Duloxetine

Generic Name: Duloxetine

Brand Names: Cymbalta, Drizalma, Irenka, Yentreve, Duloxetine Zentiva, Duloxetine Mylan, Duloxetine Lilly

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₁₉NOS

CAS Number: 116539-59-4

Unique Ingredient Identifier: O5TNM5N07U

Background: Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor. It was originally discovered in 1993 and developed by Eli Lilly and Company as LY248686. Duloxetine first received approval from the FDA in August, 2004 as Cymbalta for the treatment of Major Depressive Disorder. It has since received approval for a variety of indications including the treatment of neuropathic pain, Generalized Anxiety disorder, osteoarthritis, and stress incontinence. Duloxetine continues to be investigated for the treatment of pain in cancer, surgery, and more.

Indication: Indicated for:

1) Management of Major Depressive Disorder.

2) Management of Generalized Anxiety Disorder.

3) Management of diabetic peripheral neuropathy.

4) Management of fibromyalgia.

5) Management of chronic musculoskeletal pain.

6) Management of osteoarthritis of the knee in adults.

7) Management of chronic lower back pain in adults.

8) Management of stress urinary incontinence in adult women.

Off-label uses include:

1) Management of chemotherapy-induced peripheral neuropathy.

2) Management of stress urinary incontinence in adult men after prostatectomy until recovery is complete.

Associated Conditions: Chronic Lower Back Pain (CLBP), Chronic Musculoskeletal Pain, Diabetic Peripheral Neuropathic Pain (DPN), Fibromyalgia, Generalized Anxiety Disorder, Major Depressive Disorder (MDD), Osteoarthritis of the Knee, Stress Urinary Incontinence (SUI)

Associated Therapies: -

Clinical Trials

A Study in Depression and Associated Painful Physical Symptoms

Phase 4

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Placebo
Drug: Duloxetine

First Posted Date: 2010-02-18

Last Posted Date: 2012-02-13

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 527

Registration Number: NCT01070329

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., San Juan, Puerto Rico

Therapeutic Drug Monitoring in Child and Adolescent Psychiatry

Completed

Conditions: Anorexia Nervosa
Depression
ADHD

Interventions: Drug: Olanzapine
Drug: Atomoxetine
Drug: Duloxetine
Drug: Aripiprazole

First Posted Date: 2010-01-27

Last Posted Date: 2019-03-06

Lead Sponsor: Medical University of Vienna

Target Recruit Count: 200

Registration Number: NCT01057329

Locations: 🇦🇹
Medical University of Vienna, Vienna, Austria

A Study of the Neurobiology of Depression

Phase 4

Completed

Conditions: Healthy Participants
Major Depressive Disorder

Interventions: Drug: Duloxetine

First Posted Date: 2010-01-18

Last Posted Date: 2014-10-10

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 60

Registration Number: NCT01051466

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., London, United Kingdom

Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome

Phase 4

Completed

Conditions: Major Depressive Disorder
Pain
Soft Tissue Discomfort Syndrome

Interventions: Drug: Duloxetine

First Posted Date: 2009-12-18

Last Posted Date: 2020-04-16

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 22

Registration Number: NCT01035073

Locations: 🇺🇸
Depression Research Unit, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, United States

Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Drug: Duloxetine

First Posted Date: 2009-12-09

Last Posted Date: 2013-08-08

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 35

Registration Number: NCT01028352

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis

Phase 3

Completed

Conditions: Osteoarthritis Knee Pain

Interventions: Drug: Placebo
Drug: Duloxetine

First Posted Date: 2009-11-25

Last Posted Date: 2012-10-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 524

Registration Number: NCT01018680

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., San Juan, Puerto Rico

A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms

Phase 4

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Duloxetine
Drug: Placebo

First Posted Date: 2009-10-23

Last Posted Date: 2012-01-13

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 528

Registration Number: NCT01000805

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., Stockholm, Sweden

Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)

Phase 1

Completed

Conditions: Mood Disorder
Substance-Related Disorders
Amphetamine-Related Disorders

Interventions: Drug: 3,4-Methylenedioxymethamphetamine
Drug: Duloxetine
Drug: Placebo

First Posted Date: 2009-10-06

Last Posted Date: 2013-01-25

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 16

Registration Number: NCT00990067

Locations: 🇨🇭
Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland

Effects of Gastric Bypass on Blood Levels of Duloxetine

Phase 3

Completed

Conditions: Bariatric Surgery

Interventions: Drug: Duloxetine

First Posted Date: 2009-10-02

Last Posted Date: 2014-08-11

Lead Sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota

Target Recruit Count: 20

Registration Number: NCT00989157

Locations: 🇺🇸
Neuropsychiatric Research Institute, Fargo, North Dakota, United States

A Study of Patients With Major Depressive Disorder and Residual Apathy

Phase 4

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Duloxetine
Drug: Escitalopram

First Posted Date: 2009-09-28

Last Posted Date: 2011-12-13

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 483

Registration Number: NCT00985504

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., Tao-Yuan, Taiwan

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