MedPath

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

Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

Phase 3
Completed
Conditions
Premature Ejaculation
Interventions
Drug: placebo
First Posted Date
2009-12-02
Last Posted Date
2009-12-02
Lead Sponsor
MorePharma Corporation
Target Recruit Count
174
Registration Number
NCT01024491
Locations
🇲🇽

Asociacion Mexicana para la Salud Sexual, A.C., Mexico City, Mexico D.F., Mexico

🇲🇽

Centro Especializado en Urología y Andrología del Hospital Star Médica, Mexico City, Mexico D.F, Mexico

Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects

Phase 1
Completed
Conditions
Depressive Disorder
Interventions
First Posted Date
2009-10-23
Last Posted Date
2018-06-19
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
26
Registration Number
NCT01000857
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects

First Posted Date
2009-07-13
Last Posted Date
2018-06-19
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
18
Registration Number
NCT00938184
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients

Phase 4
Terminated
Conditions
Major Depressive Disorder
Interventions
Drug: Paroxetine+Bupropion
Drug: Escitalopram+Mirtazapine
Drug: Paroxetine+Lamotrigine
Drug: Paroxetine+Lithium
Drug: Escitalopram+Aripiprazole
First Posted Date
2009-06-24
Last Posted Date
2015-09-02
Lead Sponsor
Ministry of Health & Welfare, Korea
Target Recruit Count
692
Registration Number
NCT00926835
Locations
🇰🇷

Clinical research center for depression, Seoul, Korea, Republic of

Lamotrigine Augmentation in Resistant Depression

Not Applicable
Completed
Conditions
Unipolar Depression
Interventions
First Posted Date
2009-05-13
Last Posted Date
2009-05-13
Lead Sponsor
Louisiana State University Health Sciences Center in New Orleans
Target Recruit Count
138
Registration Number
NCT00901407
Locations
🇺🇸

LSUHSC- New Orleans, New Orleans, Louisiana, United States

Interaction Study of Timolol Eye Drops and Paroxetine Capsules

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-04-09
Last Posted Date
2010-01-28
Lead Sponsor
Santen Oy
Target Recruit Count
12
Registration Number
NCT00879099
Locations
🇫🇮

University of Helsinki, Department of Clinical Pharmacology, Helsinki, Biomedicum, Finland

Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)

First Posted Date
2009-03-20
Last Posted Date
2017-01-30
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
416
Registration Number
NCT00866294
Locations
🇰🇷

GSK Investigational Site, Seoul, Korea, Republic of

Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-11
Last Posted Date
2024-08-19
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
24
Registration Number
NCT00841659
Locations
🇨🇦

Anapharm Inc., Sainte-Foy, Quebec, Canada

Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-11
Last Posted Date
2024-08-19
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
50
Registration Number
NCT00841698
Locations
🇨🇦

Anapharm Inc., Sainte-Foy, Quebec, Canada

BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

Phase 3
Completed
Conditions
Post-Traumatic Stress Disorder
Interventions
First Posted Date
2009-02-09
Last Posted Date
2014-03-10
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
52
Registration Number
NCT00839397
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