NCT06093451 is a Phase 4 clinical trial of Dexmedetomidine in Schizophrenia Agitation, sponsored by Temple University.

Who is sponsoring NCT06093451?

NCT06093451 is sponsored by Temple University.

What drugs are being tested in NCT06093451?

Interventions in NCT06093451: Dexmedetomidine, Lorazepam 2 MG/ML.

What condition does NCT06093451 study?

NCT06093451 studies Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder, Dexmedetomidine.

Is NCT06093451 still recruiting?

NCT06093451 is currently status unknown. Last updated 23 October 2023.

Last reviewed 2023-10-23 · How we verify

NCT06093451

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

Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

Status unknown Phase 4 Last updated 23 October 2023

What this trial tests

Phase 4 trial testing Dexmedetomidine in Schizophrenia Agitation in 32 participants. Status unknown.

Timeline

1 July 2023

Primary endpoint
1 July 2024

1 July 2024

Quick facts

Lead sponsor	Temple University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 July 2023
Primary completion	1 July 2024
Estimated completion	1 July 2024
Sites	1 location across United States

Drugs / interventions tested

Dexmedetomidine (dexmedetomidine) — full drug profile →
Lorazepam 2 MG/ML — full drug profile →

Conditions studied

Schizophrenia Agitation — all drugs for Schizophrenia Agitation →
Schizo Affective Disorder — all drugs for Schizo Affective Disorder →
Bipolar Disorder — all drugs for Bipolar Disorder →
Dexmedetomidine — all drugs for Dexmedetomidine →

Sponsor

Temple University

Who can join

Adults 18 to 55, any sex, with Schizophrenia Agitation or Schizo Affective Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Dexmedetomidine

Trials testing the same drug.

NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
NCT07398066 — DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial) · NA · not yet recruiting
NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
NCT07306702 — Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients · Phase 4 · withdrawn
NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting

Other Temple University trials

Trials by the same sponsor.

NCT07055360 — A Trauma-Informed Intervention for the Newly HIV-Diagnosed · NA · not yet recruiting
NCT07277816 — Photo-experiencing and Reflective Listening (PEARL) to Promote Healing Engagement for Survivors of Violence · NA · recruiting
NCT07151768 — Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension · recruiting
NCT07027865 — Sip and Snack Better (SSB) Study: Improving Added Sugar in Adolescents · NA · active not recruiting
NCT06810557 — Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care · NA · 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 NCT06093451 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Temple University
Last refreshed: 23 October 2023

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/NCT06093451.

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