Vilazodone HCl Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Numerous clinical trials evaluate the therapeutic profile and clinical utility of vilazodone, focusing primarily on major depressive disorder, anxiety, social anxiety disorder, post-traumatic stress disorder, menopausal hot flushes, and antidepressant-associated sexual dysfunction. Spanning Phase 1 pharmacology through Phase 4 studies, these trials are sponsored by pharmaceutical companies such as Forest Laboratories alongside academic institutions including Massachusetts General Hospital and Duke University. Although many studies are completed, others encompass active recruitment, terminated, or withdrawn statuses across diverse cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05422612	SUSPENDED	Post Traumatic Stress Disorder	Global Coalition for Adaptive Research	2023-11-02	PHASE2
NCT05948579	NOT_YET_RECRUITING	Post Traumatic Stress Disorder	Global Coalition for Adaptive Research	2027-08	PHASE2
NCT02372799	COMPLETED	Major Depressive Disorder	Forest Laboratories	2015-02-28	PHASE3
NCT02436239	COMPLETED	Major Depressive Disorder	Forest Laboratories	2015-05-02	PHASE3
NCT01999920	COMPLETED	Separation Anxiety Disorder	New York State Psychiatric Institute	2013-12	PHASE4
NCT01856127	TERMINATED	Sexual Dysfunction; Major Depressive Disorder	Thomas Jefferson University	2013-01	PHASE4
NCT01878292	COMPLETED	Major Depressive Disorder	Forest Laboratories	2013-07-11	PHASE3
NCT01742832	COMPLETED	Major Depressive Disorder	University of Chicago	2013-05	PHASE2
NCT01715519	COMPLETED	PTSD; Depression	Southern California Institute for Research and Education	2012-10	PHASE4
NCT01608295	COMPLETED	Major Depressive Disorder	University of California, Los Angeles	2012-07	PHASE4
NCT01574183	COMPLETED	Marijuana Dependence	Medical University of South Carolina	2012-08	PHASE2
NCT02028026	WITHDRAWN	Major Depressive Disorder; Anxiety; Comorbidity	Massachusetts General Hospital	2013-04	PHASE4
NCT01573598	COMPLETED	Major Depressive Disorder	Forest Laboratories	2012-04	PHASE4
NCT02097147	COMPLETED	Healthy	Forest Laboratories	2014-03	PHASE1
NCT01828515	COMPLETED	Memory Impairment	University of Texas Southwestern Medical Center	2012-12	PHASE2
NCT01844115	COMPLETED	Generalized Anxiety Disorder	Forest Laboratories	2013-04-30	PHASE3
NCT01712321	UNKNOWN	Social Anxiety Disorder	The Medical Research Network	2012-10
NCT01629966	COMPLETED	Generalized Anxiety Disorder	Forest Laboratories	2012-06-30	PHASE3
NCT02015546	COMPLETED	Major Depressive Disorder (MDD)	Duke University	2012-12	PHASE3
NCT01680900	COMPLETED	Hot Flushes	University of Pennsylvania	2012-11
NCT01473381	COMPLETED	Major Depressive Disorder	Forest Laboratories	2011-12	PHASE4
NCT01473394	COMPLETED	Major Depressive Disorder	Forest Laboratories	2011-12	PHASE4
NCT00644358	COMPLETED	Major Depressive Disorder	Forest Laboratories	2007-12-31	PHASE3
NCT00683592	COMPLETED	Major Depressive Disorder	Forest Laboratories	2008-03	PHASE3
NCT00285376	COMPLETED	Depressive Disorder, Major	Genaissance Pharmaceuticals	2006-02	PHASE3
NCT00290914	COMPLETED	Major Depressive Disorder	Pharmacology Research Institute		PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vilazodone HCl selectively binds to the serotonin transporter to inhibit neuronal serotonin reuptake while concurrently acting as a partial agonist at presynaptic and postsynaptic 5-HT1A receptors, thereby elevating synaptic serotonin availability within central neural pathways. This potentiation of serotonergic signaling restores central neurochemical equilibrium and promotes affective stabilization, driving its therapeutic utility in managing major depressive disorder and associated anxiety disorders evaluated in clinical trials.

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>).