How many clinical trials are studying Sertraline?

9 recruiting trials in our tracked data involve Sertraline.

What conditions is Sertraline being studied for?

In our tracked recruiting trials, Sertraline is being studied in trials for Depression, Anxiety, Major Depressive Disorder.

Sertraline: clinical trials recruiting now

Q: Is Sertraline FDA-approved?

Yes. According to the FDA drug label available through openFDA, Sertraline is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Sertraline appears in the FDA drug-label database. Marketed as Sertraline.
Boxed warning: The FDA label for Sertraline carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies ( 14 ) ]: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD)

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. — Legacy Pharmaceutical Packaging LLC	Class II (FDA: may cause temporary or reversible harm)	Ongoing	2023-12-11
Defective container - seal not adhering to bottles — Lupin Pharmaceuticals Inc.	Class II (FDA: may cause temporary or reversible harm)	Ongoing	2025-11-05

FDA label via openFDA

Phase breakdown

Phase 1 1 Phase 2 4 Phase 3 2 Phase 4 2 Not applicable 1

Conditions being studied

Condition	Trials
Depression · Sertraline for Depression	6
Anxiety · Sertraline for Anxiety	3
Major Depressive Disorder · Sertraline for Major Depressive Disorder	3
Anxiety Disorders	2
Bipolar Depression	2
Bipolar disorder	2
22Q11 Deletion	1
22Q11 Deletion Syndrome	1
ADHD	1
ADHD - Combined Type	1
ADHD Predominantly Inattentive Type	1
ADHD, Predominantly Hyperactive - Impulsive	1
Autism	1
Autism Spectrum Disorder	1
Chronic Major Depression, Recurrent	1

Recruiting trials involving Sertraline

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
NCT05892744 · Phase: Phase 4 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 1 location
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
NCT05603104 · Phase: Phase 3 · Ages: 18 Years to 70 Years · Sex: All (male and female) · 1 location
NMDA Modulation in Major Depressive Disorder
NCT04637620 · Phase: Phase 2 · Ages: 18 Years to 55 Years · Sex: All (male and female) · 1 location
Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
NCT05683223 · Phase: Not applicable (e.g. observational or device study) · Ages: 18 Years to 50 Years · Sex: All (male and female) · 1 location
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
NCT05814640 · Phase: Phase 1, Phase 2 · Ages: 13 Years to 18 Years · Sex: All (male and female) · 1 location
Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression
NCT07645157 · Phase: Phase 2 · Ages: 12 Years to 18 Years · Sex: All (male and female) · 1 location
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
NCT06081348 · Phase: Phase 2 · Ages: 8 Years to 17 Years · Sex: All (male and female) · 7 locations
The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
NCT05973786 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 13 locations
Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
NCT04221997 · Phase: Phase 4 · Ages: 8 Years to 17 Years · Sex: All (male and female) · 1 location

Common questions

Is Sertraline FDA-approved?

Yes, marketed as Sertraline. Its FDA label carries a boxed warning.

How many recruiting trials involve Sertraline?

9 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.