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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07116694
The ClinicalTrials.gov registry entry for NCT07116694 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The listed sponsor is BioXcel Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.
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