MedPath

Trazodone

Generic Name
Trazodone
Brand Names
Desyrel, Oleptro
Drug Type
Small Molecule
Chemical Formula
C19H22ClN5O
CAS Number
19794-93-5
Unique Ingredient Identifier
YBK48BXK30
Background

Trazodone is triazolopyridine derivative from the serotonin receptor antagonists and reuptake inhibitors (SARIs) class of antidepressants. It is used in adults and has been shown to be comparable in efficacy to other drugs such as tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and serotonin-norepinephrine receptor inhibitor (SNRIs) in the treatment of depression. A unique feature of this drug is that it does not promote the anxiety symptoms, sexual symptoms, or insomnia, which are commonly associated with SSRI and SNRI therapy. Trazodone acts on various receptors, including certain histamine, serotonin, and adrenergic receptors, distinguishing it from other antidepressants that cover a narrow range of neurotransmitters. It was initially granted FDA approval in 1981.

Indication

Trazodone is indicated for the treatment of major depressive disorder (MDD). It has been used off-label for adjunct therapy in alcohol dependence, and off-label to treat anxiety and insomnia. It may also be used off-label to treat symptoms of dementia, Alzheimer’s disease, schizophrenia, eating disorders, and fibromyalgia due to its effects on various neurotransmitter receptors.

Associated Conditions
Alcohol Dependency, Alzheimer's Disease (AD), Anxiety, Dementia, Eating Disorders Symptoms, Fibromyalgia, Insomnia, Major Depressive Disorder (MDD), Pain, Inflammatory, Schizophrenia, Moderate to severe pain

Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations

Phase 1
Conditions
Healthy
Interventions
First Posted Date
2011-07-22
Last Posted Date
2011-07-22
Lead Sponsor
University of Ottawa
Target Recruit Count
30
Registration Number
NCT01400165
Locations
🇨🇦

University of Ottawa, Institute of Mental Health Research, Ottawa, Ontario, Canada

Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Not Applicable
Completed
Conditions
Insomnia
Interventions
Behavioral: Cognitive Behavioral Therapy
First Posted Date
2011-05-05
Last Posted Date
2020-02-25
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
24
Registration Number
NCT01348542
Locations
🇺🇸

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Trazodone for Sleep Disorders in Alzheimer's Disease

Phase 3
Completed
Conditions
Sleep
Sleep Disorders
Insomnia
Alzheimer's Disease
Interventions
Drug: Placebo
First Posted Date
2010-06-11
Last Posted Date
2012-10-15
Lead Sponsor
Brasilia University Hospital
Target Recruit Count
40
Registration Number
NCT01142258
Locations
🇧🇷

Geriatric Medical Centre, Brasilia, Distrito Federal, Brazil

A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State

Phase 1
Completed
Conditions
Healthy Subjects
Bioavailability
Pharmacokinetics
Interventions
First Posted Date
2010-05-12
Last Posted Date
2012-04-30
Lead Sponsor
Labopharm Inc.
Target Recruit Count
30
Registration Number
NCT01121926

Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-12
Last Posted Date
2012-04-27
Lead Sponsor
Labopharm Inc.
Target Recruit Count
24
Registration Number
NCT01121913

A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily)

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-12
Last Posted Date
2012-04-27
Lead Sponsor
Labopharm Inc.
Target Recruit Count
26
Registration Number
NCT01121900

Trazodone for SSRI-sexual Dsyfunction

Not Applicable
Completed
Conditions
Sexual Dysfunction
Interventions
Drug: Placebo
First Posted Date
2010-04-02
Last Posted Date
2012-04-24
Lead Sponsor
Beitou Armed Forces Hospital, Taipei, Taiwan
Target Recruit Count
56
Registration Number
NCT01097980
Locations
🇨🇳

Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan

Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-09
Last Posted Date
2012-04-27
Lead Sponsor
Labopharm Inc.
Target Recruit Count
24
Registration Number
NCT00839072
Locations
🇨🇦

Algorithme Pharma Inc., Laval, Quebec, Canada

A Randomized, Double-blind, Two-arm Study Comparing the Efficacy and Safety of Trazodone Contramid® OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder.

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2008-10-20
Last Posted Date
2012-04-27
Lead Sponsor
Labopharm Inc.
Target Recruit Count
412
Registration Number
NCT00775203

Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

Phase 4
Completed
Conditions
Schizophrenia
Interventions
Drug: Placebo
First Posted Date
2008-04-17
Last Posted Date
2008-06-17
Lead Sponsor
BeerYaakov Mental Health Center
Target Recruit Count
13
Registration Number
NCT00659919
Locations
🇮🇱

Beer Yaakov MHC, Beer Yaacov, Israel

© Copyright 2025. All Rights Reserved by MedPath