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

NCT06093451 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-10-23

No results posted yet for this study

Summary

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.

Conditions

  • Schizophrenia Agitation
  • Schizo Affective Disorder
  • Bipolar Disorder
  • Dexmedetomidine

Interventions

DRUG

Dexmedetomidine

Moderate agitation: 120 mcg Severe agitation: 180 mcg

DRUG

Lorazepam 2 MG/ML

2 mg

Sponsors & Collaborators

  • BioXcel Therapeutics Inc

    collaborator INDUSTRY

  • Temple University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-07-01
Completion
2024-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093451 on ClinicalTrials.gov