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Paroxetine

Generic Name
Paroxetine
Brand Names
Paxil, Pexeva
Drug Type
Small Molecule
Chemical Formula
C19H20FNO3
CAS Number
61869-08-7
Unique Ingredient Identifier
41VRH5220H
Background

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) drug commonly known as Paxil. It has a variety of uses, including the treatment of anxiety disorders, major depression, posttraumatic stress disorder, and symptoms of menopause, among others. It was approved by the FDA in the early 1990s and marketed by SmithKline Beecham. A unique feature of this drug is that it is highly potent and selective in its inhibition of serotonin reuptake and has little effect on other neurotransmitters. Because of its potent inhibition of serotonin reuptake, paroxetine is more likely to cause withdrawal effects upon cessation. Paroxetine is well tolerated in most patients with a similar adverse effect profile to other members of its drug class. The controlled release formulation was designed to decrease the likelihood of nausea that is sometimes associated with paroxetine.

Indication

Paroxetine is indicated for the management of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder. One form of paroxetine, commercially known as Brisdelle, is used to manage mild to moderate vasomotor symptoms of menopause. Off-label, paroxetine may be used for the treatment of premature ejaculation or irritable bowel syndrome (IBS).

Associated Conditions
Generalized Anxiety Disorder, Irritable Bowel Syndrome (IBS), Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Panic Disorder, Post Traumatic Stress Disorder (PTSD), Premature Ejaculation, Premenstrual Dysphoric Disorder (PMDD), Social Anxiety Disorder (SAD), Vasomotor Symptoms Associated With Menopause

Management of Acute Tinnitus With Migraine Medications

Phase 4
Recruiting
Conditions
Tinnitus
Interventions
First Posted Date
2025-01-29
Last Posted Date
2025-05-02
Lead Sponsor
University of California, Irvine
Target Recruit Count
100
Registration Number
NCT06799169
Locations
🇺🇸

University of California, Irvine Medical Center ENT Clinic (Pavilion 2), Orange, California, United States

Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

Phase 2
Recruiting
Conditions
Hot Flashes
Menopause Syndrome
Menopause Surgical
Interventions
Dietary Supplement: Placebo
First Posted Date
2025-01-08
Last Posted Date
2025-01-08
Lead Sponsor
Universidad Nacional Autonoma de Honduras
Target Recruit Count
90
Registration Number
NCT06763484
Locations
🇭🇳

Instituto Hondureño de Seguridad Social, Tegucigalpa, Francisco Morazán, Honduras

Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects

Phase 1
Completed
Conditions
Drug Drug Interaction
Interventions
First Posted Date
2024-01-30
Last Posted Date
2024-12-18
Lead Sponsor
Asceneuron S.A.
Target Recruit Count
50
Registration Number
NCT06232109
Locations
🇳🇱

ICON Groningen Van Swietenlaan 6, Groningen, Netherlands

Paroxetine Safety and Efficacy in Rheumatoid Arthritis

Phase 3
Recruiting
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2024-01-30
Last Posted Date
2025-04-08
Lead Sponsor
Mostafa Bahaa
Target Recruit Count
100
Registration Number
NCT06231745
Locations
🇪🇬

Mostafa Bahaa, Damietta, New Damietta, Egypt

The G Protein-Coupled Receptor Kinase Type 2 Inhibitor Paroxetine as Adjunctive Therapy to Improve Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus

Phase 3
Not yet recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo
First Posted Date
2024-01-12
Last Posted Date
2024-01-12
Lead Sponsor
aya ramadan ashmawy sarhan
Target Recruit Count
44
Registration Number
NCT06203275

Concentration-QT Study of Paroxetine in Healthy Adults

Phase 1
Completed
Conditions
Anxiety Disorders
Interventions
First Posted Date
2023-10-04
Last Posted Date
2024-12-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
38
Registration Number
NCT06065735
Locations
🇬🇧

GSK Investigational Site, London, United Kingdom

A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Recruiting
Conditions
Hot Flashes
Interventions
Drug: Any other non-hormonal pharmacologic therapy prescribed for the treatment of VMS not included in a category above
Drug: Any other SSRI/SNRI not already specified
First Posted Date
2023-09-22
Last Posted Date
2025-04-24
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
1000
Registration Number
NCT06049797
Locations
🇺🇸

Alabama Clinical Therapeutics, Birmingham, Alabama, United States

🇺🇸

Accel Research Sites-Cahaba Medical Care-OBGYN, Birmingham, Alabama, United States

🇺🇸

Precision Trials AZ, LLC, Phoenix, Arizona, United States

and more 54 locations

Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome

First Posted Date
2023-09-06
Last Posted Date
2023-09-06
Lead Sponsor
Federico II University
Target Recruit Count
203
Registration Number
NCT06025474
Locations
🇮🇹

University of Naples Federico II, Napoli, Italia, Italy

Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2023-08-15
Last Posted Date
2024-01-25
Lead Sponsor
Dong-A ST Co., Ltd.
Target Recruit Count
37
Registration Number
NCT05992428
Locations
🇰🇷

Seoul National University Hospital, Soeul, Korea, Republic of

Effects of Paroxetine on Cardiovascular Function in Septic Patients

Phase 2
Recruiting
Conditions
Sepsis
Septic Shock
Interventions
First Posted Date
2023-02-13
Last Posted Date
2025-01-06
Lead Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Target Recruit Count
92
Registration Number
NCT05725837
Locations
🇧🇷

Hospital São José, Criciúma, Santa Catarina, Brazil

🇧🇷

Hospital Maternidade São José de Colatina, Colatina, Espirito Santo, Brazil

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