Sulpiride Clinical Trials

Size	Price	Qty
100mg	USD 147
500mg	USD 347

Clinical Trials

Multiple clinical trials investigate sulpiride's therapeutic utility and pharmacological mechanisms across psychiatric and neurological conditions—such as schizophrenia, depression, anxiety disorders, and dementia—alongside applications in bowel preparation and ocular physiology. These protocols encompass Phase 3, Phase 4, and non-applicable phase neuroimaging studies focused on antipsychotic intervention efficacy and dopaminergic cognitive mechanisms. Sponsored primarily by academic institutions including Damanhour University, Central South University, and Hannover Medical School, trial recruitment statuses range from completed and unknown to terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05208294	COMPLETED	Placebo Effect on Mood Improvement	Philipps University Marburg	2021-12-09
NCT05884671	COMPLETED	Sulpiride's Effect on Striatal BOLD Signal During Working Memory Gating; Interaction of Sulpiride, Average Reward Rate and Evidence Accumulation; Interaction of Sulpiride, Average Reward Rate and Cognitive Effort	Donders Centre for Cognitive Neuroimaging	2021-09-23
NCT04583111	UNKNOWN	Bowel Preparation	RenJi Hospital	2020-03-01	PHASE4
NCT02749747	COMPLETED	Menopausal Syndrome; Hot Flashes	Hospital de Clinicas de Porto Alegre	2014-06	PHASE3
NCT02374567	TERMINATED	Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders	Hannover Medical School	2015-01	PHASE3
NCT02307396	COMPLETED	Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders	Technical University of Munich	2015-02-01	PHASE4
NCT01896349	UNKNOWN	Treatment Resistant Depression	Hospital de Clinicas de Porto Alegre	2013-04
NCT01777685	Completed	Healthy	Damanhour University	2013-01	Not Applicable
NCT01777685	COMPLETED	Healthy	Damanhour University	2013-01
NCT01615185	TERMINATED	Schizophrenia	Kaohsiung Kai-Suan Psychiatric Hospital	2008-01	PHASE4
NCT00654576	COMPLETED	Schizophrenia	Central South University	2005-02	PHASE4
NCT00280501	COMPLETED	Regional Blood Flow; Ocular Physiology	Medical University of Vienna	2005-08

(data from https://clinicaltrials.gov, updated on 2024-01-16)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sulpiride selectively binds to and antagonizes dopamine D2 receptors, thereby inhibiting G-protein-coupled downstream signaling pathways and reducing dopaminergic neurotransmission. This receptor blockade modulates central neural circuitry and peripheral signaling, which underlies its therapeutic relevance in managing clinical conditions such as schizophrenia, depression, and gastrointestinal motility disorders.

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>).