Clinical Trials

Multiple clinical trials evaluating dopamine hydrochloride are currently documented in healthy volunteers and individuals with depression. Encompassing Phase 1 research as well as studies with unassigned phases, these non-recruiting trials are supported by industry sponsors such as AbbVie and academic institutions like University College London. These investigations focus on evaluating dopamine receptor occupancy in the brain and exploring underlying mechanisms in psychiatric health.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06387732 Not yet recruiting
Depression
University College London|King''s College London|Queen Mary University of London|University of Dublin Trinity College
2024-06 Not Applicable
NCT06300580 Not yet recruiting
Healthy Volunteers
AbbVie
2024-05-03 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dopamine hydrochloride binds to and activates dopamine D1 through D5 receptors as well as adrenergic beta-1 and alpha receptors, initiating downstream G-protein-coupled signaling cascades that modulate central neurotransmission and vascular tone. This receptor activation alters neural circuit dynamics and cardiovascular responsiveness, providing the functional basis for evaluating cerebral receptor occupancy in healthy volunteers and investigating neurobiological pathways in depression.

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>).

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