Clinical Trials Logo

Clinical Trial Summary

This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.


Clinical Trial Description

The study will enroll approximately 120 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo. Subjects with acute agitation will include male and female children and adolescents who are either newly admitted to a hospital setting or already admitted and experiencing acute agitation. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05025605
Study type Interventional
Source BioXcel Therapeutics Inc
Contact Lisa Hemsen
Phone 475-25-5899
Email [email protected]
Status Recruiting
Phase Phase 1
Start date August 27, 2021
Completion date June 24, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Not yet recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Active, not recruiting NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 1/Phase 2
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Not yet recruiting NCT04005794 - Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training N/A
Not yet recruiting NCT04580134 - Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine) Phase 4
Recruiting NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Recruiting NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Completed NCT01412060 - A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia Phase 3
Completed NCT01222793 - Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia N/A