Clinical Trials

Trazodone has a well-established evaluation profile supported by numerous clinical trials spanning Early Phase I to Phase IV, focusing on major depressive disorder, obstructive sleep apnea, delirium, and treatment-induced sexual dysfunction. Sponsored by academic medical centers, research institutions, and pharmaceutical entities such as Brigham and Women's Hospital and Aziende Chimiche Riunite Angelini Francesco S.p.A., these protocols encompass recruiting, completed, and terminated recruitment statuses. These studies evaluate therapeutic efficacy, safety profiles, and specific endotypic outcomes in both patient cohorts and healthy volunteers.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07542756 RECRUITING
Insomnia; Insomnia Disorder; Chronic Insomnia; Chronic Insomnia Disorder
University of Pennsylvania
 2026-05-01 PHASE4
NCT07136415 RECRUITING
Menopausal Women; Insomnia
Brigham and Women's Hospital
 2026-02-13 PHASE4
NCT04302870 RECRUITING
Motor Neuron Disease, Amyotrophic Lateral Sclerosis
University of Edinburgh
 2020-02-27 PHASE2; PHASE3
NCT07210606 NOT_YET_RECRUITING
Sleep Disordered Breathing; Able Bodied
VA Office of Research and Development
 2026-10-01 PHASE4
NCT07210112 NOT_YET_RECRUITING
Depression - Major Depressive Disorder; Treatment-resistant Depression (TRD)
Centre Hospitalier St Anne
 2025-10-08 PHASE2
NCT05085808 WITHDRAWN
Delirium; Morality; Quality of Life; Psych; Treatment Side Effects
University of Southern California
 2028-03-01 PHASE4
NCT06281756 RECRUITING
Insomnia; Insomnia Chronic; Insomnia, Primary; Blood Pressure; Blood Pressure, High
Milton S. Hershey Medical Center
 2024-03-20 EARLY_PHASE1
NCT05282550 RECRUITING
AMCI - Amnestic Mild Cognitive Impairment; Sleep Disturbance
Johns Hopkins University
 2023-02-02 PHASE2
NCT06983080 RECRUITING
Insomnia Chronic; Older People; Drug Therapy
Centre hospitalier de l'Université de Montréal (CHUM)
 2025-11-10 PHASE2
NCT02922894 RECRUITING
Sleep Apnea; Spinal Cord Injury
John D. Dingell VA Medical Center
 2017-06-09 PHASE4
NCT06740188 RECRUITING
Depressed Insomniac Co-morbid Patients
Tongji University
 2025-01-01 PHASE4
NCT05293600 RECRUITING
Obstructive Sleep Apnea
Brigham and Women's Hospital
 2023-07-01 PHASE1; PHASE2
NCT03668041 COMPLETED
Insomnia
VA Office of Research and Development
 2021-02-25 PHASE3
NCT06286189 RECRUITING
Obstructive Sleep Apnea
Brigham and Women's Hospital
 2024-01-01 PHASE1; PHASE2
NCT06295562 COMPLETED
Obstructive Sleep Apnea of Adult
China Medical University Hospital
 2024-11-05 PHASE4
NCT06546358 UNKNOWN
Postpartum Depression
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2024-09 EARLY_PHASE1
NCT05299398 WITHDRAWN
Postpartum Depression
Verinder Sharma
 2025-04-17 PHASE1
NCT05125146 RECRUITING
Insomnia
Dr. Nazanin Alavi
 2021-11-01
NCT05209035 ACTIVE_NOT_RECRUITING
Mild Cognitive Impairment; Obstructive Sleep Apnea
Chinese University of Hong Kong
 2022-05-10 PHASE4
NCT06773767 COMPLETED
Bioavailability Heathy Volunteers; Bioavailability Study; Bioequivalance
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2024-05-22 PHASE1
NCT04468776 COMPLETED
Chronic Insomnia
California Pacific Medical Center Research Institute
 2022-02-25 PHASE4
NCT06286189 Recruiting
Obstructive Sleep Apnea
Brigham and Women''s Hospital
 2024-01-01 Phase 1|Phase 2
NCT02699138 WITHDRAWN
Sleep Apnea, Obstructive; Post-Traumatic Stress Disorders
University of California, San Diego
 2021-10 EARLY_PHASE1
NCT03534284 COMPLETED
Insomnia; End Stage Renal Disease
University of Washington
 2018-09-19 PHASE3
NCT04082806 COMPLETED
Major Depressive Disorder
Erich Seifritz
 2020-08-06 PHASE2
NCT03852160 WITHDRAWN
Depressive Disorder, Treatment-Resistant
Janssen-Cilag International NV
 2019-12-01 PHASE3
NCT02945644 SUSPENDED
Sleep Apnea, Obstructive
Louis Stokes VA Medical Center
 2017-02-13 PHASE1
NCT05136521 COMPLETED
Healthy
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2020-02-17 PHASE1
NCT03749642 COMPLETED
Painful Diabetic Neuropathy
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2018-11-22 PHASE2
NCT04162743 COMPLETED
Sleep Apnea Syndromes; Cerebral Infarction
Chang Gung Memorial Hospital
 2019-02-01 PHASE4
NCT03522207 TERMINATED
TMD; Sleep Bruxism; TMJ Pain; Chronic Pain; Sleep Disorder
Centre hospitalier de l'Université de Montréal (CHUM)
 2018-10-15 PHASE4
NCT02655354 COMPLETED
Posttraumatic Stress Disorder; Depression; Alcohol-Related Disorders; Suicidal Ideation; Substance-Related Disorders; Mild Cognitive Impairment; Quality of Life; Pain; Wounds and Injury; Brain Injuries; Chronic Disease
University of Washington
 2015-10
NCT02458469 COMPLETED
Spinal Cord Injury; Sleep Disordered Breathing
VA Office of Research and Development
 2015-05-14 PHASE2
NCT03202979 COMPLETED
Painful Diabetic Neuropathy
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2017-05-16 PHASE2
NCT01348542 COMPLETED
Insomnia
Milton S. Hershey Medical Center
 2011-04
NCT02785601 COMPLETED
Depression
Lee's Pharmaceutical Limited
 2017-05-01 PHASE1
NCT02785614 COMPLETED
Depression
Lee's Pharmaceutical Limited
 2017-05-01 PHASE1
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT03516630 COMPLETED
Healthy
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2017-03-20 PHASE1
NCT01651442 COMPLETED
Insomnia Comorbid to Psychiatric Disorder; Primary Insomnia
Jack Edinger, PhD
 2012-08-01
NCT02118688 WITHDRAWN
Delirium; Agitation
Rochester General Hospital
 2011-03 PHASE4
NCT01662297 TERMINATED
Insomnia; Mental Health Disorder; Substance Use Disorder
VA Connecticut Healthcare System
 2012-07 PHASE4
NCT01764867 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
 2012-06 PHASE4
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
 2013-04
NCT02086929 COMPLETED
Major Depressive Disorder
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2012-12 PHASE3
NCT01817907 COMPLETED
Sleep Apnea, Obstructive
Brigham and Women's Hospital
 2013-03
NCT01524497 COMPLETED
Depression
Lee's Pharmaceutical Limited
 2011-11 PHASE2; PHASE3
NCT02086929 Completed
Major Depressive Disorder
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2012-12 Phase 3
NCT01142258 COMPLETED
Sleep; Sleep Disorders; Insomnia; Alzheimer's Disease
Brasilia University Hospital
 2010-03 PHASE3
NCT01097980 COMPLETED
Sexual Dysfunction
Beitou Armed Forces Hospital, Taipei, Taiwan
 2010-04
NCT01400165 UNKNOWN
Healthy
University of Ottawa
 2011-07 PHASE1
NCT00253890 COMPLETED
Poor Quality Sleep; Opiate Addiction
Butler Hospital
 2005-10 PHASE3
NCT01097980 Completed
Sexual Dysfunction
Beitou Armed Forces Hospital Taipei Taiwan
 2010-04 Not Applicable
NCT00791739 COMPLETED
Fibromyalgia
Universidad de Granada
 2008-04 PHASE4
NCT00839072 COMPLETED
Healthy
Labopharm Inc.
 2009-02 PHASE1
NCT01468038 COMPLETED
Sleep Disorder
Targeted Medical Pharma
 2008-04 PHASE3
NCT01121900 COMPLETED
Healthy
Labopharm Inc.
 2008-06 PHASE1
NCT01121926 COMPLETED
Healthy Subjects; Bioavailability; Pharmacokinetics
Labopharm Inc.
 2008-01 PHASE1
NCT00775203 COMPLETED
Major Depressive Disorder
Labopharm Inc.
 2007-06 PHASE3
NCT00027053 COMPLETED
Alcoholism
Rhode Island Hospital
 2002-06 PHASE2
NCT01121913 COMPLETED
Healthy
Labopharm Inc.
 2005-03 PHASE1
NCT00659919 COMPLETED
Schizophrenia
BeerYaakov Mental Health Center
 2000-11 PHASE4
NCT00000179 COMPLETED
Alzheimer Disease
National Institute on Aging (NIA)
 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-05)

Check the Trazodone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trazodone selectively antagonizes 5-HT2A and 5-HT2C serotonin receptors, thereby blocking downstream G-protein-coupled signal transduction pathways and modulating central serotonergic neurotransmission. This receptor inhibition alters neurochemical signaling in the central nervous system, contributing to the therapeutic antidepressant and sedative effects evaluated in clinical trials for major depressive disorder and sleep apnea syndromes.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.