Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate duloxetine for conditions including major depressive disorder, painful diabetic neuropathy, chronic low-back pain, chemotherapy-induced peripheral neuropathy, and chronic post-surgical pain. Sponsored by pharmaceutical companies such as Eli Lilly and Company and Takeda, alongside academic institutions like Thomas Jefferson University and the University of Michigan, these studies reflect diverse recruitment statuses encompassing completed protocols, active non-recruiting trials, and upcoming studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07649291 NOT_YET_RECRUITING
Knee Osteoarthritis; Pain; Depression
VA Office of Research and Development
 2027-03-01 PHASE2
NCT07731750 NOT_YET_RECRUITING
Chronic Low-back Pain
University of Michigan
 2026-07
NCT05851898 RECRUITING
Depression in Old Age; Fragility Fracture
Wake Forest University Health Sciences
 2024-04-08 PHASE4
NCT07203339 RECRUITING
Fibromyalgia (FM); tDCS; Duloxetine; BDNF; EEG
Hospital de Clinicas de Porto Alegre
 2025-09-30
NCT07759336 NOT_YET_RECRUITING
Knee Osteoarthritis (Knee OA); Chronic Pain; Chronic Knee Pain
Benedict Alter
 2026-08 PHASE4
NCT06614322 RECRUITING
Painful Peripheral Neuropathy; Diabetic Peripheral Neuropathic Pain (DPN); Chemotherapy Induced Peripheral Neuropathy (CIPN); Idiopathic Peripheral Neuropathy
University of Rochester
 2026-01-29 PHASE2
NCT06407401 NOT_YET_RECRUITING
ER+ Breast Cancer; HER2-negative Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Drug-Related Side Effects and Adverse Reactions; Musculoskeletal Pain
European Organisation for Research and Treatment of Cancer - EORTC
 2024-12 PHASE3
NCT06245109 RECRUITING
Knee Osteoarthritis
Northwestern University
 2024-02-26 PHASE4
NCT05840562 RECRUITING
Chemotherapy-induced Peripheral Neuropathy
Institut Cancerologie de l'Ouest
 2023-10-20 PHASE3
NCT06232473 RECRUITING
Functional Disorder
Aarhus University Hospital
 2024-01-01 PHASE4
NCT06423716 RECRUITING
Knee Osteoarthritis
Sunnybrook Health Sciences Centre
 2024-11-01 PHASE4
NCT06860984 RECRUITING
Biliary Disease
Tanta University
 2025-03-10 PHASE3
NCT07785544 NOT_YET_RECRUITING
Painful Diabetic Peripheral Neuropathy
Bangladesh Medical University
 2026-08-25
NCT05851976 RECRUITING
Back Pain, Low
Montefiore Medical Center
 2023-10-04 PHASE4
NCT05976347 RECRUITING
Depression
Wake Forest University Health Sciences
 2025-06-25 PHASE4
NCT07400471 RECRUITING
Post Endodontic Pain; Mechanical Detection Threshold; Mechanical Pain Threshold; Mechanical Pain Sensitivity
Chattogram International Dental College
 2026-02-06 EARLY_PHASE1
NCT06914557 RECRUITING
CIPN - Chemotherapy-Induced Peripheral Neuropathy; Pain
Fox Chase Cancer Center
 2025-03-03 PHASE2
NCT07431606 RECRUITING
Inflammatory Bowel Diseases
University of Pennsylvania
 2026-05-01 PHASE2
NCT07800468 NOT_YET_RECRUITING
Painful Diabetic Neuropathy (PDN); Diabetic Neuropathies; Type 2 Diabetes
Wah Medical college , POF hospital
 2026-12-01 PHASE4
NCT07421427 RECRUITING
Amantadine; Duloxetine; Pregabalin; Mastectomy; Pain Syndrome
Cairo University
 2026-02-21
NCT05814640 RECRUITING
Depression; Sequestra
First Affiliated Hospital of Chongqing Medical University
 2023-02-20 PHASE1; PHASE2
NCT04560673 ACTIVE_NOT_RECRUITING
Chemotherapy-Induced Peripheral Neuropathy; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
M.D. Anderson Cancer Center
 2020-07-10 PHASE2
NCT07025590 RECRUITING
Cardiovascular Diseases (CVD); Depression Anxiety Disorder
Guangdong Provincial People's Hospital
 2025-04-22
NCT07326163 ENROLLING_BY_INVITATION
Fibromyalgia; Aromatherapy; Cost
Bilecik Seyh Edebali Universitesi
 2026-03-01
NCT06807866 RECRUITING
THA
University of Miami
 2025-03-01 PHASE4
NCT05110144 RECRUITING
Refractory Chronic Cough
Mayo Clinic
 2021-11-01 PHASE2
NCT05120934 RECRUITING
Interstitial Lung Disease
Mayo Clinic
 2021-11-01 PHASE2
NCT07593313 RECRUITING
Central Post-Stroke Pain
Nanchong Central Hospital
 2024-01-01
NCT05949229 NOT_YET_RECRUITING
Post Operative Delirium
Amira Hassan Ahmed Ali
 2023-08 PHASE1; PHASE2
NCT07645482 NOT_YET_RECRUITING
Peripheral Neuropathy With Type 2 Diabetes
Beni-Suef University
 2026-07
NCT06606067 ACTIVE_NOT_RECRUITING
Chronic Post-surgical Pain
Parc de Salut Mar
 2024-09-03 PHASE3
NCT06711978 COMPLETED
CIPN; CIPN - Chemotherapy-Induced Peripheral Neuropathy; CIPN in Adjuvant Breast Cancer Patients; Duloxetine; Mirogabalin
Pusan National University Yangsan Hospital
 2024-12-01
NCT06896994 RECRUITING
Postherpetic Neuralgia
Beijing Tiantan Hospital
 2025-04-01
NCT06968624 NOT_YET_RECRUITING
Depression Disorders; Herpetic Neuralgia
Huazhong University of Science and Technology
 2025-06-15 PHASE4
NCT05786599 RECRUITING
Chemotherapy-induced Peripheral Neuropathy
University of British Columbia
 2025-03-21 PHASE2; PHASE3
NCT04137107 ACTIVE_NOT_RECRUITING
Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8
Alliance for Clinical Trials in Oncology
 2020-06-17 PHASE2; PHASE3
NCT06965569 COMPLETED
Treatment Resistant Depression
Alar Pharmaceuticals Inc.
 2025-04-21 PHASE1
NCT06551051 RECRUITING
Solid Tumour
Fudan University
 2024-08-06 PHASE2
NCT04862845 COMPLETED
Postoperative Pain
Cairo University
 2021-07-30 PHASE1
NCT05311774 COMPLETED
Cancer Pain
Assiut University
 2022-04-01
NCT06301061 UNKNOWN
Pain, Chronic; Lumbosacral Radiculopathy; Radicular; Neuropathic
Federico II University
 2024-04-01
NCT05065671 COMPLETED
Microbial Colonization
Rutgers, The State University of New Jersey
 2022-02-01 PHASE1
NCT04111627 COMPLETED
Knee Osteoarthritis; Depression
University of Maryland, Baltimore
 2021-10-07 PHASE2
NCT06842992 COMPLETED
Major Depressive Disorder (MDD)
Jiangsu Nhwa Pharmaceutical Co., Ltd.
 2024-12-04 PHASE2
NCT04245748 UNKNOWN
Anxious Depression; Depression
University of Cincinnati
 2020-03-01 PHASE4
NCT04970121 RECRUITING
Chemotherapy-induced Peripheral Neuropathy; Pain; Solid Tumor
Yan Yang, MD, Ph.D
 2021-08-21 PHASE2
NCT07439536 COMPLETED
Liver Cirrhosis With Diabetes
Kafrelsheikh University
 2024-07-01 PHASE4
NCT04245436 UNKNOWN
Anxiety; Depressive Symptoms
University of Cincinnati
 2020-01-01 PHASE4
NCT07253207 COMPLETED
Major Depressive Disorder (MDD)
Zhejiang Huahai Pharmaceutical Co., Ltd.
 2024-10-17 PHASE3
NCT05086393 COMPLETED
Pain, Postoperative; Total Knee Arthroplasty
Rush University Medical Center
 2021-11-01 PHASE4
NCT04504812 COMPLETED
Knee Osteoarthritis
Johns Hopkins University
 2021-02-01 PHASE3
NCT06087211 COMPLETED
Duloxetine; Magnesium Sulphate; Post-mastectomy Pain Syndrome
National Cancer Institute, Egypt
 2023-10-10
NCT05560516 UNKNOWN
Qutenza; Duloxetine; Chemotherapy-induced Peripheral Neuropathy; CIPN - Chemotherapy-Induced Peripheral Neuropathy
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2022-12-01
NCT05677295 UNKNOWN
Women With Stress Urinary Incontinence
Far Eastern Memorial Hospital
 2023-04-18 PHASE3
NCT06429605 COMPLETED
Vaginal Hysterectomy; Postoperative Pain; vNOTES
Erzincan Military Hospital
 2024-05-20
NCT06259526 COMPLETED
Depression
Tasly Pharmaceutical Group Co., Ltd
 2023-12-26 PHASE2
NCT05508516 COMPLETED
Fibromyalgia
China-Japan Friendship Hospital
 2022-09-01 EARLY_PHASE1
NCT04870957 COMPLETED
Chronic Low-back Pain
University of Michigan
 2021-06-09 PHASE4
NCT06091553 UNKNOWN
Neuropathy in Cacer Patien
Beni-Suef University
 2023-10-10 PHASE2
NCT05510856 COMPLETED
Oncology
Tanta University
 2022-09-01 PHASE4
NCT05396014 COMPLETED
Chronic Low-back Pain
University of North Carolina, Chapel Hill
 2022-09-12 PHASE4
NCT04395001 COMPLETED
Chronic Pain
Wake Forest University Health Sciences
 2021-02-24 PHASE4
NCT05256342 COMPLETED
Knee, Osteoarthritis (OA); Biomarkers for Prediction of OA Treatment Efficacy
Rambam Health Care Campus
 2021-12-30
NCT05611749 TERMINATED
Acute Post-operative Pain; Chronic Post Operative Pain; Narcotic Use; Opioid Use; Opioid Addiction
Scripps Health
 2023-05-30 PHASE2
NCT03548454 COMPLETED
Chronic Pain
Stanford University
 2018-09-20 PHASE4
NCT04639011 WITHDRAWN
Tibial Plateau Fracture; Pain, Postoperative
Boston Medical Center
 2022-10 PHASE4
NCT06025474 UNKNOWN
Burning Mouth Syndrome
Federico II University
 2023-01-01 PHASE3
NCT04388189 WITHDRAWN
Major Depressive Disorder
Alto Neuroscience
 2020-10-15 PHASE4
NCT04313335 COMPLETED
Postherpetic Neuralgia
Beijing Tiantan Hospital
 2021-03-01
NCT05254652 UNKNOWN
Osteoarthritis
The Catholic University of Korea
 2022-05
NCT03068247 WITHDRAWN
Major Depressive Disorder
University of Utah
 2021-11 PHASE3
NCT03575403 COMPLETED
Alcohol Use Disorder
Craig Rush
 2018-09-01 PHASE1
NCT05442268 UNKNOWN
Modified Radical Mastectomy; Postoperative Analgesia
Tanta University
 2022-07-16
NCT05711810 COMPLETED
Severe Acute Respiratory Syndrome-related Coronavirus; Renal Dialysis; Vaccines; Myocarditis Allergic; Infection Viral
Yang I. Pachankis
 2023-01-02 PHASE4
NCT04847245 UNKNOWN
Chronic Visceral Pain; Major Depressive Disorder
Peking University
 2021-05-01
NCT03623711 UNKNOWN
Major Depressive Disorder; Depression, Unipolar
Yuqi Cheng
 2018-08-01 EARLY_PHASE1
NCT05486026 COMPLETED
Osteo Arthritis Knee
Hawler Medical University
 2022-08-20 PHASE2
NCT05292066 UNKNOWN
Diabetic Peripheral Neuropathic Pain
Aga Khan University
 2022-10 EARLY_PHASE1
NCT04719585 UNKNOWN
Total Knee Arthroplasty; Osteoarthritis, Knee
The Catholic University of Korea
 2021-01
NCT05018013 UNKNOWN
Major Depressive Disorder (MDD)
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2021-08-21 PHASE2
NCT06837012 COMPLETED
Osteoarthritis of Knee; Central Sensitization; Central Sensitisation
Orthopaedic Arthroscopy Knee and Shoulder Clinic
 2021-01-01 PHASE4
NCT04732455 COMPLETED
Peripheral Neuropathy; Chemotherapy-induced Peripheral Neuropathy; Breast Cancer
Gamal Mohamed Taha Abouelmagd
 2021-01-15
NCT05937711 COMPLETED
Fibromyalgia
Ilker Fatih Sari
 2020-11-02
NCT05115123 COMPLETED
Pain, Postoperative
Mansoura University
 2022-03-02 PHASE2
NCT03249558 COMPLETED
Chronic Low Back Pain; Chronic Neck Pain
Massachusetts General Hospital
 2018-03-12 PHASE4
NCT03148522 UNKNOWN
Diagnosis and Treatment of Depression
Peking University
 2017-06-01
NCT04246619 TERMINATED
Painful Diabetic Peripheral Neuropathy
KRKA
 2019-11-12 PHASE4
NCT05296759 COMPLETED
Diabetic Neuropathies
Alexandria University
 2021-02-01 PHASE4
NCT04476030 COMPLETED
Depressive Disorder, Major
Biogen
 2020-11-09 PHASE3
NCT04364997 COMPLETED
Major Depressive Disorder
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2020-06-18 PHASE3
NCT04782310 UNKNOWN
Postoperative Pain
Cairo University
 2021-03-10 PHASE4
NCT05050656 COMPLETED
Anesthesia
Ain Shams University
 2021-03-15 PHASE4
NCT03852160 WITHDRAWN
Depressive Disorder, Treatment-Resistant
Janssen-Cilag International NV
 2019-12-01 PHASE3
NCT04224584 COMPLETED
Osteoarthritis, Knee
Kristian Kjær Petersen
 2020-01-01 PHASE2
NCT04117893 COMPLETED
Osteoarthritis, Knee; Chronic Pain
Beijing Tiantan Hospital
 2019-10-01 PHASE4
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
NCT04178993 COMPLETED
Methamphetamine Use Disorder
Craig Rush
 2019-09-01 PHASE1
NCT03434041 COMPLETED
Depressive Disorder, Treatment-Resistant
Janssen Research & Development, LLC
 2018-05-25 PHASE3
NCT04294953 UNKNOWN
Colorectal Cancer
Assiut University
 2020-03-01 PHASE2
NCT04727502 UNKNOWN
Drug Effect
National Cancer Institute, Egypt
 2020-12-20 PHASE2
NCT04751318 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
 2021-02-27 PHASE1
NCT04723238 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
 2021-01-23 PHASE1
NCT03812523 UNKNOWN
Chemotherapy-Induced Peripheral Neuropathy
Southeastern Regional Medical Center
 2019-06 PHASE2
NCT03271151 COMPLETED
Joint Disease; Pain, Acute; Pain, Chronic
Hospital for Special Surgery, New York
 2017-09-28 PHASE4
NCT03276689 COMPLETED
Neuropathic Pain
Rambam Health Care Campus
 2017-10-19
NCT04532684 COMPLETED
Knee Osteoarthritis
Fatih Sultan Mehmet Training and Research Hospital
 2016-10 PHASE4
NCT03395353 TERMINATED
Depressive Disorder
Shionogi
 2018-01-29 PHASE3
NCT03729284 WITHDRAWN
Healthy
Pfizer
 2020-03-30 PHASE4
NCT03794154 WITHDRAWN
Healthy
Pfizer
 2020-03-30 PHASE4
NCT04412876 WITHDRAWN
Stress Urinary Incontinence
Far Eastern Memorial Hospital
 2020-05-31 PHASE3
NCT03880916 UNKNOWN
Osteoarthritis, Knee
The Catholic University of Korea
 2019-03-30
NCT03560427 COMPLETED
Acute Pain
Assiut University
 2018-09-10
NCT03487211 COMPLETED
Fibromyalgia
Shaheed Zulfiqar Ali Bhutto Medical University
 2018-04-09 PHASE2; PHASE3
NCT03468348 COMPLETED
Acute Pain
Assiut University
 2018-04-01
NCT04140253 COMPLETED
Stress Urinary Incontinence in Women
Comenius University
 2019-02-01
NCT03618225 COMPLETED
Post-thoracotomy Pain
Assiut University
 2018-08-15 PHASE4
NCT02711215 UNKNOWN
Major Depressive Disorder
Medical University of Vienna
 2015-05 PHASE4
NCT03249311 UNKNOWN
None (i.e. Healthy Volunteers)
University of Ottawa
 2018-03-02 PHASE4
NCT03549026 UNKNOWN
Acute Pain
Assiut University
 2018-01-05
NCT03037073 COMPLETED
Postoperative Myalgia
Assiut University
 2017-04-15 PHASE2; PHASE3
NCT03315793 COMPLETED
Depressive Disorder
Shionogi
 2017-12-04 PHASE3
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
NCT03792828 UNKNOWN
Knee Osteoarthritis
Seoul National University Hospital
 2019-01 PHASE4
NCT01846182 TERMINATED
Gulf War Illness
VA Office of Research and Development
 2015-06-24 PHASE2
NCT02869035 COMPLETED
Major Depressive Disorder
Rigshospitalet, Denmark
 2016-08 PHASE1
NCT01912612 COMPLETED
Pain
University of Michigan Rogel Cancer Center
 2013-10-30 PHASE2
NCT03519022 COMPLETED
Cocaine Use Disorder
Craig Rush
 2018-06-01 EARLY_PHASE1
NCT03315533 COMPLETED
Musculoskeletal Pain
Rhode Island Hospital
 2018-01-19 PHASE2
NCT03054220 COMPLETED
Healthy
Jules Desmeules
 2016-07
NCT03249168 COMPLETED
Post Laparoscopic Shoulder Pain
Assiut University
 2017-10-01 PHASE3
NCT03038867 COMPLETED
Infertility, Male; Depression
Weill Medical College of Cornell University
 2016-12-12 PHASE2
NCT02700711 COMPLETED
Cocaine Use Disorder
University of Kentucky
 2016-02 PHASE1
NCT03364075 TERMINATED
Low Back Pain
Mark Ware
 2017-09-01 PHASE2
NCT03350334 COMPLETED
Laparoscopic Hysterectomy; Postoperative Recovery; Postoperative Pain
Acibadem University
 2017-12-04
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
NCT02857244 WITHDRAWN
Parkinson's Disease
University of Chicago
 2016-11 PHASE2
NCT02497287 COMPLETED
Treatment-resistant Depression
Janssen Research & Development, LLC
 2015-09-30 PHASE3
NCT02260388 COMPLETED
Cryptogenic Sensory Polyneuropathy
University of Kansas Medical Center
 2014-10 PHASE4
NCT02351440 WITHDRAWN
Quality of Recovery; Gynecologic Surgery; Laparoscopy
Northwestern University
 2016-04 PHASE4
NCT02422186 COMPLETED
Depressive Disorder, Treatment-Resistant
Janssen Research & Development, LLC
 2015-08-20 PHASE3
NCT02590874 COMPLETED
Mild Cognitive Impairment; Depression
University of North Texas Health Science Center
 2016-01 PHASE4
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02846701 COMPLETED
Neuropathic Pain
University Hospital, Strasbourg, France
 2016-11-17 PHASE4
NCT02418585 COMPLETED
Treatment-resistant Depression
Janssen Research & Development, LLC
 2015-08-07 PHASE3
NCT03110172 UNKNOWN
Osteoarthritis Of Knee
Dalian Municipal Central Hospital
 2017-01 PHASE1; PHASE2
NCT01237587 COMPLETED
Fibromyalgia
Eli Lilly and Company
 2011-03 PHASE3
NCT02417935 COMPLETED
Diabetic Peripheral Neuropathic Pain
Eli Lilly and Company
 2015-04 PHASE4
NCT02672202 TERMINATED
Post-operative Chronic Pain
Rambam Health Care Campus
 2016-02
NCT01360866 COMPLETED
Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2011-10 PHASE3
NCT02367404 UNKNOWN
Prostate Cancer; Urinary Incontinence
Institut Mutualiste Montsouris
 2015-05 PHASE3
NCT01598298 COMPLETED
Breast Cancer; Musculoskeletal Complications; Pain
SWOG Cancer Research Network
 2013-05-15 PHASE3
NCT02307305 UNKNOWN
Neuropathic Pain
Hanyang University Seoul Hospital
 2014-08 PHASE2
NCT02600247 UNKNOWN
Osteoarthritis
The Catholic University of Korea
 2015-11
NCT03121573 COMPLETED
Major Depressive Disorder
Taichung Veterans General Hospital
 2014-12-15
NCT02208778 COMPLETED
Osteoarthritis; Chronic Pain
University of Nottingham
 2014-12 PHASE4
NCT02612233 COMPLETED
Hand Osteoarthritis
St George's, University of London
 2013-09 PHASE4
NCT02335346 COMPLETED
Osteoarthritis of the Knee
Eli Lilly and Company
 2015-01 PHASE3
NCT03250494 COMPLETED
Post Operative Pain Control
Ain Shams University
 2014-12 PHASE4
NCT01504178 COMPLETED
Parkinson's Disease
University Hospital, Toulouse
 2011-05 PHASE3
NCT01451606 TERMINATED
Pelvis Pain Chronic
University of Maryland, Baltimore
 2011-07-11 PHASE4
NCT02443194 TERMINATED
Depression
michal roll
 2015-05 PHASE3
NCT02535000 COMPLETED
Intervertebral Disc Degeneration
Serviço de Anestesiologia de Joinville
 2014-01-01 PHASE4
NCT01127490 COMPLETED
Fibromyalgia
Albany Medical College
 2010-05-05
NCT02248480 COMPLETED
Osteoarthritis of the Knee
Eli Lilly and Company
 2014-10 PHASE3
NCT01688570 COMPLETED
Stroke
Medical College of Wisconsin
 2011-08 EARLY_PHASE1
NCT02005601 COMPLETED
Total Knee Arthroplasty
Hospital for Special Surgery, New York
 2013-11 PHASE4
NCT00360399 COMPLETED
Depression
Emory University
 2006-08
NCT01931475 COMPLETED
Osteoarthritis
Eli Lilly and Company
 2013-09 PHASE3
NCT02020122 COMPLETED
Pain
Rambam Health Care Campus
 2014-01
NCT01619566 WITHDRAWN
Fibromyalgia
University of California, San Diego
 2012-06 PHASE4
NCT01914666 COMPLETED
Back Pain Lower Back Chronic
Eli Lilly and Company
 2013-09 PHASE3
NCT01754493 COMPLETED
Major Depression; Irritable Bowel Syndrome
New York State Psychiatric Institute
 2008-12 PHASE4
NCT00929344 COMPLETED
Alcohol Dependence
The Scripps Research Institute
 2009-07 PHASE2
NCT01764867 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
 2012-06 PHASE4
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
 2013-04
NCT01650740 TERMINATED
Major Depressive Disorder
Sunnybrook Health Sciences Centre
 2012-08
NCT01855919 COMPLETED
Back Pain Lower Back Chronic
Eli Lilly and Company
 2013-05 PHASE3
NCT01470339 COMPLETED
Pain
Rambam Health Care Campus
 2011-12
NCT01166048 COMPLETED
Chronic Low Back Pain
Medical University of Vienna
 2010-05 PHASE4
NCT01558700 COMPLETED
Osteoarthritis
Northwestern University
 2012-03 PHASE4
NCT02174822 COMPLETED
Drug-drug Interaction
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2014-01 PHASE1
NCT01621191 COMPLETED
Fibromyalgia
Eli Lilly and Company
 2012-06 PHASE3
NCT01564862 COMPLETED
Depressive Disorder, Major
Takeda
 2012-04 PHASE2
NCT01359514 COMPLETED
Pain
Rambam Health Care Campus
 2008-04
NCT00464698 COMPLETED
Obsessive Compulsive Disorder
Massachusetts General Hospital
 2005-12 PHASE4
NCT01552057 COMPLETED
Fibromyalgia
Eli Lilly and Company
 2012-03 PHASE3
NCT01391221 UNKNOWN
Major Depression
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
 2011-07 PHASE4
NCT01179672 COMPLETED
Diabetic Neuropathy, Painful
Eli Lilly and Company
 2011-04 PHASE3
NCT01369095 COMPLETED
Depression
Bristol-Myers Squibb
 2011-07 PHASE2
NCT00619983 TERMINATED
Diabetic Neuropathic Pain; Chronic Low Back Pain
Wake Forest University
 2008-02 PHASE4
NCT01051466 COMPLETED
Major Depressive Disorder; Healthy Participants
Eli Lilly and Company
 2010-01 PHASE4
NCT01226511 COMPLETED
Anxiety Neuroses; Anxiety States, Neurotic; Neuroses, Anxiety
Eli Lilly and Company
 2011-06 PHASE3
NCT01268631 UNKNOWN
Fibromyalgia
Tel-Aviv Sourasky Medical Center
 2011-01
NCT01309945 COMPLETED
Depression
Bristol-Myers Squibb
 2011-04 PHASE2
NCT01116531 WITHDRAWN
Diabetic Polyneuropathy; Postherpetic Neuralgia
Turku University Hospital
 2010-04 PHASE4
NCT00617045 WITHDRAWN
Postpartum Depression; Major Depressive Disorder
Yale University
 2007-07
NCT00443352 COMPLETED
Migraine
Thomas Jefferson University
 2007-08 PHASE4
NCT00989157 COMPLETED
Bariatric Surgery
Neuropsychiatric Research Institute, Fargo, North Dakota
 2009-09 PHASE3
NCT01363284 COMPLETED
Diabetes; Painful Neuropathy
Rambam Health Care Campus
 2010-06
NCT00457730 COMPLETED
Multiple Sclerosis
Brown, Theodore R., M.D., MPH
 2007-01 PHASE2; PHASE3
NCT01288079 TERMINATED
Major Depressive Disorder
AstraZeneca
 2011-02 PHASE2
NCT01118780 COMPLETED
Generalized Anxiety Disorder
Eli Lilly and Company
 2010-10 PHASE4
NCT00375973 COMPLETED
Fatigue Syndrome, Chronic
University of Cincinnati
 2006-09 PHASE2; PHASE3
NCT01269866 COMPLETED
Systemic Lupus Erythematosus
Dr. Jesus Gutierrez Stone
 2010-12
NCT01579279 TERMINATED
Diabetic Neuropathic Pain
AbbVie (prior sponsor, Abbott)
 2012-04 PHASE2
NCT00660751 COMPLETED
Healthy
Rambam Health Care Campus
 2007-08
NCT01153009 COMPLETED
Depressive Disorder, Major
Takeda
 2010-06 PHASE3
NCT00471315 COMPLETED
Sphincter of Oddi Dysfunction
Medical University of South Carolina
 2006-07 PHASE3
NCT00889369 UNKNOWN
Major Depressive Disorder
Hamilton Health Sciences Corporation
 2009-05 PHASE4
NCT00489411 COMPLETED
Neurotoxicity; Pain; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific
Alliance for Clinical Trials in Oncology
 2008-04 PHASE3
NCT01443520 COMPLETED
Healthy
Turku University Hospital
 2011-10 PHASE4
NCT00961298 COMPLETED
Irritable Bowel Syndrome; Generalized Anxiety Disorder
West Penn Allegheny Health System
 2009-09 PHASE4
NCT00360724 COMPLETED
Dysthymic Disorder; Depressive Disorder NOS
New York State Psychiatric Institute
 2006-08 PHASE4
NCT00981149 COMPLETED
Temporomandibular Joint Disorders
University of Maryland, Baltimore
 2009-05
NCT01089556 COMPLETED
Diabetic Neuropathy, Painful
Eli Lilly and Company
 2010-03 PHASE3
NCT02903238 COMPLETED
Pain; Osteoarthritis
Northwestern University
 2011-07
NCT01404871 COMPLETED
Obsessive Compulsive Disorder
Sunnybrook Health Sciences Centre
 2009-04
NCT01140906 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
 2010-05 PHASE3
NCT01223001 TERMINATED
Traumatic Brain Injury; Depression
Rehabilitation Hospital of Indiana
 1996-09 PHASE2
NCT01425827 COMPLETED
Pain Reduction; Function Improvement
University of Alexandria
 2010-11
NCT01117857 COMPLETED
Depression; Menopause; Vasomotor Symptoms
Massachusetts General Hospital
 2009-08 PHASE4
NCT01018680 COMPLETED
Osteoarthritis Knee Pain
Eli Lilly and Company
 2009-11 PHASE3
NCT00849901 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2009-03 PHASE3
NCT01070329 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2010-03 PHASE4
NCT00849693 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2009-03 PHASE3
NCT00960986 COMPLETED
Major Depressive Disorder (MDD)
Eli Lilly and Company
 2009-08 PHASE4
NCT01078870 UNKNOWN
Schizophrenia
National Taiwan University Hospital
 2010-02 PHASE4
NCT00863057 TERMINATED
HIV Infections; Peripheral Neuropathy
National Institute of Allergy and Infectious Diseases (NIAID)
 2009-05 PHASE2
NCT01077375 COMPLETED
Fibromyalgia
Forest Laboratories
 2010-02 PHASE4
NCT00940693 COMPLETED
Attention Deficit Disorder With Hyperactivity
Université de Montréal
 2009-08 PHASE2
NCT00985504 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2009-09 PHASE4
NCT01145755 TERMINATED
Major Depressive Disorder
AstraZeneca
 2010-05 PHASE2
NCT00965081 COMPLETED
Fibromyalgia, Primary; Fibromyalgia, Secondary
Eli Lilly and Company
 2009-09 PHASE4
NCT01028352 COMPLETED
Breast Cancer
University of Michigan Rogel Cancer Center
 2008-10
NCT01000805 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2009-11 PHASE4
NCT01852383 COMPLETED
Depression; Dysthymic Disorder
New York State Psychiatric Institute
 2006-01 PHASE4
NCT01089621 WITHDRAWN
Fibromyalgia
Eli Lilly and Company
 2010-03 PHASE4
NCT00755807 COMPLETED
Multiple Sclerosis
Eli Lilly and Company
 2008-10 PHASE3
NCT00844194 COMPLETED
Diabetic Neuropathies; Depressive Disorder, Major
Boehringer Ingelheim
 2009-02 PHASE4
NCT00990067 COMPLETED
Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
University Hospital, Basel, Switzerland
 2009-11 PHASE1
NCT00945945 COMPLETED
Osteoarthritis Knee Pain
Eli Lilly and Company
 2009-07 PHASE3
NCT00696293 COMPLETED
Major Depressive Disorder; Back Pain; Aged
University of Pittsburgh
 2007-05 PHASE4
NCT00641719 COMPLETED
Diabetic Neuropathies
Eli Lilly and Company
 2008-03 PHASE3
NCT00811252 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
 2009-01 PHASE3
NCT00810069 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2008-11 PHASE4
NCT00388414 COMPLETED
Low Back Pain
Stanford University
 2006-09
NCT00803361 COMPLETED
Generalized Anxiety Disorder
Eli Lilly and Company
 2008-12 PHASE3
NCT00933452 COMPLETED
Healthy
Shanghai Mental Health Center
 2009-07 PHASE1
NCT00607789 COMPLETED
Binge Eating; Depression
University of Cincinnati
 2006-10 PHASE4
NCT00596986 UNKNOWN
Chronic Depression
Charite University, Berlin, Germany
 2008-10
NCT00177671 COMPLETED
Depression; Dementia
University of Pittsburgh
 2003-12 PHASE4
NCT00385671 COMPLETED
Diabetic Neuropathy, Painful
Eli Lilly and Company
 2006-09 PHASE4
NCT00837941 WITHDRAWN
Painful Diabetic Neuropathy
Merck Sharp & Dohme LLC
 2009-04 PHASE2
NCT00767806 COMPLETED
Chronic Low Back Pain
Eli Lilly and Company
 2008-09 PHASE3
NCT00552682 COMPLETED
Fibromyalgia; HIV-1 Infection
Germans Trias i Pujol Hospital
 2007-01 PHASE3
NCT00437125 COMPLETED
Major Depressive Disorder; Idiopathic Parkinson Disease
Eli Lilly and Company
 2007-03 PHASE4
NCT00696774 COMPLETED
Depressive Disorder, Major
Eli Lilly and Company
 2008-06 PHASE4
NCT00406848 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2006-11 PHASE4
NCT00200902 COMPLETED
Depression
University of California, Los Angeles
 2005-08 PHASE4
NCT00370656 COMPLETED
Diabetes Mellitus; Peripheral Neuropathies
University of Surrey
 2007-02 PHASE2; PHASE3
NCT01035073 COMPLETED
Major Depressive Disorder; Soft Tissue Discomfort Syndrome; Pain
University of Pennsylvania
 2006-04 PHASE4
NCT00673452 COMPLETED
Fibromyalgia
Eli Lilly and Company
 2008-06 PHASE4
NCT00763178 COMPLETED
Posttraumatic Stress Disorder
Yale University
 2007-02 EARLY_PHASE1
NCT00398632 TERMINATED
Depression
Stanford University
 2006-11 PHASE4
NCT00635219 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
 2008-02 PHASE3
NCT00532480 COMPLETED
Major Depression
Indiana University
 2007-09 PHASE4
NCT00149110 COMPLETED
Major Depression
Hillerod Hospital, Denmark
 2005-09
NCT00599911 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
 2007-10 PHASE2
NCT00552175 COMPLETED
Diabetic Neuropathies
Eli Lilly and Company
 2007-11 PHASE3
NCT00730691 COMPLETED
Generalized Anxiety Disorder
Takeda
 2008-06 PHASE3
NCT00666757 COMPLETED
Depression
Eli Lilly and Company
 2008-05 PHASE4
NCT00438971 COMPLETED
Panic Disorder
Massachusetts General Hospital
 2006-08 PHASE4
NCT00672620 COMPLETED
Major Depressive Disorder
Takeda
 2008-04 PHASE3
NCT00491348 TERMINATED
Worry; Anxiety
National Taiwan University Hospital
 2007-04
NCT00114127 COMPLETED
Anxiety Disorder
Massachusetts General Hospital
 2004-06 PHASE3
NCT00507936 COMPLETED
Diabetic Neuralgia; Diabetic Neuropathies; Diabetic Neuropathy, Painful; Diabetic Polyneuropathy; Neuralgia, Diabetic
AbbVie (prior sponsor, Abbott)
 2007-08 PHASE2
NCT00529789 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2007-08 PHASE2
NCT02229825 COMPLETED
Depressive Disorder, Major
Boehringer Ingelheim
 2007-02-09 PHASE4
NCT00603265 COMPLETED
Peripheral Neuropathy; Neuropathic Pain
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2007-11 PHASE2
NCT00422162 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2007-02 PHASE4
NCT00517985 COMPLETED
Major Depressive Disorder
University of Arizona
 2007-02 PHASE4
NCT02291341 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2008-05 PHASE1
NCT00331799 COMPLETED
Major Depressive Disorder
Duke University
 2007-04 PHASE2
NCT00536471 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2007-09 PHASE4
NCT02291367 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2008-05 PHASE1
NCT00433290 COMPLETED
Osteoarthritis Knee Pain
Eli Lilly and Company
 2007-02 PHASE3
NCT00401258 COMPLETED
Irritable Bowel Syndrome
Mclean Hospital
 2006-11 PHASE4
NCT00408993 COMPLETED
Diabetic Neuropathies
Eli Lilly and Company
 2006-12 PHASE3
NCT00105989 COMPLETED
Depressive Disorder, Major
Eli Lilly and Company
 2005-03 PHASE3
NCT00424593 COMPLETED
Back Pain Without Radiation
Eli Lilly and Company
 2007-01 PHASE3
NCT00408876 COMPLETED
Back Pain Without Radiation
Eli Lilly and Company
 2006-12 PHASE3
NCT00224302 COMPLETED
Psychotic Disorders
Central Institute of Mental Health, Mannheim
 2005-08 PHASE4
NCT00408421 COMPLETED
Osteoarthritis Knee Pain
Eli Lilly and Company
 2006-11 PHASE3
NCT00322621 COMPLETED
Diabetic Neuropathies
Eli Lilly and Company
 2006-04 PHASE4
NCT00533026 COMPLETED
Anticoagulant Effect of Warfarin When Taken With Duloxetine.
Eli Lilly and Company
 2007-07 PHASE1
NCT00933439 COMPLETED
Major Depressive Disorder
University of Texas Southwestern Medical Center
 2005-02
NCT00384033 COMPLETED
Depressive Disorder, Major
Pfizer
 2006-09 PHASE3
NCT00296699 COMPLETED
Atypical Depression
New York State Psychiatric Institute
 2005-03 PHASE4
NCT00387413 COMPLETED
Hyperalgesia
GlaxoSmithKline
 2006-10-02 PHASE1
NCT00609557 COMPLETED
Osteoarthritis; Pain
University of Washington
 2004-09 PHASE4
NCT01148472 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
 2005-09 PHASE4
NCT02232555 COMPLETED
Depressive Disorder, Major
Boehringer Ingelheim
 2005-05 PHASE3
NCT00185575 COMPLETED
Depressive Disorder
Stanford University
 2004-09
NCT02232542 COMPLETED
Healthy
Boehringer Ingelheim
 2003-06 PHASE1
NCT00073411 COMPLETED
Depression
Eli Lilly and Company
 2003-11 PHASE3
NCT00425230 TERMINATED
Chronic Phantom Limb Pain
Baylor College of Medicine
 2007-01
NCT00414323 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2006-11 PHASE1
NCT00191932 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2004-08 PHASE4
NCT00122863 COMPLETED
Anxiety Disorders
Eli Lilly and Company
 2005-01 PHASE3
NCT00191061 COMPLETED
Depressive Disorder
Eli Lilly and Company
 2004-10 PHASE4
NCT00058968 COMPLETED
Diabetic Neuropathy, Painful
Eli Lilly and Company
 2002-10 PHASE3
NCT00266643 COMPLETED
Diabetic Neuropathy, Painful
Eli Lilly and Company
 2005-12 PHASE4
NCT00122850 COMPLETED
Anxiety Disorders
Eli Lilly and Company
 2004-10 PHASE3
NCT00125892 COMPLETED
Fibromyalgia
Eli Lilly and Company
 2005-07 PHASE3
NCT00191204 COMPLETED
Urinary Incontinence Stress
Eli Lilly and Company
 2001-09 PHASE3
NCT00475397 COMPLETED
Urinary Incontinence, Stress
Eli Lilly and Company
 2003-12 PHASE3
NCT00321490 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-04 PHASE3
NCT00036309 COMPLETED
Depressive Disorder
Eli Lilly and Company
 2002-05 PHASE3
NCT00042575 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2002-06 PHASE3
NCT00190645 COMPLETED
Stress Urinary Incontinence
Eli Lilly and Company
 2001-02 PHASE3
NCT00190853 COMPLETED
Urinary Stress Incontinence
Eli Lilly and Company
 2005-01 PHASE3
NCT00136383 COMPLETED
Depressive Symptoms
Duke University
 2005-03 PHASE2; PHASE3
NCT00233025 COMPLETED
Fibromyalgia
Eli Lilly and Company
 2005-09 PHASE3
NCT00190827 COMPLETED
Urinary Incontinence, Stress
Eli Lilly and Company
 2003-09 PHASE3
NCT00215228 COMPLETED
Major Depressive Disorder
Duke University
 2005-07 PHASE2; PHASE3
NCT00351910 COMPLETED
Major Depressive Disorder
AstraZeneca
 2006-05 PHASE3
NCT00475696 COMPLETED
Urinary Incontinence
Eli Lilly and Company
 2002-11 PHASE2
NCT00191087 COMPLETED
Urinary Incontinence, Stress
Eli Lilly and Company
 2001-04 PHASE3
NCT00190606 COMPLETED
Urinary Stress Incontinence
Eli Lilly and Company
 2002-01 PHASE2
NCT00036335 COMPLETED
Depression; Pain
Eli Lilly and Company
 2002-03 PHASE3
NCT00191594 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2005-03 PHASE3
NCT00071695 COMPLETED
Depression
Eli Lilly and Company
 2003-07 PHASE4
NCT00489775 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2004-01 PHASE3
NCT00122824 COMPLETED
Anxiety Disorders
Eli Lilly and Company
 2004-06 PHASE3
NCT00190619 COMPLETED
Urinary Stress Incontinence
Eli Lilly and Company
 2001-05 PHASE3
NCT00190632 COMPLETED
Stress Urinary Incontinence
Eli Lilly and Company
 2001-03 PHASE3
NCT00062673 COMPLETED
Depression; Cognition
Eli Lilly and Company
 2003-03 PHASE3
NCT00190866 COMPLETED
Fibromyalgia
Eli Lilly and Company
 2005-06 PHASE3
NCT00191919 COMPLETED
Depressive Disorder, Major
Eli Lilly and Company
 2005-05 PHASE3
NCT00190567 COMPLETED
Urinary Stress Incontinence
Eli Lilly and Company
 2001-10 PHASE2
NCT00479726 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2004-08 PHASE4
NCT00399022 WITHDRAWN
OCD
Sheba Medical Center
NCT00475969 COMPLETED
Anxiety
Eli Lilly and Company
 2004-08 PHASE3
NCT00475358 COMPLETED
Urinary Incontinence, Stress
Eli Lilly and Company
 2003-04 PHASE3
NCT00531895 COMPLETED
Major Depression; Chronic Primary Headache
Kraepelin Psiquiatria Clinica
 2006-04 PHASE4
NCT00494377 COMPLETED
Depression
Eli Lilly and Company
 2004-02 PHASE4
NCT00190814 COMPLETED
Urinary Incontinence, Stress
Eli Lilly and Company
 2003-09 PHASE3
NCT00122837 COMPLETED
Anxiety Disorder
Eli Lilly and Company
 2005-04 PHASE3
NCT00366652 COMPLETED
Depression; Depressive Disorder; Depressive Disorder, Major
Wyeth is now a wholly owned subsidiary of Pfizer
 2006-09 PHASE3
NCT00190996 COMPLETED
Urinary Incontinence, Stress
Eli Lilly and Company
 2003-01 PHASE3
NCT00583193 UNKNOWN
Posttraumatic Stress Disorders
Canive, Jose M., M.D.
 2005-12 PHASE3
NCT00191685 COMPLETED
Depressive Disorder, Major
Eli Lilly and Company
 2004-05 PHASE3
NCT00042562 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
 2002-12 PHASE3
NCT00244296 COMPLETED
Urinary Incontinence, Stress
Eli Lilly and Company
 2005-10 PHASE4
NCT00489073 COMPLETED
Fibromyalgia
Eli Lilly and Company
 2002-11 PHASE3
NCT00190905 COMPLETED
Stress Urinary Incontinence
Eli Lilly and Company
 2004-02 PHASE4
NCT00067912 COMPLETED
Depression
Eli Lilly and Company
 2003-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-06-16)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Duloxetine acts as a serotonin-norepinephrine reuptake inhibitor by binding presynaptic serotonin and norepinephrine transporters to block neurotransmitter reuptake. This inhibition elevates synaptic concentrations of serotonin and norepinephrine in central synapses, enhancing descending inhibitory pain pathways and regulating mood pathways pertinent to major depressive disorder and chronic neuropathic pain conditions.

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>).

Jump to

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