Fluoxetine

Generic Name: Fluoxetine

Brand Names: Prozac, Sarafem, Symbyax

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₈F_₃NO

CAS Number: 54910-89-3

Unique Ingredient Identifier: 01K63SUP8D

Background: Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI). It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.

Indication: Fluoxetine is indicated for both acute and maintenance treatment of major depressive disorder, obsessive compulsive disorder, and bulimia nervosa; however, it is only indicated for acute treatment of panic disorder independent of whether agoraphobia is present. Fluoxetine may also be used in combination with olanzapine to treat depression related to Bipolar I Disorder, and treatment resistant depression. Fluoxetine is additionally indicated for the treatment of female patients with premenstrual dysphoric disorder (PMDD).

Associated Conditions: Alcohol Dependency, Anorexia Nervosa (AN), Bulimia Nervosa, Cataplexy, Depression, Major Depressive Disorder (MDD), Major depressive disorder, recurrent episode, Myoclonus, Obesity, Obsessive Compulsive Disorder (OCD), Panic Disorder With Agoraphobia, Panic disorder without agoraphobia, Premature Ejaculation, Premenstrual Dysphoric Disorder (PMDD)

Associated Therapies: Maintenance therapy

Clinical Trials

Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)

Phase 1

Recruiting

Conditions: Sequestra
Depression

Interventions: Behavioral: GCBT
Drug: Aripiprazole
Drug: Lithium Carbonate
Drug: Fluoxetine
Drug: Sertraline
Drug: Vortioxetine
Drug: Duloxetine
Drug: Olanzapine

First Posted Date: 2023-04-18

Last Posted Date: 2023-08-14

Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

Target Recruit Count: 520

Registration Number: NCT05814640

Locations: 🇨🇳
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Province, China

Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders

Phase 2

Completed

Conditions: Depressive Disorder

Interventions: Drug: Fluoxetine 20 mg
Drug: Dapagliflozin 10mg Tab
Drug: Atorvastatin 80mg

First Posted Date: 2023-03-31

Last Posted Date: 2025-01-03

Lead Sponsor: Tanta University

Target Recruit Count: 75

Registration Number: NCT05792540

Locations: 🇪🇬
Faculty of Medicine, Menoufia University, Tanta, Shebeen El-Kom, Egypt

Clinical Study of Cang Ai Volatile Oil (CAVO) on Mild to Moderate Depression in Children and Adolescents

Early Phase 1

Recruiting

Conditions: Depression

Interventions: Drug: CAVO aromatherapy patch at 3% concentration+Fluoxetine hydrochloride mimetic
Drug: Fluoxetine hydrochloride mimetic+CAVO aromatherapy patch at 0.1% concentration
Drug: Fluoxetine hydrochloride tablet+CAVO aromatherapy patch at 0.1% concentration

First Posted Date: 2023-03-29

Last Posted Date: 2023-03-29

Lead Sponsor: Chen Qian

Target Recruit Count: 108

Registration Number: NCT05789186

Locations: 🇨🇳
Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, China

Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)

Early Phase 1

Recruiting

Conditions: Primary Brain Tumor
Brain Tumor, Recurrent

Interventions: Drug: Fluoxetine
Drug: Temozolomide

First Posted Date: 2022-12-02

Last Posted Date: 2024-11-06

Lead Sponsor: Duke University

Target Recruit Count: 30

Registration Number: NCT05634707

Locations: 🇺🇸
NYU Langone Health, New York, New York, United States
🇺🇸
UC San Diego Moores Cancer Center, San Diego, California, United States
🇺🇸
The Preston Robert Tisch Brain Tumor Center at Duke University, Durham, North Carolina, United States

Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: Prozac® 10 mg capsules
Drug: Fluoxetine 10 mg capsules

First Posted Date: 2022-09-08

Last Posted Date: 2022-09-08

Lead Sponsor: Future University in Egypt

Target Recruit Count: 34

Registration Number: NCT05532332

Locations: 🇪🇬
Future Research Center (FRC), Cairo, Egypt

Fluoxetine Treatment of Depression in Down Syndrome

Phase 4

Completed

Conditions: Down Syndrome
Depression

Interventions: Drug: Fluoxetine

First Posted Date: 2022-07-14

Last Posted Date: 2025-03-30

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 4

Registration Number: NCT05458479

Locations: 🇺🇸
Lurie Center for Autism, Lexington, Massachusetts, United States

Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine

Phase 2

Completed

Conditions: Selective Mutism
Social Anxiety

Interventions: Drug: Fluoxetine

First Posted Date: 2022-05-18

Last Posted Date: 2022-05-18

Lead Sponsor: Michigan State University

Target Recruit Count: 6

Registration Number: NCT05378711

Locations: 🇺🇸
Michigan State University Psychiatry Clinic, East Lansing, Michigan, United States

A Multicenter Clinical Study on Shuganjieyu Capsule Combined With Fluoxetine in the Treatment of Depression

Not Applicable

Conditions: Outpatients / Inpatients With Depression

Interventions: Drug: Shuganjieyu capsule
Drug: Fluoxetine

First Posted Date: 2022-05-04

Last Posted Date: 2022-05-17

Lead Sponsor: Peking University

Target Recruit Count: 160

Registration Number: NCT05361330

Locations: 🇨🇳
Nanjing Brain Hospital, Nanjing Medical University, Nanjing, Jiangsu, China
🇨🇳
First Hospital, Shanxi Medical University, Taiyuan, Shanxi, China
🇨🇳
Institute of Mental Health, Peking University Sixth Hospital, Beijing, China