Clinical Trials

Escitalopram has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, investigating psychiatric and neurological conditions—such as major depressive disorder, obsessive-compulsive disorder, posttraumatic stress disorder, ischemic stroke, and Alzheimer's-associated depressive symptoms—alongside pharmacokinetic studies in healthy volunteers. Funded by both academic institutions and commercial pharmaceutical sponsors, these studies encompass diverse recruitment statuses, including actively recruiting, completed, active non-recruiting, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06433635 ACTIVE_NOT_RECRUITING
Bipolar I Disorder; Depression
Massachusetts General Hospital
2024-10-01 PHASE4
NCT05901571 NOT_YET_RECRUITING
Depressive Disorder, Major
Shanghai 7th People's Hospital
2026-11
NCT05017311 RECRUITING
Major Depressive Disorder
Nova Scotia Health Authority
2023-01-20 PHASE4
NCT06216535 RECRUITING
Asthma
University of Texas Southwestern Medical Center
2025-05-19 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
NCT04336228 ACTIVE_NOT_RECRUITING
Obsessive-Compulsive Disorder/High Compulsive Individuals; Healthy Individuals
Rigshospitalet, Denmark
2020-04-01 PHASE4
NCT07478796 RECRUITING
Depression - Major Depressive Disorder; Depressive Episodes
Poznan University of Medical Sciences
2025-04-03 PHASE4
NCT06210321 NOT_YET_RECRUITING
Pharmacogenetic Testing
Chantal Csajka
2025-08-15
NCT07139834 RECRUITING
Major Depressive Disorder (MDD)
Jeffrey Miller
2026-06-01 PHASE1
NCT03728673 RECRUITING
Glioma of Brain; Glioma
University of Nebraska
2019-03-06 PHASE2
NCT03843463 RECRUITING
Aphasia; Stroke
Johns Hopkins University
2021-07-18 PHASE2
NCT07645807 NOT_YET_RECRUITING
Adjunct in the Treatment of Depressive Disorder
Sichuan Credit Pharmaceutical Co., Ltd.
2026-06-11
NCT05004987 RECRUITING
Alzheimer Disease; Major Depressive Disorder
NYU Langone Health
2022-02-04 PHASE4
NCT07025590 RECRUITING
Cardiovascular Diseases (CVD); Depression Anxiety Disorder
Guangdong Provincial People's Hospital
2025-04-22
NCT07480525 RECRUITING
Depression - Major Depressive Disorder
Peking University
2026-03-20
NCT05480150 RECRUITING
Major Depressive Disorder; Bipolar Disorder, Mixed; Affective; Disorder, Organic
First Affiliated Hospital of Zhejiang University
2021-11-01
NCT06826326 ENROLLING_BY_INVITATION
Autism Spectrum Disorder
Kathryn Unruh
2025-04-28 PHASE2
NCT05737511 NOT_YET_RECRUITING
Panic Disorder
Sultan Qaboos University
2023-12-30 PHASE4
NCT07331987 RECRUITING
Anxiety Depression
Moon (Guangzhou) Biotechnology Co., Ltd.
2026-06-15
NCT06705478 SUSPENDED
Major Depressive Disorder; Mild Neurocognitive Disorder; HIV
National Institute of Allergy and Infectious Diseases (NIAID)
2026-05-17 PHASE2
NCT07432815 RECRUITING
Depression; Anxiety; Psoriasis
Cairo University
2026-02-01 PHASE4
NCT06796946 NOT_YET_RECRUITING
Deprescription; Antidepressants
University of Huelva
2026-06 EARLY_PHASE1
NCT06675851 RECRUITING
Major Depressive Disorder (MDD)
Medical University of Vienna
2022-12-01 PHASE4
NCT05866575 RECRUITING
Major Depressive Disorder
Centre Hospitalier St Anne
2023-09-12
NCT06828887 RECRUITING
MDD
Vigonvita Life Sciences
2025-04-03 PHASE2
NCT04623099 RECRUITING
Anxiety
University of Cincinnati
2021-03-08 PHASE4
NCT06692361 RECRUITING
Major Depressive Disorder (MDD); Depression - Major Depressive Disorder
Gang Wang
2025-01-01
NCT06937476 ACTIVE_NOT_RECRUITING
Major Depressive Disorder (MDD); Rumination
Central South University
2025-05-08
NCT07590609 COMPLETED
Liver-Stagnation and Spleen-Deficiency; Severe Major Depression Disorder
Peking University Sixth Hospital
2023-05-23 PHASE4
NCT05818735 UNKNOWN
Depression
Shanghai Municipal Hospital of Traditional Chinese Medicine
2023-12-01
NCT06965569 COMPLETED
Treatment Resistant Depression
Alar Pharmaceuticals Inc.
2025-04-21 PHASE1
NCT06696482 NOT_YET_RECRUITING
Effort Based Decision Making; Prosocial Behavior; Apathy
University of Oxford
2025-01 PHASE1; PHASE2
NCT04245748 UNKNOWN
Anxious Depression; Depression
University of Cincinnati
2020-03-01 PHASE4
NCT04245436 UNKNOWN
Anxiety; Depressive Symptoms
University of Cincinnati
2020-01-01 PHASE4
NCT05536414 COMPLETED
Major Depressive Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.
2022-09-12 PHASE2
NCT07628153 COMPLETED
Anxiety Disorders
I.M. Sechenov First Moscow State Medical University
2022-07-11 PHASE4
NCT06476509 COMPLETED
Major Depressive Disorder
Vigonvita Life Sciences
2024-05-30 PHASE1
NCT05945342 UNKNOWN
Depressive Disorder; Adolescent
First Affiliated Hospital of Zhejiang University
2023-01-31
NCT04156425 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
2020-07-01
NCT04410341 WITHDRAWN
Major Depressive Disorder
Sadat City University
2020-05-01 PHASE1; PHASE2
NCT05389046 UNKNOWN
Outpatients / Inpatients With Depression
Peking University
2022-08-15
NCT06680531 COMPLETED
Insomnia; Central Nervous System
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
2024-08-31 PHASE1
NCT06500624 COMPLETED
Depression
Riphah International University
2024-06-03
NCT04301271 COMPLETED
Depressive Disorder, Major; Obesity
Charite University, Berlin, Germany
2020-08-13 PHASE2
NCT03108846 ACTIVE_NOT_RECRUITING
Dementia
JHSPH Center for Clinical Trials
2018-01-03 PHASE3
NCT06758167 COMPLETED
Major Depression
Peking University Sixth Hospital
2020-11-14
NCT06025474 UNKNOWN
Burning Mouth Syndrome
Federico II University
2023-01-01 PHASE3
NCT05470465 COMPLETED
Hypercapnia; Ventilatory Depression
Food and Drug Administration (FDA)
2022-09-01 PHASE1
NCT05289830 TERMINATED
Pancreatic Ductal Adenocarcinoma; Periampullary Cancer
Case Comprehensive Cancer Center
2022-08-05 PHASE2
NCT03128021 COMPLETED
Major Depressive Disorder
Howard Aizenstein
2017-05-24 PHASE4
NCT04388202 WITHDRAWN
Major Depressive Disorder
Alto Neuroscience
2020-10-15 PHASE4
NCT05588102 COMPLETED
Geriatric Depression; Cognitive Impairment
Capital Medical University
2021-05-18
NCT03527043 TERMINATED
Sperm DNA Fragmentation; Infertility, Male
Weill Medical College of Cornell University
2017-10-01 PHASE2
NCT05480878 COMPLETED
Rheumatoid Arthritis
Tanta University
2022-12-02 PHASE3
NCT03779789 COMPLETED
Major Depressive Disorder
Azienda Ospedaliera Universitaria Integrata Verona
2019-02-01 PHASE4
NCT03652870 COMPLETED
Depression; Parkinson Disease
University College, London
2021-03-05 PHASE3
NCT04977232 COMPLETED
Depression
Central South University
2021-09-09
NCT03623711 UNKNOWN
Major Depressive Disorder; Depression, Unipolar
Yuqi Cheng
2018-08-01 EARLY_PHASE1
NCT04162522 COMPLETED
Major Depressive Disorder
University Health Network, Toronto
2019-12-23 PHASE3
NCT05145270 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
2019-11-30 PHASE4
NCT06325605 COMPLETED
Adolescent Depression
Zhen-Hong Hu
2022-03-01
NCT04239339 COMPLETED
Healthy
Rigshospitalet, Denmark
2020-04-28 PHASE4
NCT05950061 COMPLETED
Major Depressive Disorder
KRL Hospital, Islamabad
2022-06-01 PHASE3
NCT04352101 COMPLETED
Major Depression
Emory University
2020-09-23 PHASE4
NCT02389465 COMPLETED
Depression; Inflammation
University of Pennsylvania
2014-08 PHASE4
NCT02553161 COMPLETED
Depression; Anxiety; Bipolar Disorder
University of Cincinnati
2015-12
NCT07074652 COMPLETED
Anxiety
UCLH/UCL Joint Research Office
2017-12-01
NCT02532660 TERMINATED
Depression
Laboratório Catarinense SA
2018-07-02 PHASE3
NCT07077291 COMPLETED
Treatment-resistant Depression (TRD)
Yun Zhang
2020-02-01
NCT02620150 COMPLETED
Depression; HIV; AIDS
University of Pennsylvania
2017-02-16 PHASE4
NCT03993457 TERMINATED
Depression
University of Texas Southwestern Medical Center
2019-07-23 PHASE4
NCT03899194 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
2019-01-01
NCT04069819 COMPLETED
Major Depressive Disorder
Sadat City University
2019-08-01
NCT03148522 UNKNOWN
Diagnosis and Treatment of Depression
Peking University
2017-06-01
NCT04763135 TERMINATED
Cancer; Neoplasms; Neoplasm Metastasis
Hospices Civils de Lyon
2021-12-15 PHASE3
NCT03346239 COMPLETED
Social Anxiety Disorder
Tel Aviv University
2018-07-20
NCT03522844 COMPLETED
Anxiety Disorders; Generalized Anxiety Disorder; Panic Disorder; Social Anxiety Disorder; Agoraphobia
Georgetown University
2018-06-18 PHASE4
NCT04476030 COMPLETED
Depressive Disorder, Major
Biogen
2020-11-09 PHASE3
NCT03924323 COMPLETED
Anxiety Disorders,Generalized Anxiety Disorder
AbbVie
2019-05-30 PHASE4
NCT03852160 WITHDRAWN
Depressive Disorder, Treatment-Resistant
Janssen-Cilag International NV
2019-12-01 PHASE3
NCT03909217 COMPLETED
Mild-to-moderate Depression
The University of Hong Kong
2019-07-29 PHASE2; PHASE3
NCT03841474 UNKNOWN
Coronary Artery Disease; Depression; Cardiovascular Diseases
Klinički Bolnički Centar Zagreb
2021-03-01
NCT03321006 COMPLETED
Hearing Loss; Depression
New York State Psychiatric Institute
2018-05-30 PHASE4
NCT04697693 TERMINATED
Post Traumatic Stress Disorder; Major Depressive Disorder
New York State Psychiatric Institute
2021-03-03 PHASE4
NCT02674529 COMPLETED
Major Depressive Disorder
Marta Peciña, MD PhD
2016-09 PHASE2; PHASE3
NCT03434041 COMPLETED
Depressive Disorder, Treatment-Resistant
Janssen Research & Development, LLC
2018-05-25 PHASE3
NCT03887624 COMPLETED
Depressive Disorder, Treatment-Resistant
Zhejiang University
2019-05-21 EARLY_PHASE1
NCT04221256 WITHDRAWN
Stroke, Ischemic
Burke Medical Research Institute
2020-03-11 PHASE1; PHASE2
NCT04037111 UNKNOWN
Major Depressive Disorder; Rheumatoid Arthritis
Xijing Hospital
2019-07-23
NCT03912974 COMPLETED
Healthy
University Hospital, Basel, Switzerland
2019-07-04 PHASE1
NCT02332291 COMPLETED
Major Depressive Disorder
Vanderbilt University Medical Center
2015-04 PHASE4
NCT04234776 UNKNOWN
Depressive Disorder
University of Sao Paulo
2018-04-03 PHASE4
NCT03812588 COMPLETED
Major Depressive Disorder
New York State Psychiatric Institute
2019-01-30 PHASE4
NCT03429075 COMPLETED
Depressive Disorder, Major
Imperial College London
2019-01-07 PHASE2
NCT00958633 TERMINATED
Bipolar I Disorder
University of British Columbia
2010-11 PHASE3
NCT02623205 COMPLETED
Depression
Stony Brook University
2015-05 PHASE4
NCT03487211 COMPLETED
Fibromyalgia
Shaheed Zulfiqar Ali Bhutto Medical University
2018-04-09 PHASE2; PHASE3
NCT02711215 UNKNOWN
Major Depressive Disorder
Medical University of Vienna
2015-05 PHASE4
NCT00693849 UNKNOWN
Major Depressive Disorder
BRC Operations Pty. Ltd.
2008-09 PHASE4
NCT03274817 TERMINATED
Alzheimer Disease
NYU Langone Health
2009-06-18 PHASE1
NCT03464383 COMPLETED
Anxiety; Depression; Epilepsy
Wake Forest University Health Sciences
2018-05-07 PHASE4
NCT02753738 UNKNOWN
Ssri; Neuronal Plasticity
Medical University of Vienna
2016-08 PHASE4
NCT01728194 COMPLETED
Depression
Weill Medical College of Cornell University
2012-07 PHASE4
NCT02869035 COMPLETED
Major Depressive Disorder
Rigshospitalet, Denmark
2016-08 PHASE1
NCT03388164 TERMINATED
Depression
Laureate Institute for Brain Research, Inc.
2018-01-01 PHASE2
NCT04543123 COMPLETED
Major Depressive Disorder
Jeong-Ho Chae
2017-11-16 PHASE4
NCT02818751 COMPLETED
Anxiety
University of Cincinnati
2015-05
NCT03187093 UNKNOWN
Major Depressive Disorder
Oleg Levada
2016-10 PHASE4
NCT04093960 TERMINATED
Major Depression
Kaohsiung Kai-Suan Psychiatric Hospital
2016-11-18 PHASE4
NCT01902004 COMPLETED
Mild Cognitive Impairment (MCI); Depression
University of California, Los Angeles
2013-10 PHASE4
NCT01931202 COMPLETED
Major Depressive Disorder
New York State Psychiatric Institute
2014-02-19
NCT02153567 COMPLETED
Dyspepsia; Anxiety; Depression
Chinese University of Hong Kong
2013-12-06 PHASE3
NCT03122158 UNKNOWN
Major Depressive Disorder; Anxiety Disorders
Erzurum Regional Training & Research Hospital
2017-04-08 PHASE4
NCT03323697 UNKNOWN
Depression, Anxiety
Mazra Mental Health Center
2017-08-28 PHASE1; PHASE2
NCT03547219 COMPLETED
Depression; Adolescent
Seoul National University
2015-08-05
NCT00550485 COMPLETED
Pharmacokinetics
Max-Planck-Institute of Psychiatry
2007-10
NCT04013464 COMPLETED
Depressive Disorder, Major
Peking University Sixth Hospital
2016-05-01
NCT03522987 WITHDRAWN
Anxiety; Depression; Epilepsy
Wake Forest University Health Sciences
2018-05 PHASE4
NCT02417064 COMPLETED
Treatment-resistant Depression
Janssen Research & Development, LLC
2015-08-10 PHASE3
NCT02493868 COMPLETED
Depressive Disorder, Treatment-Resistant
Janssen Research & Development, LLC
2015-10-01 PHASE3
NCT03131050 COMPLETED
Major Depressive Disorder
Capital Medical University
2017-03-15 PHASE4
NCT03010761 TERMINATED
Addiction
China Medical University Hospital
2016-01-14 PHASE2
NCT01479829 COMPLETED
Bipolar Depression
Loyola University
2011-03-23 PHASE4
NCT03554447 COMPLETED
Major Depressive Disorder
Mahmoud Samy Abdallah
2015-04-20
NCT02623231 UNKNOWN
GBM; Depression
Tel-Aviv Sourasky Medical Center
2015-12 PHASE2; PHASE3
NCT03162185 UNKNOWN
Healthy Controls
Max Planck Institute for Human Cognitive and Brain Sciences
2017-04-01 PHASE4
NCT02497287 COMPLETED
Treatment-resistant Depression
Janssen Research & Development, LLC
2015-09-30 PHASE3
NCT05840692 COMPLETED
Polycystic Ovary Syndrome
Odense University Hospital
2013-08 PHASE4
NCT02422186 COMPLETED
Depressive Disorder, Treatment-Resistant
Janssen Research & Development, LLC
2015-08-20 PHASE3
NCT02161458 COMPLETED
Amyloid Beta Protein
University of Pennsylvania
2014-06 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
NCT01655706 COMPLETED
Major Depressive Disorder
University Health Network, Toronto
2012-04-23 PHASE3
NCT02407821 TERMINATED
End Stage Renal Disease
University Health Network, Toronto
2015-03 PHASE2
NCT01997580 UNKNOWN
Major Depressive Disorder
Seoul National University Bundang Hospital
2013-07 PHASE4
NCT02191397 COMPLETED
Depressive Disorder, Major
GlaxoSmithKline
2015-02-10 PHASE3
NCT01477203 COMPLETED
Major Depressive Disorder (MDD); Anxiety Disorder
Medical University of Vienna
2011-11 PHASE4
NCT01551225 COMPLETED
Irritable Bowel Syndrome; Panic Disorder
Maastricht University Medical Center
2012-01 PHASE4
NCT01787240 TERMINATED
Major Depressive Disorder
Massachusetts General Hospital
2012-11 PHASE4
NCT01894815 COMPLETED
Major Depressive Disorder; Major Depressive Disorder, Recurrent, Unspecified; Major Depressive Disorder, Single Episode, Unspecified
University of Sao Paulo
2013-10 PHASE3
NCT01594866 COMPLETED
Major Depressive Disorder
Seoul National University Hospital
2012-05 PHASE4
NCT02469545 COMPLETED
Depression; Anxiety Disorder
Medical University of Bialystok
2014-06 PHASE2
NCT02272517 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
2014-12 PHASE3
NCT00584571 COMPLETED
Rectal Hypersensitivity; Irritable Bowel Syndrome-Constipation
Augusta University
2007-12 PHASE2
NCT02423694 UNKNOWN
Perimenopause; Depression
Guangdong Provincial Hospital of Traditional Chinese Medicine
2013-09
NCT02082392 COMPLETED
Major Depressive Disorder
New York State Psychiatric Institute
2012-09 PHASE4
NCT01870843 COMPLETED
Depressive Disorder, Major
Xian-Janssen Pharmaceutical Ltd.
2014-03 PHASE4
NCT01324700 COMPLETED
Depression; Asthma
University of Texas Southwestern Medical Center
2010-07 PHASE4
NCT01538693 COMPLETED
Spinal Cord Injury
T. George Hornby
2011-12
NCT00926835 TERMINATED
Major Depressive Disorder
Ministry of Health & Welfare, Korea
2009-05 PHASE4
NCT00754936 COMPLETED
Depression
Weill Medical College of Cornell University
2007-05
NCT00360399 COMPLETED
Depression
Emory University
2006-08
NCT01483053 UNKNOWN
Major Depressive Disorder (MDD)
Baker Heart and Diabetes Institute
2014-01 PHASE4
NCT02237937 UNKNOWN
Major Depression
HolsboerMaschmeyer NeuroChemie GmbH
2011-09 PHASE4
NCT01628783 UNKNOWN
Depression
Jesper Ekelund
2012-06 PHASE4
NCT01278498 UNKNOWN
Depression
Asan Medical Center
2011-01 PHASE4
NCT02072278 COMPLETED
Healthy Men
H. Lundbeck A/S
2014-02 PHASE1
NCT00660062 TERMINATED
Major Depression
Hillerod Hospital, Denmark
2009-08 PHASE4
NCT01103180 TERMINATED
Borderline Personality Disorder
University of Chicago
2010-09 PHASE2
NCT01764867 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
2012-06 PHASE4
NCT02175602 COMPLETED
Hepatitis C Infection
Bristol-Myers Squibb
2014-06 PHASE1
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
2013-04
NCT01251471 COMPLETED
Depression
Medical University of Vienna
2011-08 PHASE4
NCT01841125 COMPLETED
Alzheimer's Disease
Konkuk University Medical Center
2011-11 PHASE4
NCT00974155 COMPLETED
Depression
K. Lieb
2009-09 PHASE4
NCT01871701 COMPLETED
Healthy
Seoul National University Hospital
2012-11 PHASE1
NCT02122939 COMPLETED
Healthy
Seoul National University Hospital
2013-09 PHASE1
NCT01008098 UNKNOWN
Posttraumatic Stress Disorder
Seoul National University Hospital
2008-11 PHASE2
NCT00620789 UNKNOWN
Insomnia; Major Depressive Disorder
Toronto Metropolitan University
2008-03
NCT01364649 COMPLETED
Treatment Outcome
Takeda
2011-06 PHASE3
NCT01741142 TERMINATED
Major Depressive Disorder
AbbVie (prior sponsor, Abbott)
2012-01 PHASE2
NCT00248651 COMPLETED
Dyspepsia and Other Specified Disorders of Function of Stomach
Mayo Clinic
2006-10 PHASE2; PHASE3
NCT00517764 COMPLETED
Depression
Centre for Addiction and Mental Health
2006-12
NCT01271244 COMPLETED
PTSD
VA Nebraska Western Iowa Health Care System
2008-06 PHASE4
NCT00613470 COMPLETED
Depression
Mayo Clinic
2005-03 PHASE1
NCT01369095 COMPLETED
Depression
Bristol-Myers Squibb
2011-07 PHASE2
NCT01587326 UNKNOWN
Depression
Beitou Armed Forces Hospital, Taipei, Taiwan
2012-04
NCT01430520 COMPLETED
Postoperative Pain
Hvidovre University Hospital
2011-09 PHASE4
NCT01219686 TERMINATED
Unipolar Depression
Markus KOSEL
2010-10 PHASE2; PHASE3
NCT00149799 COMPLETED
Anxiety Disorders; Somatoform Disorders
Massachusetts General Hospital
2005-05 PHASE3
NCT02246244 COMPLETED
ENT Cancer
Gustave Roussy, Cancer Campus, Grand Paris
2009-04 PHASE3
NCT00419471 COMPLETED
Depressive Disorder; Coronary Disease
Chonnam National University Hospital
2007-05 PHASE4
NCT00732901 COMPLETED
Cocaine Dependence
Virginia Commonwealth University
2008-06 PHASE2; PHASE3
NCT00955474 TERMINATED
Major Depressive Disorder With Psychotic Features
Massachusetts General Hospital
2008-09 PHASE4
NCT01198795 COMPLETED
Major Depressive Disorder
Forest Laboratories
2010-09 PHASE4
NCT01363310 TERMINATED
Depression With Prominent Agitation
Physicians Research And Education Network
2010-10 PHASE3
NCT00707863 COMPLETED
Major Depression
Indiana University
2008-05 PHASE4
NCT00851006 COMPLETED
Major Depressive Disorder
University of Utah
2009-04 PHASE2
NCT01368432 COMPLETED
TBI; Major Depression; Other Psychiatric Disorders
Johns Hopkins University
2010-04 PHASE2
NCT00227292 WITHDRAWN
Low Back Pain; Depression
Martin-Luther-Universität Halle-Wittenberg
2007-11 PHASE4
NCT01082237 COMPLETED
Major Depressive Disorder
University of California, Los Angeles
2009-10 PHASE4
NCT01309776 COMPLETED
Major Depressive Disorder
Samsung Medical Center
2011-03 PHASE4
NCT01368068 TERMINATED
Perimenopausal Depression
The Alfred
2012-07 PHASE4
NCT00536172 COMPLETED
Depression
University of Nebraska
2007-12-01 PHASE4
NCT02480400 COMPLETED
Major Depressive Disorder
Abarbanel Mental Health Center
2010-06
NCT00953745 COMPLETED
Major Depressive Disorder
Washington University School of Medicine
2009-05
NCT00456014 COMPLETED
Depression
New York State Psychiatric Institute
2006-09
NCT00917059 COMPLETED
Depression
University of California, Los Angeles
2009-05 PHASE4
NCT01115699 TERMINATED
Depression
Mayo Clinic
2010-04
NCT01814085 COMPLETED
Major Depressive Disorder
Xian-Janssen Pharmaceutical Ltd.
2010-02 PHASE4
NCT00953108 COMPLETED
Major Depression
Ludwig-Maximilians - University of Munich
2009-09 PHASE3
NCT00693732 COMPLETED
Irritable Bowel Syndrome
National University Hospital, Singapore
2009-02 PHASE4
NCT00989053 UNKNOWN
Depression; Anxiety; In Vitro Fertilization
Tel-Aviv Sourasky Medical Center
2010-01
NCT01214044 COMPLETED
Depression
Oregon Health and Science University
2008-05
NCT00386893 WITHDRAWN
Depression
Ludwig-Maximilians - University of Munich
2006-10 PHASE4
NCT00574847 COMPLETED
Myocardial Ischemia
Duke University
2006-09 PHASE4
NCT00935246 UNKNOWN
Depression; Continuous Antidepressant Abuse; Adverse Reaction to Drug
Samsung Medical Center
2008-12
NCT01404871 COMPLETED
Obsessive Compulsive Disorder
Sunnybrook Health Sciences Centre
2009-04
NCT01111552 TERMINATED
Major Depressive Disorder (MDD)
Otsuka Pharmaceutical Development & Commercialization, Inc.
2010-07-29 PHASE3
NCT01123707 TERMINATED
Major Depressive Disorder (MDD)
Otsuka Pharmaceutical Development & Commercialization, Inc.
2010-11-18 PHASE3
NCT01111539 TERMINATED
Major Depressive Disorder (MDD)
Otsuka Pharmaceutical Development & Commercialization, Inc.
2010-07-13 PHASE3
NCT01111565 TERMINATED
Major Depressive Disorder (MDD)
Otsuka Pharmaceutical Development & Commercialization, Inc.
2010-10-04 PHASE3
NCT00702780 COMPLETED
Alzheimer's Disease
Seoul National University Hospital
2008-11
NCT01418274 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
2011-08 PHASE1
NCT01401595 COMPLETED
Night Eating Syndrome
University of Pennsylvania
2009-12 PHASE3
NCT00971815 COMPLETED
Insulin Resistance; Low Birth Weight; Type 2 Diabetes; Cardiovascular Disease; Melancholic Depression; Anxiety Disorders
University of Aarhus
2009-05
NCT00601965 COMPLETED
Generalized Anxiety Disorder
Veterans Medical Research Foundation
2007-10
NCT00404755 COMPLETED
Major Depressive Disorder; Dysthymia
New York State Psychiatric Institute
2006-07 PHASE4
NCT00367341 COMPLETED
Major Depressive Disorder
Emory University
2006-08
NCT00519428 COMPLETED
Major Depressive Disorder
New York State Psychiatric Institute
2007-08 PHASE4
NCT01601730 COMPLETED
Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Substance Abuse
Baylor College of Medicine
2010-08 PHASE1
NCT00703742 COMPLETED
Depression; Depression Secondary to Other Disease
Kunming Medical University
2008-06
NCT00220480 UNKNOWN
Depressive Disorder, Major
Sheba Medical Center
2005-02
NCT00488670 TERMINATED
Depressive Disorder
University of British Columbia
2010-12 PHASE3
NCT01398514 COMPLETED
Fear Conditioning
Massachusetts General Hospital
2008-10 PHASE4
NCT01045083 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
2010-01 PHASE1
NCT01814098 COMPLETED
Depressive Disorder, Major
Xian-Janssen Pharmaceutical Ltd.
2009-07-07 PHASE4
NCT00387348 TERMINATED
Colorectal Cancer; Depression; Esophageal Cancer; Extrahepatic Bile Duct Cancer; Fatigue; Gallbladder Cancer; Gastric Cancer; Liver Cancer; Lung Cancer; Pancreatic Cancer
Massachusetts General Hospital
2006-03 PHASE3
NCT00825825 COMPLETED
Antidepressant Activity in Healthy Volunteers
Michael Henry, MD
2007-05 PHASE4
NCT00872027 COMPLETED
Depression
University of Minnesota
2009-04 PHASE4
NCT00833469 COMPLETED
Postpartum Depression
Massachusetts General Hospital
2009-01 PHASE4
NCT00702598 COMPLETED
Major Depressive Disorder (MDD)
University of British Columbia
2008-06
NCT01101685 COMPLETED
Dysphoria
University of Oxford
2010-02 PHASE4
NCT00824044 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
2008-07 PHASE4
NCT01034995 COMPLETED
Major Depression
Sanofi
2010-02 PHASE2
NCT00243477 COMPLETED
Coronary Artery Disease
Hopital Jean Minjoz
2006-01 PHASE4
NCT01638689 COMPLETED
Healthy
Karolinska Institutet
2010-09 PHASE1
NCT00723060 COMPLETED
Obsessive Compulsive Disorder
Seoul National University Hospital
2008-09 PHASE4
NCT01078870 UNKNOWN
Schizophrenia
National Taiwan University Hospital
2010-02 PHASE4
NCT01541475 COMPLETED
Major Depressive Disorder
Ewha Womans University
2009-03 PHASE4
NCT00594269 COMPLETED
Dementia
Sykehuset Innlandet HF
2008-08 PHASE4
NCT00985504 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
2009-09 PHASE4
NCT01090700 COMPLETED
Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland
2010-05 PHASE1
NCT00708240 UNKNOWN
Obsessive Compulsive Disorder
University of Ottawa
2007-01 PHASE4
NCT00636649 COMPLETED
Night Eating Syndrome
Duke University
2008-10
NCT00754793 TERMINATED
Chronic Sinusitis; Facial Pain Disorder; Depression
University of Washington
2009-01 PHASE4
NCT00967408 UNKNOWN
Stroke
Azienda Ospedaliero Universitaria Maggiore della Carita
2009-07 PHASE4
NCT00708396 UNKNOWN
OCD; Schizophrenia
BeerYaakov Mental Health Center
2008-07 PHASE4
NCT00746239 TERMINATED
Panic Disorder; Insomnia
Milton S. Hershey Medical Center
2008-08
NCT00101452 COMPLETED
Depression
Maurizio Fava, MD
2005-04
NCT00070941 COMPLETED
Parkinson's Disease; Depression
NYU Langone Health
2003-07 PHASE2; PHASE3
NCT00894543 COMPLETED
Hot Flashes; Menopause; Vasomotor Symptoms
Fred Hutchinson Cancer Center
2009-07
NCT01745601 COMPLETED
Anxiety Disorders
GlaxoSmithKline
2010-05-04 PHASE1
NCT00352885 COMPLETED
Depression
Emory University
2006-10-06 PHASE4
NCT00918684 COMPLETED
Depression
Weill Medical College of Cornell University
2002-12 PHASE4
NCT00452543 COMPLETED
Major Depressive Disorder; Alcohol Abuse; Alcohol Dependence
Massachusetts General Hospital
2007-03 PHASE4
NCT00642694 TERMINATED
Major Depressive Disorder; Insomnia
University of Texas Southwestern Medical Center
2007-05 PHASE3
NCT01119638 COMPLETED
Agitation; Psychosis; Alzheimer's Disease
Abarbanel Mental Health Center
2008-04 PHASE4
NCT00613067 COMPLETED
Generalized Anxiety Disorder
Inje University
2007-12
NCT00837564 UNKNOWN
Chronic Depression
University Hospital Freiburg
2009-02 PHASE3
NCT01020799 COMPLETED
Major Depressive Disorder
AstraZeneca
2009-11 PHASE2
NCT01876823 COMPLETED
Mild Cognitive Impairment; Major Depressive Disorder; Alzheimer's Disease
New York State Psychiatric Institute
2006-04 PHASE2; PHASE3
NCT01395433 COMPLETED
Healthy
H. Lundbeck A/S
2010-01 PHASE1
NCT00621946 COMPLETED
Severe Asthma; Moderate or Severe Major Depressive Disorder
University of Texas Southwestern Medical Center
2008-03 PHASE4
NCT00736021 COMPLETED
Stress Disorders, Post Traumatic
Hadassah Medical Organization
2008-09
NCT00866593 COMPLETED
Depression
Shanghai Mental Health Center
2009-03 PHASE2; PHASE3
NCT00965497 COMPLETED
Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis
University of South Carolina
2009-07 PHASE3
NCT00086307 COMPLETED
Major Depression
National Institute of Mental Health (NIMH)
2004-06 PHASE2
NCT00822744 COMPLETED
Major Depressive Disorder
Sanofi
2008-12 PHASE2
NCT00810069 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
2008-11 PHASE4
NCT00272025 TERMINATED
Bipolar Depression
Queen's University
2006-10 PHASE1
NCT00785434 COMPLETED
Major Depressive Disorder
Community Pharmacology Services Ltd
2008-10 PHASE4
NCT00902226 COMPLETED
Social Anxiety Disorder
H. Lundbeck A/S
2009-03 PHASE4
NCT00807248 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
2008-11 PHASE2
NCT00902564 COMPLETED
Generalized Anxiety Disorder
H. Lundbeck A/S
2009-03 PHASE4
NCT00145132 COMPLETED
Depression
Ludwig-Maximilians - University of Munich
2005-06 PHASE4
NCT00595699 COMPLETED
Major Depression; Temporal Lobe Epilepsy
Conrad, Erich J., M.D.
2006-11 PHASE4
NCT00628914 UNKNOWN
Major Depressive Disorder; Insomnia
University of California, Los Angeles
2008-05 PHASE4
NCT00933894 COMPLETED
Hepatitis C
Tibotec BVBA
2009-09 PHASE1
NCT00523705 TERMINATED
PMS
University of Pennsylvania
2008-02 PHASE4
NCT00343070 COMPLETED
Major Depression
University Hospital, Ghent
2007-03 PHASE2
NCT00177671 COMPLETED
Depression; Dementia
University of Pittsburgh
2003-12 PHASE4
NCT00475878 COMPLETED
Opiate Dependence; Depression
Butler Hospital
2006-12 PHASE3
NCT00464711 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
2006-09 PHASE4
NCT00590863 COMPLETED
Major Depressive Disorder
National Institute of Mental Health (NIMH)
2008-03 PHASE4
NCT00887679 COMPLETED
Anxiety Disorders; HIV Infections
Duke University
2009-05 PHASE3
NCT00177294 COMPLETED
Depression
University of Pittsburgh
2004-04 PHASE4
NCT00183677 COMPLETED
Depression
Massachusetts General Hospital
2003-07 PHASE4
NCT00386841 COMPLETED
Healthy
University of Copenhagen
2007-04 PHASE4
NCT00200902 COMPLETED
Depression
University of California, Los Angeles
2005-08 PHASE4
NCT00209807 UNKNOWN
Major Depression; Pain; Abdominal Pain
Hospital Universitari Vall d'Hebron Research Institute
2005-09 PHASE4
NCT00650897 UNKNOWN
Major Depression; Diabetes Mellitus
Sheba Medical Center
2008-04 PHASE4
NCT01527474 COMPLETED
Postpartum Depression
BC Women's Hospital & Health Centre
2008-04
NCT00300313 COMPLETED
Post-traumatic Stress Disorder
Sheba Medical Center
2005-06
NCT01797380 TERMINATED
Depression; HIV
Duke University
2008-01 PHASE4
NCT00464191 TERMINATED
Bipolar Disorder
Nordfjord Psychiatric Centre
2006-04 PHASE4
NCT00813735 COMPLETED
Insomnia
Lehigh Center for Clinical Research
2006-09 PHASE4
NCT00668525 COMPLETED
Major Depressive Disorder
Forest Laboratories
2008-04 PHASE3
NCT00215137 COMPLETED
OCD
Duke University
2004-10 PHASE2
NCT00531622 COMPLETED
Major Depressive Disorder
Sanofi
2007-09 PHASE3
NCT00166114 COMPLETED
Major Depressive Disorder
Emory University
2002-02 PHASE4
NCT00140257 UNKNOWN
Depression
Bispebjerg Hospital
2004-11 PHASE4
NCT00566202 COMPLETED
Major Depressive Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2007-12 PHASE2
NCT00232700 COMPLETED
Major Depressive Disorder
Charite University, Berlin, Germany
2005-09
NCT00190333 COMPLETED
Pulmonary Hypertension
Assistance Publique - Hôpitaux de Paris
2005-06 PHASE3
NCT00361218 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
2005-10 PHASE3
NCT00656552 UNKNOWN
Premature Ejaculation
Cairo University
2008-05 EARLY_PHASE1
NCT00220701 COMPLETED
Dysthymic Disorder
St. Luke's-Roosevelt Hospital Center
2002-06 PHASE4
NCT00071643 COMPLETED
Depression; Cerebrovascular Accident
Robert G. Robinson
2002-09
NCT00598052 UNKNOWN
Marijuana Dependence
Tel-Aviv Sourasky Medical Center
2007-12
NCT00456937 COMPLETED
Schizophrenia
BeerYaakov Mental Health Center
2006-07 PHASE4
NCT00136318 COMPLETED
Depression
Charite University, Berlin, Germany
2004-01 PHASE3
NCT00692263 COMPLETED
Healthy
University of Southern Denmark
2008-02 PHASE4
NCT00219349 COMPLETED
Generalized Anxiety Disorder
New York State Psychiatric Institute
2005-01 PHASE4
NCT00133276 COMPLETED
Hepatitis C
Foundation for Liver Research
2005-08 PHASE2; PHASE3
NCT00295347 COMPLETED
Major Depression
Universitätsklinikum Hamburg-Eppendorf
2005-12
NCT01996475 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
PHASE1
NCT00209170 COMPLETED
Diabetes; Depression
Emory University
2004-05 PHASE4
NCT00177216 COMPLETED
Sleep Disorders
University of Pittsburgh
2002-02 PHASE4
NCT01996462 COMPLETED
Healthy
Torrent Pharmaceuticals Limited
PHASE1
NCT00417118 COMPLETED
Generalized Anxiety
Sanofi
2006-12 PHASE3
NCT00481325 COMPLETED
Generalized Anxiety Disorder
Bristol-Myers Squibb
2007-07 PHASE2; PHASE3
NCT00420004 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
2006-12 PHASE2
NCT00415142 COMPLETED
Depressive Disorder
Sanofi
2006-12 PHASE3
NCT00432614 COMPLETED
Major Depressive Disorder
Sanofi
2007-01 PHASE3
NCT00406640 COMPLETED
Depression; Depressive Disorder; Depressive Disorder, Major
Wyeth is now a wholly owned subsidiary of Pfizer
2006-12 PHASE3
NCT03927950 COMPLETED
Major Depression
University of Tartu
2007-01 PHASE4
NCT00105586 COMPLETED
Anxiety Disorders; Generalized Anxiety Disorder
University of Pittsburgh
2004-12 PHASE4
NCT00146900 COMPLETED
Post-traumatic Stress Disorder
Hadassah Medical Organization
2004-08
NCT00358631 COMPLETED
Depressive Disorder
Sanofi
2006-07 PHASE2
NCT00390650 COMPLETED
Anxiety
Sanofi
2006-10 PHASE3
NCT00397059 COMPLETED
Healthy
University of Southern Denmark
2006-12 PHASE4
NCT00166296 COMPLETED
Major Depressive Disorder; Hepatitis C, Chronic
Germans Trias i Pujol Hospital
2005-03 PHASE2
NCT00384436 COMPLETED
Major Depressive Disorder
Forest Laboratories
2006-10 PHASE4
NCT00073697 COMPLETED
Depression
University of Pittsburgh
2003-05 PHASE4
NCT00135421 COMPLETED
Major Depressive Disorder
Bristol-Myers Squibb
2005-11 PHASE1; PHASE2
NCT00456430 COMPLETED
Depression
Indiana University
2003-07 PHASE4
NCT00149825 COMPLETED
Major Depressive Disorder; Insomnia
Stanford University
2004-06 PHASE2
NCT00375843 COMPLETED
Depression
National Institute of Mental Health (NIMH)
2005-01 PHASE4
NCT00296179 COMPLETED
Insomnia
Sanofi
2006-02 PHASE4
NCT00296777 COMPLETED
Major Depression; Dysthymia
New York State Psychiatric Institute
2004-12 PHASE4
NCT00610506 COMPLETED
Atypical Depression
Duke University
2005-10 PHASE3
NCT00107120 COMPLETED
Major Depressive Disorder
Forest Laboratories
2005-03 PHASE3
NCT00194948 COMPLETED
Major Depression
Weill Medical College of Cornell University
2003-09
NCT00277108 COMPLETED
Postpartum Depression
University of Rochester
2004-02
NCT00252343 COMPLETED
Anxiety Disorder
Sanofi
2005-09 PHASE3
NCT00252356 COMPLETED
Major Depressive Disorder
Sanofi
2005-09 PHASE3
NCT00252330 COMPLETED
Major Depressive Disorder
Sanofi
2005-09 PHASE3
NCT00260624 COMPLETED
Alzheimer's Disease; Psychomotor Agitation
University of Rochester
2003-02 PHASE4
NCT00812994 COMPLETED
Depression
University of California, San Francisco
2003-01 PHASE4
NCT00361790 COMPLETED
Healthy
Otsuka Pharmaceutical Development & Commercialization, Inc.
2006-08 PHASE1
NCT00234312 COMPLETED
Depression; Dysthymia
Oregon Health and Science University
2005-09 PHASE4
NCT01148472 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
2005-09 PHASE4
NCT00108979 COMPLETED
Major Depressive Disorder
Forest Laboratories
2005-03 PHASE3
NCT00296712 COMPLETED
Major Depression; Dysthymia; Depression NOS
New York State Psychiatric Institute
2005-02 PHASE4
NCT00109044 COMPLETED
Major Depressive Disorder
Forest Laboratories
2005-03 PHASE3
NCT00206934 COMPLETED
Healthy Volunteers
University of Copenhagen
2005-03
NCT01024140 COMPLETED
Chronic Posttraumatic Stress Disorder
Northern California Institute of Research and Education
2003-02
NCT00648570 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2004-08 PHASE1
NCT00648661 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2004-09 PHASE1
NCT00051259 COMPLETED
Major Depressive Disorder (MDD)
GlaxoSmithKline
2003-01 PHASE3
NCT00051272 COMPLETED
Major Depressive Disorder (MDD)
GlaxoSmithKline
2003-01 PHASE3
NCT00231335 COMPLETED
Schizophrenia; Schizoaffective Disorder
Emory University
2006-03 PHASE4
NCT00151294 TERMINATED
Depression; Multiple Sclerosis
Weill Medical College of Cornell University
2004-11 PHASE4
NCT00156325 COMPLETED
Bipolar Disorders
The University of New South Wales
2004-02 PHASE2
NCT00222820 COMPLETED
Major Depression
University of Pittsburgh
2002-04 PHASE4
NCT00116532 COMPLETED
Obsessive Compulsive Disorder
Massachusetts General Hospital
2002-10 PHASE4
NCT00416221 COMPLETED
Depression
University of California, San Diego
2006-04
NCT00423969 TERMINATED
Depression
Indiana University
2003-11 PHASE4
NCT00070694 COMPLETED
Depressive Disorder
National Institute of Mental Health (NIMH)
2003-09 PHASE2
NCT00935675 UNKNOWN
Carcinomas
Gustave Roussy, Cancer Campus, Grand Paris
PHASE3
NCT00149071 COMPLETED
Major Depression
Hillerod Hospital, Denmark
2004-03
NCT01522092 WITHDRAWN
Anxiety; COPD
Hull University Teaching Hospitals NHS Trust
PHASE3
NCT00121069 COMPLETED
Phobic Disorders
Connor, Kathryn M., M.D.
2002-09 PHASE2; PHASE3
NCT00239954 UNKNOWN
Major Depressive Disorder
Pharmacology Research Institute
2005-03 PHASE3
NCT00305500 COMPLETED
Obsessive-Compulsive Disorder
Abarbanel Mental Health Center
2006-03 PHASE3
NCT00080158 COMPLETED
Depression; Suicide, Attempted
New York State Psychiatric Institute
2004-03 PHASE2; PHASE3
NCT00329446 COMPLETED
Generalized Anxiety Disorder
AstraZeneca
2006-04 PHASE3
NCT00351169 COMPLETED
Major Depressive Disorder
AstraZeneca
2006-05 PHASE3
NCT00115011 COMPLETED
Impulse Control Disorders
Massachusetts General Hospital
2002-09 PHASE4
NCT00296933 COMPLETED
Depression; Major Depressive Disorder
University Health Network, Toronto
2005-12 PHASE3
NCT00073411 COMPLETED
Depression
Eli Lilly and Company
2003-11 PHASE3
NCT00442481 UNKNOWN
Major Depressive Disorder
Sheba Medical Center
2007-02 PHASE4
NCT00130455 TERMINATED
Depression
Psychiatric Hospital, Hillerod
2006-04 PHASE4
NCT00368862 COMPLETED
Alcoholism; Depression
Finnish Institute for Health and Welfare
2005-12 PHASE4
NCT00162968 COMPLETED
Pain; Polyneuropathies
Odense University Hospital
2004-12 PHASE4
NCT00414323 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
2006-11 PHASE1
NCT00296790 COMPLETED
Insomnia
Sanofi
2006-02 PHASE4
NCT00433121 COMPLETED
Dementia
Sykehuset Innlandet HF
2006-09 PHASE4
NCT00229333 UNKNOWN
Depressive Syndrome
Sheba Medical Center
2004-12 PHASE4
NCT00215228 COMPLETED
Major Depressive Disorder
Duke University
2005-07 PHASE2; PHASE3
NCT00565422 COMPLETED
Internet Addiction
Icahn School of Medicine at Mount Sinai
2002-12 PHASE4
NCT00114374 TERMINATED
Anxiety Disorder
Massachusetts General Hospital
2005-06 PHASE3
NCT01561092 WITHDRAWN
Stroke
University of Aarhus
PHASE4
NCT00148447 COMPLETED
Schizophrenia
BeerYaakov Mental Health Center
2004-11 PHASE3
NCT00351910 COMPLETED
Major Depressive Disorder
AstraZeneca
2006-05 PHASE3
NCT00255554 UNKNOWN
Borderline Personality Disorder
Bronx VA Medical Center

(data from https://clinicaltrials.gov, updated on 2025-12-16)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Escitalopram selectively binds to the serotonin transporter with high affinity (Ki = 0.89 nM), effectively blocking the presynaptic reuptake of serotonin from the synaptic cleft. This blockade increases synaptic concentrations of serotonin and enhances central serotonergic signaling, thereby alleviating symptoms in patients with major depressive disorder and obsessive-compulsive 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.