Trazodone HCl Clinical Trials

Size	Price	Qty
50mg	USD 70
100mg	USD 99

Clinical Trials

Multiple clinical trials evaluate the therapeutic efficacy of trazodone hydrochloride across indications including obstructive sleep apnea, major depressive disorder, and selective serotonin reuptake inhibitor-induced sexual dysfunction. Spanning Phase 1/Phase 2, Phase 3, and Not Applicable classifications, these studies are reported as completed or actively recruiting. Research sponsors include academic institutions and pharmaceutical entities, specifically Brigham and Women's Hospital, Aziende Chimiche Riunite Angelini Francesco S.p.A., and Beitou Armed Forces Hospital.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06286189	Recruiting	Obstructive Sleep Apnea	Brigham and Women''s Hospital	2024-01-01	Phase 1\|Phase 2
NCT02086929	Completed	Major Depressive Disorder	Aziende Chimiche Riunite Angelini Francesco S.p.A	2012-12	Phase 3
NCT01097980	Completed	Sexual Dysfunction	Beitou Armed Forces Hospital Taipei Taiwan	2010-04	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trazodone hydrochloride acts predominantly as a serotonin receptor antagonist, binding target receptors such as 5-HT2A with a Ki of 13 nM to block downstream serotonergic signaling pathways. This inhibition reduces central neuronal excitability and alters neurotransmitter dynamics, providing clinical relevance in the management of major depressive disorder, obstructive sleep apnea, and anxiety.

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>).