MedPath

Fluoxetine

Generic Name
Fluoxetine
Brand Names
Prozac, Sarafem, Symbyax
Drug Type
Small Molecule
Chemical Formula
C17H18F3NO
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

Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients

Phase 4
Completed
Conditions
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Interventions
First Posted Date
2013-12-30
Last Posted Date
2022-09-09
Lead Sponsor
Shanghai Mental Health Center
Target Recruit Count
78
Registration Number
NCT02022709
Locations
🇨🇳

Shanghai Mental Health Center, Shanghai, Shanghai, China

An Adaptive Treatment Strategy for Adolescent Depression-Continuation

Phase 1
Completed
Conditions
Adolescent Depression
Interventions
Drug: Fluoxetine
Behavioral: Interpersonal Psychotherapy
First Posted Date
2013-12-20
Last Posted Date
2020-03-23
Lead Sponsor
University of Minnesota
Target Recruit Count
15
Registration Number
NCT02017535
Locations
🇺🇸

University of Minnesota, Department of Psychiatry, Minneapolis, Minnesota, United States

A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2013-10-23
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
28
Registration Number
NCT01967979

RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke

Phase 2
Withdrawn
Conditions
Severe Stroke With Affected Arm Motor Function
Interventions
Drug: Fluoxetine
Drug: Placebo
Procedure: Usual Care
Procedure: eCMIT
First Posted Date
2013-10-16
Last Posted Date
2015-01-12
Lead Sponsor
University of Alabama at Birmingham
Registration Number
NCT01963832
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial

Phase 2
Completed
Conditions
Secondary Progressive Multiple Sclerosis
Interventions
First Posted Date
2013-07-29
Last Posted Date
2020-03-26
Lead Sponsor
University College, London
Target Recruit Count
445
Registration Number
NCT01910259
Locations
🇬🇧

Gartnavel Royal Hospital, 1055 Great Western Road, Glasgow, United Kingdom

🇬🇧

The Walton Centre, Liverpool, United Kingdom

🇬🇧

Derriford Hospital, Plymouth, United Kingdom

and more 10 locations

Interpersonal Psychotherapy for Treatment Resistant Depression

First Posted Date
2013-07-11
Last Posted Date
2013-07-11
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
74
Registration Number
NCT01896349
Locations
🇧🇷

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil

Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression

Phase 4
Completed
Conditions
Major Depression
Interventions
First Posted Date
2013-04-04
Last Posted Date
2017-09-14
Lead Sponsor
Capital Medical University
Target Recruit Count
189
Registration Number
NCT01824433
Locations
🇨🇳

Beijing Anding Hospital, Beijing, Beijing, China

A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2013-03-11
Last Posted Date
2015-11-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
200
Registration Number
NCT01808651
Locations
🇯🇵

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tokyo, Japan

A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
Drug: Fluoxetine
First Posted Date
2013-03-11
Last Posted Date
2015-05-12
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
513
Registration Number
NCT01808612
Locations
🇯🇵

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tokyo, Japan

An Adaptive Treatment Strategy for Adolescent Depression

Phase 1
Completed
Conditions
Adolescent Depression
Interventions
Drug: Fluoxetine
Behavioral: Increased Dose of Interpersonal Psychotherapy
Behavioral: Continue to Receive Initial Dose of Interpersonal Psychotherapy
First Posted Date
2013-03-01
Last Posted Date
2019-07-11
Lead Sponsor
University of Minnesota
Target Recruit Count
40
Registration Number
NCT01802437
Locations
🇺🇸

University of Minnesota, Department of Psychiatry, Minneapolis, Minnesota, United States

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