Sertraline

Generic Name: Sertraline

Brand Names: Zoloft

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₇Cl_₂N

CAS Number: 79617-96-2

Unique Ingredient Identifier: QUC7NX6WMB

Background: Sertraline is a popular antidepressant medication commonly known as a selective serotonin reuptake inhibitor (SSRI), and is similar to drugs such as Citalopram and Fluoxetine. Despite marked structural differences between compounds in this drug class, SSRIs exert similar pharmacological effects.

Several weeks of therapy with sertraline may be required before beneficial effects are noticed. Sertraline displays enhanced safety or tolerability than other classes of antidepressants, which frequently cause high levels of drowsiness, dizziness, blurred vision, and other undesirable effects.

Indication: Sertraline is indicated for the management of major depressive disorder (MDD), post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), panic disorder (PD), premenstrual dysphoric disorder (PMDD), and social anxiety disorder (SAD). Common off-label uses for sertraline include the prevention of post stroke depression, generalized anxiety disorder (GAD), fibromyalgia, premature ejaculation, migraine prophylaxis, diabetic neuropathy, and neurocardiogenic syncope.

Associated Conditions: Binge Eating Disorder (BED), Bulimia Nervosa, Generalized Anxiety Disorder, Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Panic Disorder, Post Traumatic Stress Disorder (PTSD), Premenstrual Dysphoric Disorder (PMDD), Social Anxiety Disorder (SAD)

Clinical Trials

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Phase 3

Withdrawn

Conditions: Depressive Disorder, Treatment-Resistant

Interventions: Drug: Esketamine 28 mg
Drug: Placebo
Drug: Esketamine 56 mg
Drug: Esketamine 84 mg
Drug: Escitalopram
Drug: Sertraline
Drug: Duloxetine
Drug: Mirtazapine
Drug: Trazodone Prolonged Release
Drug: Agomelatine
Drug: Bupropion

First Posted Date: 2019-02-25

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen-Cilag International NV

Registration Number: NCT03852160

Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment

Phase 4

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Vortioxetine
Drug: Sertraline
Drug: citalopram
Drug: Escitalopram
Drug: Paroxetine
Drug: Fluoxetine
Drug: Fluvoxamine

First Posted Date: 2018-12-19

Last Posted Date: 2023-05-19

Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Target Recruit Count: 362

Registration Number: NCT03779789

Locations: 🇮🇹
Azienda Ospedaliera Universitaria Mater Domini, Università Magna Grecia, Catanzaro, Italy
🇮🇹
Sapienza Università di Roma, Dipartimento di Neurologia e Psichiatria, Roma, Italy
🇮🇹
Azienda Ospedaliera Universitaria Verona, Verona, Italy

Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: Zoloft Oral Solution
Drug: Zoloft tablets

First Posted Date: 2018-10-18

Last Posted Date: 2021-01-27

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 36

Registration Number: NCT03711708

Locations: 🇧🇷
ICF - Instituto de Ciencias Farmaceuticas de Estudos e Pesquisas Ltda, Aparecida de Goiania, GO, Brazil

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting

Conditions: Breastfed Infants of Mothers on Select DOI
Lactating Women on Select DOI

First Posted Date: 2018-04-27

Last Posted Date: 2024-12-17

Lead Sponsor: Duke University

Target Recruit Count: 1600

Registration Number: NCT03511118

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States
🇺🇸
Loma Linda University Health, Loma Linda, California, United States

and more 19 locations

Cognitive Processing Therapy vs. Sertraline for the Treatment of PTSD & SUD in Egyptian Patients

Phase 1

Completed

Conditions: Psychologic Manipulation

Interventions: Other: Placebo Control
Behavioral: Cognitive processing therapy
Drug: Sertraline

First Posted Date: 2018-03-19

Last Posted Date: 2021-04-01

Lead Sponsor: British University In Egypt

Target Recruit Count: 150

Registration Number: NCT03469128

A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Phase 3

Completed

Conditions: Depressive Disorder, Treatment-Resistant

Interventions: Drug: Esketamine 56 mg
Drug: Placebo
Drug: Esketamine 84 mg
Drug: Duloxetine (Oral Antidepressant)
Drug: Escitalopram (Oral Antidepressant)
Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant)
Drug: Sertraline (Oral Antidepressant)

First Posted Date: 2018-02-15

Last Posted Date: 2025-04-29

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 252

Registration Number: NCT03434041

Locations: 🇺🇸
The Medical Research Network, LLC, New York, New York, United States
🇨🇳
Beijing HuiLong Guan Hospital, Beijing, China
🇺🇸
Atlanta Center for Medical Research, Atlanta, Georgia, United States

and more 27 locations