Clinical Trials

Numerous clinical trials evaluate the therapeutic utility and safety profile of fluoxetine hydrochloride across Early Phase 1 through Phase 4 investigations. Sponsored by prominent academic medical centers, pharmaceutical companies, and governmental organizations—including Duke University, Eli Lilly and Company, and the National Institute on Drug Abuse—these studies evaluate conditions such as major depression, treatment-resistant depression, cognitive dysfunction, nocturnal enuresis, and recurrent brain tumors. Exhibiting varied recruitment statuses including completed, recruiting, terminated, and withdrawn, these trials demonstrate the drug's broad clinical applications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07007221 WITHDRAWN
Depression; Hiv
University of Minnesota
 2026-07-01 PHASE2
NCT00018057 RECRUITING
Anxiety Disorders; Major Depressive Disorder
National Institute of Mental Health (NIMH)
 2001-10-02 PHASE2
NCT05422612 SUSPENDED
Post Traumatic Stress Disorder
Global Coalition for Adaptive Research
 2023-11-02 PHASE2
NCT05948553 SUSPENDED
Post Traumatic Stress Disorder
Global Coalition for Adaptive Research
 2023-11-02 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
NCT07174947 RECRUITING
Hepatobiliary Malignancy; Fluoxetine; Anxiety Disorders; Depression Disorders
First Affiliated Hospital of Wenzhou Medical University
 2025-10-01 PHASE2
NCT07110831 NOT_YET_RECRUITING
Depression; HIV
University of Ibadan
 2025-08-14 PHASE4
NCT07456501 NOT_YET_RECRUITING
Depression in Adolescence; Antidepressant Activity in Healthy Volunteers; Healthy Adult Participants
University of Oxford
 2026-03
NCT06225011 RECRUITING
Colorectal Adenocarcinoma
Jonsson Comprehensive Cancer Center
 2025-03-20 PHASE1
NCT06506136 NOT_YET_RECRUITING
Refractory Constipation; Somatic Symptom Disorder (DSM-5); Functional Constipation (FC)
Zhifeng Zhao, PhD
 2026-09-01 PHASE2
NCT05976347 RECRUITING
Depression
Wake Forest University Health Sciences
 2025-06-25 PHASE4
NCT04899687 RECRUITING
Obsessive-Compulsive Disorder; Illness Anxiety Disorder; Body Dysmorphic Disorders; Somatic Symptom Disorder
Stanford University
 2022-01-20 PHASE2
NCT06860958 RECRUITING
Depressive Disorder, Major
Tanta University
 2025-03-01 PHASE3
NCT06046859 RECRUITING
Musculoskeletal Injury
University of Florida
 2024-03-01 PHASE4
NCT05041907 RECRUITING
COVID-19
University of Oxford
 2021-09-30 PHASE2
NCT07025590 RECRUITING
Cardiovascular Diseases (CVD); Depression Anxiety Disorder
Guangdong Provincial People's Hospital
 2025-04-22
NCT07424781 RECRUITING
Depression - Major Depressive Disorder; Irritability; Depression
University of Oxford
 2025-10-01
NCT05814640 RECRUITING
Depression; Sequestra
First Affiliated Hospital of Chongqing Medical University
 2023-02-20 PHASE1; PHASE2
NCT05634707 ACTIVE_NOT_RECRUITING
Primary Brain Tumor; Brain Tumor, Recurrent
Duke University
 2023-08-05 EARLY_PHASE1
NCT06796946 NOT_YET_RECRUITING
Deprescription; Antidepressants
University of Huelva
 2026-06 EARLY_PHASE1
NCT07239011 RECRUITING
Depression
Tanta University
 2025-11-01 PHASE1; PHASE2
NCT03228732 RECRUITING
Type 1 Diabetes Mellitus
University of Maryland, Baltimore
 2017-12-19 EARLY_PHASE1
NCT06898606 RECRUITING
Depressive Disorder
Federal University of Latin American Integration
 2024-09-05 PHASE1; PHASE2
NCT04131829 RECRUITING
Obsessive-Compulsive Disorder
Yale University
 2019-10-14 PHASE1; PHASE2
NCT05944926 ACTIVE_NOT_RECRUITING
Depression; Depressive Disorder
Harvard Medical School (HMS and HSDM)
 2024-03-18 PHASE3
NCT07417046 RECRUITING
Amblyopia; VEP
Minia University
 2024-12-01
NCT05431413 UNKNOWN
Depression
Nanfang Hospital, Southern Medical University
 2020-01-07 PHASE2
NCT07521358 COMPLETED
Major Depressive Disorder (MDD)
Hasanuddin University
 2025-07-01
NCT03826875 COMPLETED
Stroke Hemorrhagic; Depression
University of Washington
 2019-03-01 PHASE2
NCT01672255 COMPLETED
Type 1 Diabetes; Hypoglycemia Associated Autonomic Failure
University of Maryland, Baltimore
 2012-10 EARLY_PHASE1
NCT04760275 ACTIVE_NOT_RECRUITING
Anxiety Disorders
Children's Hospital Los Angeles
 2021-02-10 PHASE3
NCT04850222 COMPLETED
Musculoskeletal Injury
University of Florida
 2021-09-01 PHASE2
NCT07115472 COMPLETED
Superior Mesenteric Artery Syndrome; Somatic Symptom Disorder (DSM-5)
Xijing Hospital of Digestive Diseases
 2024-01-01
NCT06341127 COMPLETED
KCNC1 Related Disorder; Genetic Disease; Rare Diseases
Holland Bloorview Kids Rehabilitation Hospital
 2024-01-17
NCT05792540 COMPLETED
Depressive Disorder
Tanta University
 2023-06-06 PHASE2
NCT06750445 COMPLETED
Refractory Constipation
Zhifeng Zhao, PhD
 2020-01-01
NCT04727424 UNKNOWN
Covid19; SARS-Associated Coronavirus
Cardresearch
 2021-01-19 PHASE3
NCT03466346 COMPLETED
Depression, Unipolar; Posttraumatic Stress Disorder; Trauma
University of California, San Francisco
 2020-08-31
NCT06185361 UNKNOWN
Nocturnal Enuresis; Enuresis; Enuresis, Nocturnal
Fayoum University Hospital
 2022-12-01
NCT05458479 COMPLETED
Down Syndrome; Depression
Massachusetts General Hospital
 2022-12-05 PHASE4
NCT05127369 UNKNOWN
Depression
CAR-T (Shanghai) Biotechnology Co., Ltd.
 2022-01-01
NCT05789186 UNKNOWN
Depression
Chen Qian
 2023-05-01 EARLY_PHASE1
NCT05634707 Recruiting
Primary Brain Tumor|Brain Tumor Recurrent
Duke University
 2023-08-05 Early Phase 1
NCT05588102 COMPLETED
Geriatric Depression; Cognitive Impairment
Capital Medical University
 2021-05-18
NCT05361330 UNKNOWN
Outpatients / Inpatients With Depression
Peking University
 2022-05-30
NCT03390933 COMPLETED
Depression; Hemodialysis-Induced Symptom
MetroHealth Medical Center
 2018-03-01 PHASE4
NCT03779789 COMPLETED
Major Depressive Disorder
Azienda Ospedaliera Universitaria Integrata Verona
 2019-02-01 PHASE4
NCT04676139 UNKNOWN
Nocturnal Enuresis
Mansoura University
 2020-07-01 PHASE3
NCT03448159 COMPLETED
Stroke; Cerebrovascular Accident; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases
University Health Network, Toronto
 2019-01-01 PHASE2
NCT04780152 UNKNOWN
Major Depressive Disorder
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
 2021-10 PHASE2; PHASE3
NCT05283954 WITHDRAWN
SARS-CoV2 Infection; COVID-19
Oriol Mitja
 2022-05-01 PHASE2; PHASE3
NCT02357849 TERMINATED
Attenuated Psychosis Syndrome
Northwell Health
 2014-07 PHASE4
NCT02767999 COMPLETED
Stroke
University Hospital, Toulouse
 2017-02-27 PHASE4
NCT02709655 COMPLETED
Depressive Disorder, Major
H. Lundbeck A/S
 2016-05-18 PHASE3
NCT02427334 UNKNOWN
Premenstrual Syndrome
Cairo University
 2015-04 PHASE3
NCT04154813 UNKNOWN
Fluoxetine
Shanghai Mental Health Center
 2020-02-01
NCT05346445 COMPLETED
Postmenopause; Hot Flashes
Hospital Regional 1o de Octubre
 2021-01-20
NCT04570449 WITHDRAWN
Covid19
Milton S. Hershey Medical Center
 2020-11 EARLY_PHASE1
NCT04876521 COMPLETED
Post-Schizophrenic Depression
All India Institute of Medical Sciences, Bhubaneswar
 2019-10-14 PHASE4
NCT04377308 COMPLETED
COVID-19; Cytokine Storm
University of Toledo Health Science Campus
 2020-05-01 PHASE4
NCT03569475 COMPLETED
Major Depressive Disorder
Allergan
 2018-07-06 PHASE3
NCT05532332 COMPLETED
Healthy Subjects
Future University in Egypt
 2021-01-18 PHASE1
NCT03728153 COMPLETED
Acute Stroke; Stroke, Ischemic
Massachusetts General Hospital
 2019-11-26 PHASE2
NCT03455088 COMPLETED
Feeding and Eating Disorders
Shanghai Mental Health Center
 2018-06-13
NCT01963832 WITHDRAWN
Severe Stroke With Affected Arm Motor Function
University of Alabama at Birmingham
 2016-11 PHASE2
NCT01615055 WITHDRAWN
Cognitive Dysfunction
University of California, Los Angeles
 2018-06 EARLY_PHASE1
NCT02737930 TERMINATED
Acute Stroke; Visual Field Loss
Bogachan Sahin
 2016-05 PHASE2
NCT04676139 Unknown status
Nocturnal Enuresis
Mansoura University
 2020-07-01 Phase 3
NCT02683213 COMPLETED
Stroke
Karolinska Institutet
 2014-10-20 PHASE3
NCT02472613 COMPLETED
Post-stroke Depression
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
 2016-05
NCT03219008 UNKNOWN
Depressive Disorder
Shanghai Mental Health Center
 2017-08-01 PHASE4
NCT04272476 COMPLETED
Depressive Disorder, Major
Chengdu University of Traditional Chinese Medicine
 2014-01 PHASE2
NCT02473250 COMPLETED
Bipolar Disorder
New York State Psychiatric Institute
 2015-01 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
NCT02431806 COMPLETED
Major Depressive Disorder
Forest Laboratories
 2015-06-23 PHASE3
NCT02709746 COMPLETED
Depressive Disorder, Major
H. Lundbeck A/S
 2016-05 PHASE3
NCT02751632 COMPLETED
Psychotic Disorders; Personality Disorders; Clinical High Risk
Orygen
 2016-04 PHASE3
NCT02208466 COMPLETED
Stroke; Motor Function
Spaulding Rehabilitation Hospital
 2014-09 PHASE2
NCT03138681 UNKNOWN
Major Depressive Disorder
Zhujiang Hospital
 2017-05-03 PHASE2
NCT02929667 COMPLETED
Epilepsy; SUDEP
Rup Kamal Sainju
 2017-02-16 PHASE2
NCT02188225 UNKNOWN
Hot Flash; Quality of Life
Gonabad University of Medical Sciences
 2014-07
NCT03072264 COMPLETED
Generalized Anxiety Disorder
Hospital de Clinicas de Porto Alegre
 2016-10
NCT02601677 UNKNOWN
Obsessive Compulsive Disorder
Tang-Du Hospital
 2015-11
NCT02017535 COMPLETED
Adolescent Depression
University of Minnesota
 2012-06 PHASE1; PHASE2
NCT02372799 COMPLETED
Major Depressive Disorder
Forest Laboratories
 2015-02-28 PHASE3
NCT01910259 COMPLETED
Secondary Progressive Multiple Sclerosis
University College, London
 2014-12-18 PHASE2
NCT01615055 Withdrawn
Cognitive Dysfunction
University of California Los Angeles|City of Hope Medical Center
 2018-06 Early Phase 1
NCT02389712 TERMINATED
Bipolar Disorder
Mayo Clinic
 2015-03 PHASE4
NCT03051451 SUSPENDED
Overweight and Obesity
Laboratorios Silanes S.A. de C.V.
 PHASE2
NCT02238977 TERMINATED
Major Depression; End Stage Renal Disease
University of Arkansas
 2016-03-31 PHASE4
NCT03390933 Completed
Depression|Hemodialysis-Induced Symptom
MetroHealth Medical Center
 2018-03-01 Phase 4
NCT02593695 UNKNOWN
Anorexia Nervosa
Tang-Du Hospital
 2015-10
NCT02022709 COMPLETED
Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders
Shanghai Mental Health Center
 2014-01 PHASE4
NCT02562053 UNKNOWN
Premenstrual Syndrome
Cairo University
 2015-10 PHASE3
NCT02488538 UNKNOWN
Premenstrual Syndrome
Cairo University
 2015-07 PHASE3
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT03638908 COMPLETED
Pulmonary Arterial Hypertension
University of Texas Southwestern Medical Center
 2013-11 PHASE2
NCT01360866 COMPLETED
Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2011-10 PHASE3
NCT01824433 COMPLETED
Major Depression
Capital Medical University
 2013-03-07 PHASE4
NCT02916238 COMPLETED
Major Depression
Florida International University
 2014-02 PHASE4
NCT00961961 COMPLETED
Bipolar Disorder
University of Pennsylvania
 2009-07-01 PHASE4
NCT01802437 COMPLETED
Adolescent Depression
University of Minnesota
 2010-11 PHASE1; PHASE2
NCT01714310 COMPLETED
Severe Mood Dysregulation
University of California, Los Angeles
 2013-01 PHASE2
NCT01674868 WITHDRAWN
Stroke
Spaulding Rehabilitation Hospital
 2013-04
NCT03436173 COMPLETED
Depression
University of Oxford
 2012-05-23
NCT01687478 TERMINATED
Treatment Resistant Depression
Eli Lilly and Company
 2012-09 PHASE3
NCT02063425 TERMINATED
Cerebral Infarction
Centre Hospitalier St Anne
 2014-02
NCT00834834 COMPLETED
Borderline Personality Disorder; Suicide
New York State Psychiatric Institute
 2009-03 PHASE4
NCT01699490 UNKNOWN
Major Depressive Disorder
National Cheng-Kung University Hospital
 2012-08 PHASE4
NCT02593734 COMPLETED
Schizophrenia; Mood Disorders,; Anxiety Disorder
University of Ghana Medical School
 2013-07 PHASE4
NCT05378711 COMPLETED
Selective Mutism; Social Anxiety
Michigan State University
 2014-01-01 PHASE2
NCT01479920 COMPLETED
Major Depressive Disorder; Depression
The University of Hong Kong
 2012-06
NCT01372150 COMPLETED
Major Depressive Disorder
Pfizer
 2011-11-17 PHASE3
NCT01808651 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2013-05 PHASE3
NCT01764867 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
 2012-06 PHASE4
NCT01737541 TERMINATED
Intracerebral Hemorrhage; Motor Impairment
Universidad Autónoma de Aguascalientes
 2012-11 PHASE3
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
 2013-04
NCT01808612 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2013-03 PHASE3
NCT00806234 COMPLETED
Psychotic Disorders
Johns Hopkins University
 2009-01 PHASE4
NCT01740726 TERMINATED
Major Depressive Disorder
Emory University
 2013-01
NCT01635218 COMPLETED
Moderate Depression; Menopausal and Postmenopausal Disorders
Hospital Juarez de Mexico
 2012-03 PHASE2
NCT00958204 COMPLETED
Major Depressive Disorder (MDD)
University of British Columbia
 2009-10 PHASE3
NCT02965274 COMPLETED
Healthy Subjects
Torrent Pharmaceuticals Limited
 2013-11 PHASE1
NCT02965261 COMPLETED
Healthy Subjects
Torrent Pharmaceuticals Limited
 2013-11 PHASE1
NCT01967979 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2013-10 PHASE1
NCT01436643 TERMINATED
Depression; Relapsing-remitting Multiple Sclerosis
Novartis Pharmaceuticals
 2011-11 PHASE4
NCT00578669 COMPLETED
Major Depressive Disorder; Nicotine Dependence; Depression
Butler Hospital
 2008-04 PHASE3
NCT01148316 COMPLETED
Obsessive-Compulsive Disorder
Roseli Shavitt
 2010-08
NCT00531518 COMPLETED
Schizophrenia; Bipolar Disorder; Depression; Psychotic Disorders
MaineHealth
 2007-10
NCT00612313 COMPLETED
Depression
University of Texas Southwestern Medical Center
 2008-02
NCT01174394 COMPLETED
Depression; Stroke
The University of Hong Kong
 2010-05
NCT01545843 COMPLETED
Depression
University of Michigan
 2009-03 PHASE2
NCT00851006 COMPLETED
Major Depressive Disorder
University of Utah
 2009-04 PHASE2
NCT01254305 COMPLETED
Major Depressive Disorder
Forest Laboratories
 2011-04 PHASE2
NCT01361217 COMPLETED
Drug-Drug Interaction; Healthy Volunteers
University of Washington
 2011-09
NCT00633685 UNKNOWN
Posttraumatic Stress Disorder, Combat-related
TEMPVA Research Group, Inc.
 2010-03 PHASE4
NCT00245635 COMPLETED
Body Dysmorphic Disorder
Montefiore Medical Center
 2004-11 PHASE4
NCT00958568 COMPLETED
Treatment Resistant Depression
Eli Lilly and Company
 2009-08 PHASE3
NCT00844857 COMPLETED
Bipolar Depression
Eli Lilly and Company
 2009-04 PHASE4
NCT00986310 COMPLETED
Uncontrolled Partial Epilepsy; Ictal Hypoventilation
University of California, Davis
 2009-08
NCT01185977 COMPLETED
Major Depressive Disorder
University of California, Los Angeles
 2010-04 PHASE4
NCT01269788 COMPLETED
Non-erosive Reflux Disease
Tehran University of Medical Sciences
 2010-08 PHASE2; PHASE3
NCT00942708 COMPLETED
Pulmonary Arterial Hypertension
University of Texas Southwestern Medical Center
 2009-09 PHASE2
NCT01146548 COMPLETED
Multiple System Atrophy
University Hospital, Toulouse
 2008-05 PHASE2
NCT00296725 COMPLETED
Major Depression; Dysthymia; Depressive Disorder Not Otherwise Specified
New York State Psychiatric Institute
 1994-04 PHASE1; PHASE2
NCT00339079 COMPLETED
Hypochondriasis
Brigham and Women's Hospital
 2006-06 PHASE1; PHASE2
NCT00849901 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2009-03 PHASE3
NCT00849693 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2009-03 PHASE3
NCT00115804 COMPLETED
Juvenile Primary Fibromyalgia Syndrome (JPFS); Fibromyalgia
University of Cincinnati
 2005-06 PHASE3
NCT01243957 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2010-10 PHASE1
NCT00657163 COMPLETED
Ischemic Stroke; Motor Impairment
University Hospital, Toulouse
 2005-03 PHASE2
NCT00449007 TERMINATED
Depression; Alcoholism; Suicidal Behavior
New York State Psychiatric Institute
 2006-02 PHASE4
NCT02569970 COMPLETED
Epilepsy; Ictal/Post-ictal Hypoxemia
Hospices Civils de Lyon
 2010-11 PHASE3
NCT01204086 UNKNOWN
Major Depressive Disorder; Antidepressive Agents; Pharmacogenetics; Venlafaxine; Fluoxetine
National Cheng-Kung University Hospital
 2007-03 PHASE4
NCT00873834 WITHDRAWN
Autism
Assistance Publique - Hôpitaux de Paris
 2009-09 PHASE2
NCT00557427 TERMINATED
Depression
Rafa Laboratories
 2009-01 PHASE4
NCT00592852 TERMINATED
Pediatric Bipolar Disorder; Pediatric OCD
Massachusetts General Hospital
 2005-12 PHASE4
NCT00965562 COMPLETED
Premenstrual Syndrome
Donaghue Medical Research Foundation
 2000-09
NCT00466609 COMPLETED
Obsessive Compulsive Disorder
University of Sao Paulo
 2007-05 PHASE4
NCT01075529 COMPLETED
Major Depressive Disorder
Kaohsiung Kai-Suan Psychiatric Hospital
 2007-03 PHASE4
NCT01022632 COMPLETED
Major Depressive Disorder
Government Medical College, Bhavnagar
 2009-03
NCT00909155 COMPLETED
Major Depressive Disorder
University of Wisconsin, Madison
 2002-07
NCT00149643 COMPLETED
Depressive Disorder, Major; Cannabis Abuse
University of Pittsburgh
 2004-09 PHASE2
NCT00188942 COMPLETED
Major Depressive Disorder
University Health Network, Toronto
 2005-02 PHASE4
NCT00732290 COMPLETED
Healthy
Centre Hospitalier Universitaire de Saint Etienne
 2009-02 PHASE1
NCT00787111 TERMINATED
Autistic Disorder
Neuropharm
 2008-11 PHASE3
NCT00666757 COMPLETED
Depression
Eli Lilly and Company
 2008-05 PHASE4
NCT00676026 COMPLETED
Healthy
University of Pennsylvania
 2005-05
NCT00515320 COMPLETED
Autistic Disorder
Neuropharm
 2007-08 PHASE3
NCT00758966 TERMINATED
Obsessive-Compulsive Disorder
Orexigen Therapeutics, Inc
 2008-09 PHASE2
NCT00603018 COMPLETED
Anorexia Nervosa
University of Pittsburgh
 2007-06
NCT00678574 COMPLETED
Premenstrual Dysphoric Disorder; Premenstrual Syndrome
University of Pennsylvania
 1998-03 PHASE4
NCT00078754 COMPLETED
Intermittent Explosive Disorder
University of Chicago
 2003-05 PHASE2
NCT00247624 COMPLETED
Sleep Initiation and Maintenance Disorders; Depression
Wake Forest University Health Sciences
 2005-10 PHASE4
NCT00680602 COMPLETED
Obsessive Compulsive Disorder
University of Sao Paulo
 2006-01 PHASE4
NCT00573547 WITHDRAWN
Depression
Creighton University
 2007-02 PHASE4
NCT00118404 COMPLETED
Depression
University of Texas Southwestern Medical Center
 2000-03 PHASE3
NCT00626340 COMPLETED
Menopause; Depression
University of Pennsylvania
 1999-07 PHASE4
NCT00611975 COMPLETED
Healthy
Weill Medical College of Cornell University
 2005-10 PHASE4
NCT00183339 COMPLETED
Autistic Disorder
University of North Carolina, Chapel Hill
 2005-07 PHASE2
NCT00533117 COMPLETED
Borderline Personality Disorder
New York State Psychiatric Institute
 2001-03 PHASE4
NCT00208897 COMPLETED
Major Depressive Disorder
Emory University
 1997-12
NCT01119430 TERMINATED
Major Depression
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
 2004-05 PHASE2
NCT00027378 COMPLETED
Alcoholism; Depression
University of Pittsburgh
 2001-07 PHASE2
NCT00592670 COMPLETED
Type 1 Diabetes
Vanderbilt University
 2005-03
NCT00018902 COMPLETED
Depression
University of Pittsburgh
 2001-01 PHASE2; PHASE3
NCT00011765 COMPLETED
Domestic Violence
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2001-02-22 PHASE2
NCT00284791 TERMINATED
Adolescent Depression
MaineHealth
 2006-01
NCT00044616 COMPLETED
Bipolar Disorder; Depression
University of Pennsylvania
 2001-02 PHASE4
NCT00043537 COMPLETED
Social Phobia
University of Central Florida
 2001-04 PHASE3
NCT00061113 COMPLETED
Alcohol-Related Disorders; Marijuana Abuse; Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
 2001-02 PHASE4
NCT00338767 COMPLETED
HIV Infections; Depression
Massachusetts General Hospital
 2001-01 PHASE2
NCT00265291 COMPLETED
Major Depressive Disorder; Major Depression; Unipolar Depression
National Institute of General Medical Sciences (NIGMS)
 1999-11 PHASE2
NCT00649636 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2006-02 PHASE1
NCT01166087 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2006-02 PHASE1
NCT01166100 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2006-02 PHASE1
NCT00142779 COMPLETED
Cocaine-Related Disorders; Opioid-Related Disorders
National Institute on Drug Abuse (NIDA)
 2001-04
NCT00046020 COMPLETED
Depressive Disorder, Major; Recurrence
Wyeth is now a wholly owned subsidiary of Pfizer
 2000-08 PHASE4
NCT00108316 WITHDRAWN
Depression
US Department of Veterans Affairs
 2004-01
NCT00288574 COMPLETED
Anorexia Nervosa; Eating Disorders
New York State Psychiatric Institute
 2000-01 PHASE4
NCT00733525 COMPLETED
Eating Disorders
University of Minnesota
 2000-09
NCT00714779 COMPLETED
Major Depressive Disorder
University of Turku
 2000-01
NCT00018200 COMPLETED
Back Pain; Sciatica
US Department of Veterans Affairs
 1999-04 PHASE2
NCT00778024 COMPLETED
Healthy
Ranbaxy Laboratories Limited
 2003-08
NCT00005850 COMPLETED
Anxiety Disorder; Depression; Fatigue; Lung Cancer
Alliance for Clinical Trials in Oncology
 2001-08 PHASE2
NCT00000381 COMPLETED
Anxiety Disorders
University of Pittsburgh
 1997-06 PHASE3
NCT00000373 COMPLETED
Obsessive-Compulsive Disorder
University of Florida
 1992-09 PHASE4
NCT00018174 COMPLETED
Depression; Smoking
US Department of Veterans Affairs
 1998-02 PHASE3
NCT01247285 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2001-05 PHASE1
NCT01247272 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2001-05 PHASE1
NCT00947076 COMPLETED
Depression
Sandoz
 2001-02 PHASE1
NCT01360190 COMPLETED
Major Depressive Disorder
University of California, Los Angeles
 1994-08 PHASE4
NCT00913588 COMPLETED
Depression
Sandoz
 1996-05 PHASE1
NCT00913718 COMPLETED
Depression
Sandoz
 1996-06 PHASE1
NCT00000213 COMPLETED
Cocaine-Related Disorders
New York State Psychiatric Institute
 1990-04 PHASE2
NCT00004446 COMPLETED
Depersonalization Disorder
National Institute of Mental Health (NIMH)
 1998-04
NCT00000379 COMPLETED
Stress Disorders, Post-Traumatic
Boston University
 1999-01 PHASE3
NCT00004486 COMPLETED
Autism
Icahn School of Medicine at Mount Sinai
 1998-09
NCT00113737 COMPLETED
Cardiovascular Diseases; Heart Diseases
National Heart, Lung, and Blood Institute (NHLBI)
 1998-02
NCT00006204 COMPLETED
Alcoholism; Alcohol Dependence; Depression
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2000-03 PHASE4
NCT00027404 COMPLETED
Autistic Disorder
Icahn School of Medicine at Mount Sinai
 2001-09
NCT00227981 COMPLETED
Depression
University of Pittsburgh
 1995-03
NCT00427128 COMPLETED
Major Depression
New York State Psychiatric Institute
 1995-11 PHASE4
NCT00035321 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2002-04 PHASE3
NCT00005015 TERMINATED
Bipolar Disorder; Depression
National Institute of Mental Health (NIMH)
 PHASE3
NCT00009178 COMPLETED
Bulimia Nervosa
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 1998-03
NCT00080158 COMPLETED
Depression; Suicide, Attempted
New York State Psychiatric Institute
 2004-03 PHASE2; PHASE3
NCT00497562 COMPLETED
Fibromyalgia; Growth Hormone Deficiency
Centro Medico Teknon
 2004-05 PHASE2
NCT00332787 COMPLETED
Depression
University of Texas Southwestern Medical Center
 2000-06
NCT00191399 COMPLETED
Depression, Bipolar
Eli Lilly and Company
 2004-05 PHASE4
NCT00351910 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-05 PHASE3
NCT00006286 COMPLETED
Major Depressive Disorder; Depression
National Institute of Mental Health (NIMH)
 1998-09 PHASE3
NCT00485771 COMPLETED
Bipolar Disorder
Eli Lilly and Company
 2003-11 PHASE4
NCT00519051 COMPLETED
Depression
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
 2004-03

(data from https://clinicaltrials.gov, updated on 2026-07-10)

Check the Fluoxetine Hydrochloride (LY-110140) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluoxetine hydrochloride selectively binds to and inhibits the presynaptic serotonin transporter, blocking neuronal reuptake of serotonin and elevating extracellular 5-hydroxytryptamine levels in the synaptic cleft. This sustained enhancement of serotonergic signaling modulates downstream cell pathways, providing therapeutic efficacy in managing major depression, treatment-resistant depression, and other neurological conditions evaluated across clinical trials.

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.