Haloperidol Decanoate Clinical Trials

Size	Price	Qty
1mg	USD 129
5mg	USD 390

Clinical Trials

A clinical trial sponsored by the Central Mental Clinic for Outpatients of Baku City evaluated adjunctive lamotrigine combined with haloperidol decanoate in patients suffering from resistant schizophrenia characterized by persistent verbal hallucinations. This Phase IV study focused on combination therapeutic approaches in schizophrenia management, though its recruitment status is reported as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00947375	Terminated	Schizophrenia	Central Mental Clinic for Outpatients of Baku City	2005-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Haloperidol decanoate functions as a depot prodrug that slowly releases haloperidol to selectively bind and antagonize central dopamine D2 receptors, thereby blocking downstream G-protein-coupled signaling and reducing dopaminergic neurotransmission. This inhibition of hyperactive mesolimbic dopamine pathways decreases postsynaptic neuronal excitability, providing the cellular mechanism for controlling psychotic symptoms in conditions such as schizophrenia.

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>).