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CompletedNCT04276883

Dexmedetomidine for Agitation in Bipolarity

About this title

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

Read the official source — NCT04276883

Researchers compared Sublingual film containing Dexmedetomidine (BXCL501) and placebo to find out how the approaches affected psychotic symptoms in people with bipolarity.

Medication studyAges 18–75United States
The study in practice

Understand this study

What did researchers investigate?

Researchers compared Sublingual film containing Dexmedetomidine (BXCL501) and placebo to find out how the approaches affected psychotic symptoms in people with bipolarity.

Who was this study for?

This study was for people with bipolarity. Listed age limits: 18 years to 75 years. Other eligibility criteria applied.

Listed locations
Little Rock and 14 more locationsSee all locations and recruitment
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.

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Study clarity

Study information

Study start dateStarted: February 24, 2020
Recruitment status
Completed
Enrollment listed in the registry
380
Sponsor
BioXcel Therapeutics Inc
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States
Age range
From 18 Years to 75 Years
Official registry ID
NCT04276883
Official title
Show the full official title

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of BXCL501 In Agitation Associated With Bipolar Disorder

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Recruitment & locations

Completed

Little Rock · Cerritos · Culver City

12 more locations
  • Long Beach
  • Orange
  • Miami Lakes
  • Chicago
  • Gaithersburg
  • Las Vegas
  • Berlin
  • Marlton
  • Charleston
  • Austin
  • DeSoto
  • Richardson

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FAQ

Questions about this study

What did researchers investigate?

Researchers compared Sublingual film containing Dexmedetomidine (BXCL501) and placebo to find out how the approaches affected psychotic symptoms in people with bipolarity.

Who is behind this study?

The study sponsor is BioXcel Therapeutics Inc.

Did this study involve medication?

Yes. The study involved medication, including Sublingual film containing Dexmedetomidine (BXCL501) and Placebo Film.

Who was this study for?

This study was for people with bipolarity. Listed age limits: 18 years to 75 years. Other eligibility criteria applied.

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