University
2003-04 PHASE2; PHASE3
NCT00779350 COMPLETED
Healthy
Ranbaxy Laboratories Limited
2005-08
NCT00000451 COMPLETED
Alcoholism; Alcohol Dependence
Yale University
2003-01 PHASE2
NCT00066859 COMPLETED
Depression; Unspecified Adult Solid Tumor, Protocol Specific
Wake Forest University Health Sciences
2004-03-01 PHASE3
NCT02122393 COMPLETED
Depression; Anxiety
University of Melbourne
2002-04 PHASE3
NCT00864019 COMPLETED
Healthy
Actavis Inc.
2004-08 PHASE1
NCT00864344 COMPLETED
Healthy
Actavis Inc.
2004-08 PHASE1
NCT00118014 COMPLETED
Impulse Control Disorders
Massachusetts General Hospital
2000-01 PHASE4
NCT00602849 COMPLETED
Depression
Roxane Laboratories
2003-06
NCT00601588 COMPLETED
Depression
Roxane Laboratories
2003-06
NCT00208702 COMPLETED
Major Depression
Emory University
1996-09 PHASE4
NCT01114100 COMPLETED
Panic Attacks; Chest Pain; Depression
Maastricht University Medical Center
2000-01 PHASE4
NCT00650325 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2002-11 PHASE1
NCT00648856 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2002-12 PHASE1
NCT00000378 COMPLETED
Depression; Melancholia
New York State Psychiatric Institute
1997-07 PHASE4
NCT00836849 COMPLETED
Healthy
Teva Pharmaceuticals USA
2002-03 PHASE1
NCT00836667 COMPLETED
Healthy
Teva Pharmaceuticals USA
2002-03 PHASE1
NCT00015132 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
1999-03 PHASE2
NCT00491478 UNKNOWN
Mental Retardation; Stereotyped Behavior; Self-Injurious Behavior; Compulsive Behavior
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1992-09 PHASE3
NCT00374426 COMPLETED
Major Depression; Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1998-03 PHASE4
NCT00406952 COMPLETED
Depressive Disorder, Major
Pfizer
2006-11
NCT00283192 COMPLETED
Menopause-Hot Flashes
University of California, San Francisco
2003-07
NCT00325000 TERMINATED
Major Depression
German Research Foundation
2000-11
NCT00263133 COMPLETED
Depression
University Hospital Freiburg
2005-12
NCT00208585 UNKNOWN
Traumatic Brain Injury
Walter Reed Army Medical Center
2000-02
NCT00215241 COMPLETED
Post-Traumatic Stress Disorder
Duke University
2004-04 PHASE2; PHASE3
NCT00331305 COMPLETED
Depression
Duke University
1999-08 PHASE3
NCT00058903 COMPLETED
Pruritus; Liver Cirrhosis, Biliary; Hepatitis C
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2003-04 PHASE2
NCT00198094 COMPLETED
Panic Disorder
Indiana University
2003-12 PHASE4
NCT00158990 COMPLETED
Major Depression; Bipolar Disorder; Unipolar Depression
Hadassah Medical Organization
2002-10 PHASE3
NCT00169988 COMPLETED
Prodromal Schizophrenia; Psychotic Disorders
Northwell Health
2004-03
NCT00944242 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
PHASE1
NCT00001777 COMPLETED
Dementia
National Institute of Neurological Disorders and Stroke (NINDS)
1997-12 PHASE1
NCT00508859 COMPLETED
Depression
Sunnybrook Health Sciences Centre
1997-07 PHASE4
NCT00050804 COMPLETED
Acute Traumatic Stress Disorders; Post-Traumatic Stress Disorders
National Institute of Mental Health (NIMH)
2002-12 PHASE4
NCT00000384 COMPLETED
Obsessive-Compulsive Disorder
University of Pennsylvania
1997-05 PHASE3
NCT00000458 COMPLETED
Alcoholism; Depression
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
PHASE2
NCT00000440 COMPLETED
Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
PHASE2
NCT00080158 COMPLETED
Depression; Suicide, Attempted
New York State Psychiatric Institute
2004-03 PHASE2; PHASE3
NCT00644982 COMPLETED
Depressive Disorder, Major
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2002-10 PHASE4
NCT00150306 TERMINATED
Stress Disorders, Post-Traumatic
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2002-11 PHASE3
NCT00001483 COMPLETED
Bipolar Disorder; Depressive Disorder
National Institute of Mental Health (NIMH)
1995-06 PHASE2
NCT00000446 COMPLETED
Alcoholism; Post-Traumatic Stress Disorder
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
PHASE2
NCT00636246 COMPLETED
Depressive Disorder, Major
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2004-06 PHASE2
NCT00275197 COMPLETED
Depressive Disorder, Major
Pfizer
2005-12 PHASE2
NCT00174590 TERMINATED
Major Depression With Psychotic Features
Rush University Medical Center
2001-09 PHASE3
NCT00179257 COMPLETED
Major Depressive Disorder
Vanderbilt University
2004-06 PHASE3
NCT00351910 COMPLETED
Major Depressive Disorder
AstraZeneca
2006-05 PHASE3
NCT00485862 COMPLETED
Depressive Symptoms
Eli Lilly and Company
2003-06 PHASE4
NCT00021528 COMPLETED
Depression
National Institute of Mental Health (NIMH)
2001-07 PHASE4
NCT00946036 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
PHASE1
NCT00005013 COMPLETED
Major Depression
National Institute of Mental Health (NIMH)
1998-12
NCT00232167 TERMINATED
Insomnia; Depression
Neurocrine Biosciences
2005-11 PHASE3
NCT00143091 TERMINATED
Depressive Disorder, Major
Pfizer
2005-04 PHASE2
NCT00179283 COMPLETED
Major Depressive Disorder
Vanderbilt University
2002-04 PHASE3
NCT00421369 COMPLETED
Major Depressive Disorder
Hadassah Medical Organization
2007-09
NCT00004300 SUSPENDED
Stereotyped Behavior; Mental Retardation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PHASE2

(data from https://clinicaltrials.gov, updated on 2025-10-08)

Check the Sertraline HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sertraline HCl acts as a 5-HT antagonist with an affinity Ki of 13 nM, binding serotonin targets to attenuate downstream serotonergic biochemical cascades and alter synaptic neurotransmission. This modulation of central signaling pathways reduces neuronal hyperresponsiveness and restores emotional signaling networks, supporting its therapeutic activity in major depressive disorder, anxiety disorders, and post-traumatic stress 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>).

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