NCT00866645 is a Phase 2/Phase 3 clinical trial of Intramuscular Haloperidol in Agitation, sponsored by Shanghai Mental Health Center.

Who is sponsoring NCT00866645?

NCT00866645 is sponsored by Shanghai Mental Health Center.

What drugs are being tested in NCT00866645?

Interventions in NCT00866645: Intramuscular Haloperidol, Intramuscular Levosulpiride.

Is NCT00866645 still recruiting?

NCT00866645 is currently completed. Last updated 2 December 2010.

Last reviewed 2010-12-02 · How we verify

NCT00866645

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Blind Parallel Intramuscular Haloperidol-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Intramuscular Levosulpiride in the Treatment of Chinese Patients With Agitation Of Schizophrenia

Completed Phase 2/Phase 3 Last updated 2 December 2010

What this trial tests

Phase 2/Phase 3 trial testing Intramuscular Haloperidol in Agitation in 240 participants. Completed in 1 July 2010.

Timeline

1 February 2009

Primary endpoint
1 July 2010

1 July 2010

Quick facts

Lead sponsor	Shanghai Mental Health Center
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	240
Start date	1 February 2009
Primary completion	1 July 2010
Estimated completion	1 July 2010
Sites	5 locations across China

Drugs / interventions tested

Intramuscular Haloperidol — full drug profile →
Intramuscular Levosulpiride — full drug profile →

Conditions studied

Agitation — all drugs for Agitation →

Sponsor

Shanghai Mental Health Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Agitation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

the change of PANSS-EC total scores
Time frame: from baseline to the end of study(72 hours after first dosing)

Sponsor's own description

The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from baseline.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Haloperidol for psychosis-induced aggression or agitation (rapid tranquillisation).
Ostinelli EG, Brooke-Powney MJ, Li X, Adams CE. · · 2017 · cited 38× · PMID 28758203 · DOI 10.1002/14651858.cd009377.pub3

Verify or expand the search:

Other recruiting trials for Agitation

Currently open trials in the same condition.

NCT06937229 — A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) · Phase 3 · recruiting
NCT05522647 — Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients. · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting

Other Shanghai Mental Health Center trials

Trials by the same sponsor.

NCT07480408 — Neural Mechanisms of the Sensorymotor Circuit in Sensory Phenomena in OCD · NA · not yet recruiting
NCT07479771 — tTIS Targeted of the Striatum as an Intervention for MUD Patients · NA · not yet recruiting
NCT07472673 — Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Pati · NA · not yet recruiting
NCT07484750 — Efficacy and Influencing Factors of Mindfulness-Based Exposure Group Therapy for OCD · NA · recruiting
NCT07311655 — Validation of the Accuracy of an AI-Based System for Diagnosing Anxiety Disorders · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00866645 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Mental Health Center
Last refreshed: 2 December 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00866645.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing