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NCT07116694 · ClinicalTrials.gov registry record · Phase 2
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
A Phase 2 study of Schizophrenia and Schizoaffective Disorder, sponsored by BioXcel Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT07116694: Active Phase 2 study of Schizophrenia and Schizoaffective Disorder, sponsored by BioXcel Therapeutics.
NCT07116694 is a Phase 2 study of Schizophrenia and Schizoaffective Disorder that is active but no longer recruiting, run by BioXcel Therapeutics. The registered enrollment target is 30 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07116694, a Phase 2 study of Schizophrenia and Schizoaffective Disorder, is active but no longer recruiting, sponsored by BioXcel Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
Study Summary
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with Bipolar Disorders, Schizophrenia, Schizoaffective, and Schizophreniform disorders and correlate them with clinician-assessed ratings.
Primary Outcome
The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher
Conditions Studied
Interventions
- DRUG BXCL501 Sublingual Film
Study Locations (5)
California
- BioXcel Clinical Research Site 103 - Chino
- BioXcel Clinical Research Site 105 - Oceanside
- BioXcel Clinical Research Site 102 - Orange
Missouri
- BioXcel Clinical Research Site 101 - St Louis
Nevada
- BioXcel Clinical Research Site 106 - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-06-19 |
| Est. Completion | 2025-10 |
| Phase | Phase 2 |
What the registry record for NCT07116694 still lists
NCT07116694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower).
The record links to 6 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which BXCL501 Sublingual Film is the first listed.
NCT07116694 lists 5 locations in 3 states (California, Missouri, Nevada).
Frequently Asked Questions
What is clinical trial NCT07116694 about?
NCT07116694 is a clinical study titled "Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder". This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with Bipolar Disorders, Schizophrenia, Schizoaffective, and Schizophreniform di...
What is the current status of trial NCT07116694?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-06-19. Estimated completion is 2025-10.
What conditions does trial NCT07116694 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder, Bipolar II Disorder, Schizophreniform Disorders.
What interventions are being tested in trial NCT07116694?
The interventions under investigation include: BXCL501 Sublingual Film (DRUG).
Who is sponsoring clinical trial NCT07116694?
This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07116694 being conducted?
This trial has 5 study locations across California, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07116694's enrollment target sits among peer trials
30 263rd of 315 higher than 49 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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