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

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Phase 3

Recruiting

Conditions: Depressive Disorder, Major

Interventions: Drug: Fluoxetine
Drug: Placebo
Drug: Roflumilast

First Posted Date: 2025-03-06

Last Posted Date: 2025-03-18

Lead Sponsor: Tanta University

Target Recruit Count: 60

Registration Number: NCT06860958

Locations: 🇪🇬
Tanta Unuversity, Tanta, Egypt

Fluoxetine for Refractory Constipation

Not Applicable

Completed

Conditions: Refractory Constipation

Interventions: Drug: Fluoxetine
Drug: Polyethylene Glycol 400 0.4%

First Posted Date: 2024-12-27

Last Posted Date: 2024-12-27

Lead Sponsor: Zhifeng Zhao, PhD

Target Recruit Count: 316

Registration Number: NCT06750445

Locations: 🇨🇳
People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China
🇨🇳
The First Affiliated Hospital of the Fourth Military Medical University, Xi'an, Shaanxi, China
🇨🇳
Xi'an International Medical Center Hospital, Xi'an, Shaanxi, China

Evaluation of Fluoxetine in Refractory Constipation With Comorbid Anxiety and Depression Treatment

Phase 1

Not yet recruiting

Conditions: Refractory Constipation

Interventions: Drug: Fluoxetine
Drug: Placebo

First Posted Date: 2024-07-17

Last Posted Date: 2025-05-13

Lead Sponsor: Zhifeng Zhao, PhD

Target Recruit Count: 194

Registration Number: NCT06506136

Locations: 🇨🇳
People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China
🇨🇳
Xi'an International Medical Center Hospital, Xi'an, Shaanxi, China

The Friendship Bench Plus Trial: A Randomised Control Trial

Not Applicable

Not yet recruiting

Conditions: Major Depressive Disorder
Severe Depressive Episode Without Psychotic Symptoms

Interventions: Behavioral: Friendship Bench Intervention- Problem Solving Therapy
Drug: Fluoxetine
Drug: Sertraline Pill

First Posted Date: 2024-04-25

Last Posted Date: 2025-05-02

Lead Sponsor: University of Bern

Target Recruit Count: 296

Registration Number: NCT06384209

Locations: 🇿🇼
University of Zimbabwe, Harare, Zimbabwe

Fluoxetine in KCNC1-related Disorder

Not Applicable

Conditions: Genetic Disease
Rare Diseases
KCNC1 Related Disorder

Interventions: Drug: Fluoxetine

First Posted Date: 2024-04-02

Last Posted Date: 2024-04-02

Lead Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Target Recruit Count: 1

Registration Number: NCT06341127

Locations: 🇨🇦
Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada

Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer

Phase 1

Recruiting

Conditions: Colorectal Adenocarcinoma

Interventions: Drug: Fluoxetine

First Posted Date: 2024-01-25

Last Posted Date: 2025-05-13

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 10

Registration Number: NCT06225011

Locations: 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Recruiting

Conditions: Brain Connectivity
Constipation - Functional
Somatic Symptom
Mental Symptom
Fluoxetine
Treatment Efficacy
Refractory Constipation
fMRI

Interventions: Diagnostic Test: BOLD-fMRI
Drug: Regular treatment of functional constipation
Drug: fluoxetine

First Posted Date: 2024-01-24

Last Posted Date: 2024-01-30

Lead Sponsor: Xijing Hospital of Digestive Diseases

Target Recruit Count: 150

Registration Number: NCT06221722

Locations: 🇨🇳
People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China
🇨🇳
Xi'an International Medical Center Hospital, Xi'an, Shaanxi, China
🇨🇳
Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China