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

Effects of Three Single Oral Doses of Trazodone on the QTc Interval Duration in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2018-05-04
Last Posted Date
2020-07-31
Lead Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Target Recruit Count
20
Registration Number
NCT03516630
Locations
🇨🇭

CROSS Research S.A., Phase I Unit,, Arzo, Switzerland

Trazodone in Painful Diabetic Neuropathy

Phase 2
Completed
Conditions
Painful Diabetic Neuropathy
Interventions
First Posted Date
2017-06-29
Last Posted Date
2018-09-28
Lead Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Target Recruit Count
142
Registration Number
NCT03202979
Locations
🇵🇱

NZOZ Neuromed M. i M. Nastaj Sp. P., Lublin, Poland

🇵🇱

RCMed Oddział Sochaczew, Sochaczew, Poland

🇵🇱

NBR Polska Tomasz Klodawski, Warszawa, Poland

and more 17 locations

Trazodone Dose Tolerance and APAP Adherence

Phase 1
Suspended
Conditions
Sleep Apnea, Obstructive
Interventions
Drug: Placebo
First Posted Date
2016-10-26
Last Posted Date
2020-05-11
Lead Sponsor
Louis Stokes VA Medical Center
Target Recruit Count
45
Registration Number
NCT02945644
Locations
🇺🇸

Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio, United States

Treatment of Sleep Apnea in Patients with Cervical Spinal Cord Injury

Phase 4
Recruiting
Conditions
Sleep Apnea
Spinal Cord Injury
Interventions
Procedure: Acute episodic hypoxia
Procedure: Supplemental oxygen
Procedure: Sham
Drug: Placebo
First Posted Date
2016-10-04
Last Posted Date
2025-03-28
Lead Sponsor
John D. Dingell VA Medical Center
Target Recruit Count
100
Registration Number
NCT02922894
Locations
🇺🇸

John D. Dingell VA Medical Center, Detroit, Michigan, United States

PK Study of Diet Effect of Trazodone Hydrochloride Prolonged-Released Tablets in Healthy Chinese

Phase 1
Completed
Conditions
Depression
Interventions
First Posted Date
2016-05-30
Last Posted Date
2018-09-05
Lead Sponsor
Lee's Pharmaceutical Limited
Target Recruit Count
15
Registration Number
NCT02785601
Locations
🇭🇰

Prince of Wales Hospital, Hong Kong, Hong Kong

PK Study of Multi-dose Trazodone Hydrochloride Prolonged-released Tablets in Healthy Chinese

First Posted Date
2016-05-30
Last Posted Date
2018-09-05
Lead Sponsor
Lee's Pharmaceutical Limited
Target Recruit Count
12
Registration Number
NCT02785614
Locations
🇭🇰

Phase I Clinical Trial Centre, Chinese University of Hong Kong, Hong Kong, Sha Tin New Territories, Hong Kong

Obstructive Sleep Apnea and Arousal Threshold in Patients With Post-traumatic Stress Disorder

Early Phase 1
Withdrawn
Conditions
Sleep Apnea, Obstructive; Post-Traumatic Stress Disorders
Interventions
Drug: Placebo
Device: Epiglottic catheter
First Posted Date
2016-03-04
Last Posted Date
2019-07-10
Lead Sponsor
University of California, San Diego
Registration Number
NCT02699138
Locations
🇺🇸

University of California San Diego, San Diego, California, United States

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

Not Applicable
Completed
Conditions
Depression
Posttraumatic Stress Disorder
Mild Cognitive Impairment
Alcohol-Related Disorders
Substance-Related Disorders
Wounds and Injury
Suicidal Ideation
Brain Injuries
Quality of Life
Chronic Disease
Interventions
First Posted Date
2016-01-14
Last Posted Date
2021-07-02
Lead Sponsor
University of Washington
Target Recruit Count
635
Registration Number
NCT02655354
Locations
🇺🇸

Jacobi Medical Center, Bronx, New York, United States

🇺🇸

University of Rochester, Rochester, New York, United States

🇺🇸

Honor Health, Scottsdale, Arizona, United States

and more 21 locations

Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

Phase 2
Completed
Conditions
Spinal Cord Injury
Sleep Disordered Breathing
Interventions
First Posted Date
2015-06-01
Last Posted Date
2021-06-14
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
15
Registration Number
NCT02458469
Locations
🇺🇸

John D. Dingell VA Medical Center, Detroit, MI, Detroit, Michigan, United States

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