Dibenzothiophene Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials evaluate behavioral and physiological interventions in psychiatric and caregiver populations, targeting conditions such as non-suicidal self-injury, suicide risk, self-harm, emotion regulation, depression, caregiver burden, physical health, and systemic inflammation. Sponsored by academic and medical institutions—including The Catholic University of America, Butler Hospital, and Texas Tech University—these trials carry a phase status of not applicable. Current operational progress across these studies varies, with recruitment statuses designated as either withdrawn or not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05583279	Withdrawn	Non-Suicidal Self Injury\|Suicide\|Self-harm\|Emotion Regulation	The Catholic University of America\|Butler Hospital	2024-02-01	Not Applicable
NCT06055322	Not yet recruiting	Suicide\|Depression\|Caregiver Burden\|Physical Health\|Inflammation	Texas Tech University	2024-01-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dibenzothiophene binds to cytochrome P450 monooxygenases, undergoing oxidative bioactivation that generates reactive intermediate metabolites and disrupts downstream cellular redox pathways. This metabolic transformation induces cellular oxidative stress and alters stress-responsive signaling cascades, modulating pathways associated with clinical conditions such as depression, physical health impairment, and systemic inflammation.

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>).