Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate Paroxetine HCl across various neuropsychiatric and systemic conditions, including major depressive disorder, anxiety, insomnia, post-traumatic stress disorder, and vasomotor symptoms. Sponsored by academic institutions, medical research foundations, and pharmaceutical entities, these studies feature recruitment statuses ranging from completed and actively recruiting to withdrawn or not yet recruiting. Research encompasses drug-interaction studies, comparative symptom management, and novel applications such as G-protein coupled receptor kinase 2 inhibition in rheumatoid arthritis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07070232 RECRUITING
Advanced Solid Tumor
BioNTech SE
2025-08-12 PHASE1; PHASE2
NCT07318181 RECRUITING
Post Traumatic Stress Disorder; Post Traumatic Stress Disorder PTSD; Post-Traumatic Stress Disorder, PTSD
University of Luxembourg
2026-01-01
NCT07715669 RECRUITING
Preeclampsia; Endothelial Function
Anna Stanhewicz, PhD
2026-08-30 EARLY_PHASE1
NCT07025590 RECRUITING
Cardiovascular Diseases (CVD); Depression Anxiety Disorder
Guangdong Provincial People's Hospital
2025-04-22
NCT06796946 NOT_YET_RECRUITING
Deprescription; Antidepressants
University of Huelva
2026-06 EARLY_PHASE1
NCT06799169 ACTIVE_NOT_RECRUITING
Tinnitus
University of California, Irvine
2025-06-01 PHASE4
NCT04961190 ACTIVE_NOT_RECRUITING
Posttraumatic Stress Disorder
University of Pennsylvania
2022-05-25 PHASE4
NCT07669571 NOT_YET_RECRUITING
Healthy Adult Participants
NeuShen Therapeutics
2026-06 PHASE1
NCT07057011 NOT_YET_RECRUITING
Premature Ejaculation
South Valley University
2025-07-01
NCT05725837 COMPLETED
Septic Shock; Sepsis
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
2023-06-10 PHASE2
NCT04207723 COMPLETED
Premature Ejaculation
Boston Medical Group
2020-07-15
NCT06763484 COMPLETED
Menopause Syndrome; Menopause Surgical; Hot Flashes
Universidad Nacional Autonoma de Honduras
2025-01-30 PHASE2
NCT06231745 COMPLETED
Rheumatoid Arthritis
Mostafa Bahaa
2024-01-31 PHASE3
NCT06203275 UNKNOWN
Diabetes Mellitus, Type 2
aya ramadan ashmawy sarhan
2024-01 PHASE3
NCT04757571 WITHDRAWN
Rheumatoid Arthritis
Sadat City University
2021-02-01 PHASE1; PHASE2
NCT06232109 COMPLETED
Drug Drug Interaction
Asceneuron S.A.
2024-02-22 PHASE1
NCT05175430 COMPLETED
Healthy
University Hospital, Basel, Switzerland
2022-10-24 PHASE1
NCT06065735 COMPLETED
Anxiety Disorders
GlaxoSmithKline
2023-10-02 PHASE1
NCT04404439 COMPLETED
Tinnitus, Subjective; Tinnitus
University of California, Irvine
2019-09-26 PHASE4
NCT05637671 UNKNOWN
Vasomotor Symptoms
Cairo University
2022-02-10 PHASE3
NCT05992428 COMPLETED
Healthy
Dong-A ST Co., Ltd.
2023-08-22 PHASE1
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
NCT04218981 COMPLETED
Common Mental Disorder
Central South University
2020-01-15
NCT05588102 COMPLETED
Geriatric Depression; Cognitive Impairment
Capital Medical University
2021-05-18
NCT05730062 Not yet recruiting
Opioid Induced Respiratory Depression|Depressive Disorder|Anxiety Disorders
Leiden University Medical Center
2023-03-15 Phase 1
NCT03779789 COMPLETED
Major Depressive Disorder
Azienda Ospedaliera Universitaria Integrata Verona
2019-02-01 PHASE4
NCT03894085 COMPLETED
Anxiety Disorder; Obsessive-Compulsive Disorder
Central South University
2019-05-30
NCT05637671 Recruiting
Vasomotor Symptoms
Cairo University
2022-02-10 Phase 3
NCT05188833 UNKNOWN
Obsessive-Compulsive Disorder; EEG With Periodic Abnormalities
Istanbul Medipol University Hospital
2020-05-17
NCT04650542 COMPLETED
Drug-drug Interaction
HUYABIO International, LLC.
2021-02-21 PHASE1
NCT04888728 COMPLETED
Idiopathic Pulmonary Fibrosis
Daewoong Pharmaceutical Co. LTD.
2021-06-30 PHASE1
NCT04981704 COMPLETED
Healthy
Spectrum Pharmaceuticals, Inc
2021-04-08 PHASE1
NCT04310579 COMPLETED
Hypercapnia; Ventilatory Depression
Food and Drug Administration (FDA)
2020-06-15 PHASE1
NCT04311463 COMPLETED
Anxiety Disorders
GlaxoSmithKline
2020-12-09 PHASE1
NCT03274752 COMPLETED
Cardiac Remodeling; Myocardial Infarction
Insel Gruppe AG, University Hospital Bern
2017-10-26 PHASE2
NCT03879746 UNKNOWN
Premature Ejaculation
Assiut University
2019-04 PHASE3
NCT03277339 COMPLETED
Generalized Anxious Disorders
Centre Hospitalier Henri Laborit
2017-01-19 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
NCT04188028 COMPLETED
Healthy
Jules Desmeules
2019-01-01
NCT03054220 COMPLETED
Healthy
Jules Desmeules
2016-07
NCT03329573 COMPLETED
Anxiety Disorders
GlaxoSmithKline
2018-05-30 PHASE1
NCT03504475 COMPLETED
Major Depressive Disorder; Obsessive-Compulsive Disorder; Panic Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder
Beijing Tongren Hospital
2018-03-29 PHASE1
NCT03312777 COMPLETED
Pain
Syntrix Biosystems, Inc.
2017-10-31 PHASE1
NCT02022709 COMPLETED
Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders
Shanghai Mental Health Center
2014-01 PHASE4
NCT03149419 COMPLETED
Postmenopausal Flushing; Cardiovascular Risk Factor; Endothelial Dysfunction
Rio de Janeiro State University
2016-03-01 PHASE4
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
2015-01 PHASE3
NCT02932904 COMPLETED
Healthy Volunteers
Takeda
2016-11-21 PHASE4
NCT01360866 COMPLETED
Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
Otsuka Pharmaceutical Development & Commercialization, Inc.
2011-10 PHASE3
NCT01458626 COMPLETED
Major Depression
Capital Medical University
2012-11-14 PHASE4
NCT02681198 COMPLETED
Healthy
USWM, LLC (dba US WorldMeds)
2016-01 PHASE1
NCT01354314 COMPLETED
HIV Associated Neurocognitive Disorder
Johns Hopkins University
2010-11 PHASE1; PHASE2
NCT02279966 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
2014-10 PHASE3
NCT02273154 UNKNOWN
Major Depression Disorder
Si Tianmei
2014-08 PHASE4
NCT01987960 TERMINATED
Post-traumatic Stress Disorder; PTSD
H. Lundbeck A/S
2013-12 PHASE3
NCT01608295 COMPLETED
Major Depressive Disorder
University of California, Los Angeles
2012-07 PHASE4
NCT00338962 COMPLETED
Alcoholism; Depression; PTSD
Yale University
2001-10 PHASE3
NCT01681849 COMPLETED
PTSD
Emory University
2009-07 PHASE4
NCT00926835 TERMINATED
Major Depressive Disorder
Ministry of Health & Welfare, Korea
2009-05 PHASE4
NCT01748955 COMPLETED
Depression; Suicidal Ideation
New York State Psychiatric Institute
2010-06 PHASE4
NCT02237937 UNKNOWN
Major Depression
HolsboerMaschmeyer NeuroChemie GmbH
2011-09 PHASE4
NCT01289756 COMPLETED
Anovulation; Disorder Due Cytochrome P450 CYP2D6 Variant; Cytochrome P450 CYP3A Enzyme Deficiency
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
2009-12 PHASE1
NCT01764867 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
2012-06 PHASE4
NCT02097147 COMPLETED
Healthy
Forest Laboratories
2014-03 PHASE1
NCT02451475 COMPLETED
Fibromyalgia
Mansoura University
2013-02 PHASE1; PHASE2
NCT01841502 TERMINATED
Hepatitis C Infection; Depression
Radboud University Medical Center
2013-05 PHASE2
NCT01916200 WITHDRAWN
Depressive Disorder
GlaxoSmithKline
2014-01 PHASE4
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
2013-04
NCT02174822 COMPLETED
Drug-drug Interaction
Otsuka Pharmaceutical Development & Commercialization, Inc.
2014-01 PHASE1
NCT01318434 COMPLETED
Major Depressive Disorder
Euthymics BioScience, Inc.
2011-02 PHASE2; PHASE3
NCT01416220 WITHDRAWN
Major Depressive Disorder
Nova Scotia Health Authority
2011-09 PHASE4
NCT00400088 TERMINATED
Major Depressive Disorder
Nova Scotia Health Authority
2007-06 PHASE3
NCT02191124 COMPLETED
Major Depressive Disorder
Capital Medical University
2011-06 PHASE4
NCT02852577 COMPLETED
Panic Disorder; Agoraphobia
Universidade Federal do Rio de Janeiro
2000-01 PHASE4
NCT01254305 COMPLETED
Major Depressive Disorder
Forest Laboratories
2011-04 PHASE2
NCT00291148 COMPLETED
Neuropathic Pain; Multiple Sclerosis
University of Manitoba
2006-03 PHASE3
NCT00700999 COMPLETED
Post-traumatic Stress Disorder
US Department of Veterans Affairs
2008-10 PHASE4
NCT00665678 TERMINATED
Posttraumatic Stress Disorder (PTSD)
Foundation for Atlanta Veterans Education and Research, Inc.
2008-04 PHASE4
NCT01386593 COMPLETED
Metabolic Detoxication, Phase I
University Hospital, Basel, Switzerland
2011-05 PHASE1
NCT01361308 COMPLETED
Postmenopausal Symptoms
Noven Therapeutics
2011-05 PHASE3
NCT01101841 COMPLETED
Hot Flashes
Noven Therapeutics
2010-03 PHASE3
NCT01829919 COMPLETED
Postmenopausal Symptoms
Noven Therapeutics
2011-07 PHASE1
NCT00403455 COMPLETED
PTSD
VA Office of Research and Development
2006-10 PHASE3
NCT01318031 COMPLETED
Healthy Volunteers
Pfizer
2011-03 PHASE1
NCT00641173 WITHDRAWN
Post-Traumatic Stress Disorders
US Department of Veterans Affairs
2008-09
NCT00812812 TERMINATED
Depressive Disorder
GlaxoSmithKline
2009-03 PHASE4
NCT00519012 UNKNOWN
Depression
Oizumi Hospital
2007-08 PHASE4
NCT00594269 COMPLETED
Dementia
Sykehuset Innlandet HF
2008-08 PHASE4
NCT00218439 COMPLETED
Tobacco Use Disorder
University of Minnesota
2005-10
NCT01000857 COMPLETED
Depressive Disorder
GlaxoSmithKline
2009-11-05 PHASE1
NCT01130103 COMPLETED
Posttraumatic Stress Disorder
Research Foundation for Mental Hygiene, Inc.
2004-03 PHASE4
NCT00866294 COMPLETED
Depressive Disorder
GlaxoSmithKline
2009-04 PHASE3
NCT00677352 COMPLETED
Panic Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2008-05 PHASE4
NCT00429169 TERMINATED
Depression
New York State Psychiatric Institute
2004-06 PHASE4
NCT00879099 COMPLETED
Healthy
Santen Oy
2009-04 PHASE1
NCT00184106 COMPLETED
Phobic Disorders
Norwegian University of Science and Technology
2004-10 PHASE4
NCT00736346 UNKNOWN
Panic Disorder; Anxiety Disorder; Mental Disorder
Université du Québec a Montréal
2005-10
NCT01339247 COMPLETED
Depressive Disorder
GlaxoSmithKline
2009-10-20 PHASE1
NCT00086190 COMPLETED
Parkinson Disease; Depression
University of Rochester
2005-06 PHASE3
NCT01316926 COMPLETED
Depressive Disorder
GlaxoSmithKline
2009-09-09 PHASE1
NCT00938184 COMPLETED
Depressive Disorder
GlaxoSmithKline
2009-07-14 PHASE1
NCT00394056 COMPLETED
Tinnitus
GlaxoSmithKline
2006-12 PHASE2
NCT00786188 COMPLETED
Hot Flashes
Noven Therapeutics
2008-11 PHASE2
NCT00658762 TERMINATED
Generalized Anxiety Disorder
Pfizer
2008-05 PHASE3
NCT00658372 TERMINATED
Generalized Anxiety Disorder
Pfizer
2008-05 PHASE3
NCT00658008 TERMINATED
Generalized Anxiety Disorder
Pfizer
2008-04 PHASE3
NCT01024491 COMPLETED
Premature Ejaculation
MorePharma Corporation
2008-08 PHASE3
NCT00629551 COMPLETED
Depressive Disorder, Major
Sanofi
2008-02 PHASE3
NCT00445679 COMPLETED
Depressive Disorder, Major
Wyeth is now a wholly owned subsidiary of Pfizer
2007-07 PHASE3
NCT00836069 TERMINATED
Anxiety Disorders
Cedars-Sinai Medical Center
2008-10 PHASE3
NCT00666757 COMPLETED
Depression
Eli Lilly and Company
2008-05 PHASE4
NCT00470483 COMPLETED
Social Phobia
GlaxoSmithKline
2007-01-22 PHASE1
NCT00062738 COMPLETED
Parkinson Disease; Depression
Rutgers, The State University of New Jersey
2003-06 PHASE2
NCT00557622 TERMINATED
Post-Traumatic Stress Disorder; Stress Disorders, Post-Traumatic
GlaxoSmithKline
2008-01-25 PHASE2
NCT02264184 COMPLETED
Healthy
Boehringer Ingelheim
2008-09 PHASE1
NCT00292370 COMPLETED
Combat Disorders; Stress Disorders, Post-Traumatic
VA Office of Research and Development
2006-01 PHASE4
NCT00749359 COMPLETED
Depressive Disorder
GlaxoSmithKline
2008-07-07 PHASE1
NCT00680602 COMPLETED
Obsessive Compulsive Disorder
University of Sao Paulo
2006-01 PHASE4
NCT00785603 UNKNOWN
Depression; Pain
University of Southern Denmark
2008-08 PHASE4
NCT00560612 COMPLETED
Stress Disorders, Post-Traumatic
Durham VA Medical Center
2006-01 PHASE4
NCT00420641 COMPLETED
Depressive Disorder
GlaxoSmithKline
2006-12-19 PHASE2
NCT00463242 COMPLETED
Major Depressive Disorder
Novartis
2007-03 PHASE3
NCT00074802 COMPLETED
Social Anxiety Disorder
Temple University
2003-12 PHASE3
NCT00246441 COMPLETED
Social Anxiety Disorder; Social Phobia; Alcohol Use Disorder; Alcohol Abuse; Alcohol Dependence
Medical University of South Carolina
2002-03 PHASE4
NCT00374166 COMPLETED
Anxiety Disorders
Sanofi
2006-08 PHASE2
NCT00202449 TERMINATED
Stress Disorders, Post-Traumatic; Sleep Disorders
Seattle Institute for Biomedical and Clinical Research
2004-07
NCT00385307 COMPLETED
Major Depressive Disorder
Sanofi
2006-09 PHASE3
NCT00397722 COMPLETED
Social Phobia
GlaxoSmithKline
2006-11-09 PHASE2
NCT00361491 COMPLETED
Depressive Disorder
Sanofi
2006-08 PHASE2
NCT00672776 COMPLETED
Posttraumatic Stress Disorder (PTSD)
Emory University
2003-05 PHASE4
NCT00261729 COMPLETED
Sleep Disorders; Stress Disorders, Post-Traumatic
US Department of Veterans Affairs
2004-07
NCT00249847 TERMINATED
Hot Flashes
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2005-10
NCT00767754 COMPLETED
Panic Disorder
Samsung Medical Center
2007-01 PHASE4
NCT00332891 COMPLETED
Anxiety Disorders
Sanofi
2006-03 PHASE3
NCT00113295 COMPLETED
Anxiety Disorder
Massachusetts General Hospital
2004-02 PHASE4
NCT00266747 COMPLETED
Anxiety Disorders
Sanofi
2005-12 PHASE3
NCT00648193 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2006-12 EARLY_PHASE1
NCT00650403 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2006-12 PHASE1
NCT00318669 COMPLETED
Social Phobia
GlaxoSmithKline
2005-12 PHASE3
NCT00744406 COMPLETED
Depression; Major Depressive Disorder
Centre for Addiction and Mental Health
2003-07 PHASE2
NCT00273039 COMPLETED
Social Anxiety Disorder; Anxiety Disorders
GlaxoSmithKline
2005-08 PHASE2
NCT00413023 COMPLETED
Depressive Disorder, Major
GlaxoSmithKline
2005-06 PHASE2
NCT01367535 COMPLETED
Healthy Adults
Bausch Health Americas, Inc.
2006-03 PHASE1
NCT00901407 COMPLETED
Unipolar Depression
Louisiana State University Health Sciences Center in New Orleans
2003-12
NCT00406432 COMPLETED
Depressive Disorder
GlaxoSmithKline
2006-05-09 PHASE1
NCT00229528 COMPLETED
Coronary Artery Disease
University of Oklahoma
2004-03 PHASE4
NCT00406003 COMPLETED
Depressive Disorder
GlaxoSmithKline
2006-03-24 PHASE1
NCT00195598 COMPLETED
Panic Disorders
Wyeth is now a wholly owned subsidiary of Pfizer
2005-01 PHASE3
NCT00259883 COMPLETED
Mental Disorders
GlaxoSmithKline
2005-06 PHASE4
NCT00264654 COMPLETED
Social Phobia
GlaxoSmithKline
2005-10 PHASE3
NCT00343707 COMPLETED
Depressive Disorder and Anxiety Disorders
GlaxoSmithKline
2004-11 PHASE2
NCT00135525 COMPLETED
Anxiety Disorder; Anxiety Disorders
GlaxoSmithKline
2003-05 PHASE2
NCT00206765 TERMINATED
Major Depressive Disorder With Panic Attacks; Panic Disorder
Beth Israel Medical Center
2003-01 PHASE2
NCT00647881 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2005-04 PHASE1
NCT00648427 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2005-04 PHASE1
NCT00067444 COMPLETED
Depressive Disorder, Major; Major Depressive Disorder (MDD)
GlaxoSmithKline
2003-06 PHASE3
NCT00839397 COMPLETED
Post-Traumatic Stress Disorder
GlaxoSmithKline
2002-05 PHASE3
NCT00825019 COMPLETED
Major Depressive Disorders
Sanofi
2003-09 PHASE3
NCT00000368 COMPLETED
Panic Disorder; Agoraphobia
New York State Psychiatric Institute
1999-02 PHASE3
NCT00825058 COMPLETED
Major Depressive Disorders
Sanofi
2003-11 PHASE3
NCT00048607 COMPLETED
Major Depressive Disorder
Merck Sharp & Dohme LLC
2002-07-30 PHASE3
NCT00034983 COMPLETED
Major Depressive Disorder
Merck Sharp & Dohme LLC
2001-10-29 PHASE3
NCT00035009 COMPLETED
Major Depressive Disorder
Merck Sharp & Dohme LLC
2001-09-20 PHASE3
NCT00100464 COMPLETED
Obstructive Sleep Apnea
US Department of Veterans Affairs
2000-11 PHASE4
NCT00048204 COMPLETED
Depressive Disorder, Major
GlaxoSmithKline
2002-11-04 PHASE2
NCT00049972 COMPLETED
Major Depressive Disorder
GlaxoSmithKline
2002-09 PHASE4
NCT00457106 COMPLETED
Major Depression With Panic Attacks; Panic Disorder
Beth Israel Medical Center
2002-06
NCT00044772 COMPLETED
Panic Disorder
Wyeth is now a wholly owned subsidiary of Pfizer
2001-11 PHASE3
NCT00610909 COMPLETED
Irritable Bowel Syndrome
Duke University
2002-01 PHASE4
NCT00610610 COMPLETED
Fibromyalgia Syndrome
Duke University
2002-01 PHASE4
NCT00841698 COMPLETED
Healthy
Teva Pharmaceuticals USA
2002-10 PHASE1
NCT00841659 COMPLETED
Healthy
Teva Pharmaceuticals USA
2002-08 PHASE1
NCT01049347 COMPLETED
Unipolar Depression
Central Institute of Mental Health, Mannheim
1997-10 PHASE3
NCT00119652 COMPLETED
Bipolar Disorder; Bipolar Depression; Depression
AstraZeneca
2005-05 PHASE3
NCT00516113 COMPLETED
Premenstrual Dysphoric Disorder; Premenstrual Syndrome
Karolinska Institutet
2000-10 PHASE4
NCT00136383 COMPLETED
Depressive Symptoms
Duke University
2005-03 PHASE2; PHASE3
NCT00351910 COMPLETED
Major Depressive Disorder
AstraZeneca
2006-05 PHASE3
NCT00196664 COMPLETED
Chronic Hepatitis C
French National Agency for Research on AIDS and Viral Hepatitis
2005-10 PHASE3
NCT00322595 COMPLETED
Generalized Anxiety Disorder
AstraZeneca
2006-05 PHASE3
NCT00178100 COMPLETED
Unipolar Depression
University of Pittsburgh
1999-03 PHASE4
NCT00620581 COMPLETED
Premenstrual Dysphoric Disorder
Hamilton Health Sciences Corporation
PHASE3
NCT01159821 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2010-08 PHASE1
NCT00018759 COMPLETED
Depression; Hypertension
US Department of Veterans Affairs
2001-03 PHASE4
NCT00456560 COMPLETED
Healthy
Avigen
2007-04 PHASE1
NCT00403962 COMPLETED
Social Phobia
GlaxoSmithKline
2004-11 PHASE2
NCT00018733 COMPLETED
Depression
US Department of Veterans Affairs
1996-09
NCT00357045 COMPLETED
Major Depression
Portland VA Medical Center
PHASE4
NCT00489775 COMPLETED
Major Depressive Disorder
Eli Lilly and Company
2004-01 PHASE3
NCT00791713 COMPLETED
Schizophrenia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2006-03 PHASE1
NCT00191022 COMPLETED
Social Phobia
Eli Lilly and Company
2004-12 PHASE2
NCT00209118 COMPLETED
Hepatitis C; Depression; Interferon-alpha Associated Side Effects
Emory University
NCT00492414 UNKNOWN
Panic Disorder
Inje University
PHASE4
NCT00269334 UNKNOWN
Major Depression
National Health Research Institutes, Taiwan
2005-12 PHASE4
NCT00540098 COMPLETED
Panic Disorder
University of Göttingen
2001-09 PHASE4
NCT00456898 COMPLETED
Depressive Disorder, Major; Diabetic Neuropathies; Fibromyalgia; Vasomotor Symptoms
Wyeth is now a wholly owned subsidiary of Pfizer
2007-01 PHASE1
NCT00330239 COMPLETED
PTSD
Medical University of South Carolina
2003-01 PHASE4
NCT00177567 COMPLETED
Bipolar Disorder
University of Pittsburgh
2001-07 PHASE4
NCT00178035 COMPLETED
Depression
University of Pittsburgh
1999-12 PHASE4
NCT00025740 COMPLETED
Post Traumatic Stress Disorder
National Institute of Mental Health (NIMH)
2001-10 PHASE4
NCT00215163 COMPLETED
Stress Disorders, Post-Traumatic
Duke University
2002-12 PHASE2; PHASE3
NCT00715039 COMPLETED
Anxiety Disorders
Pfizer
2003-10
NCT00178048 COMPLETED
Primary Insomnia; Depression
University of Pittsburgh
1998-09 PHASE4
NCT00121888 COMPLETED
Stress Disorders, Post-Traumatic
Massachusetts General Hospital
2002-12 PHASE1; PHASE2
NCT00368303 COMPLETED
Depressive Disorder, Major; Major Depressive Disorder (MDD)
GlaxoSmithKline
2006-12 PHASE3
NCT00012558 COMPLETED
Bipolar Disorder
National Institute of Mental Health (NIMH)
1998-09
NCT00073203 COMPLETED
Major Depressive Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PHASE2
NCT00225914 COMPLETED
Menopause
Massachusetts General Hospital
2004-09 PHASE4
NCT00031317 COMPLETED
Panic Disorder
National Institute of Mental Health (NIMH)
2002-02 PHASE4
NCT00329147 COMPLETED
Depression
Wyeth is now a wholly owned subsidiary of Pfizer
2006-05 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-09-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paroxetine HCl functions as a potent and selective inhibitor of the presynaptic serotonin transporter, binding directly to the carrier protein to block the reuptake of extracellular serotonin into presynaptic terminals. This inhibition elevates active synaptic serotonin concentrations within the central nervous system, enhancing serotonergic signaling to mitigate symptoms in clinical trial conditions such as major depressive disorder, panic disorders, and anxiety disorders.

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.