Adults 18 to 65, any sex, with Bipolar Disorder or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total ScorePrimary· Baseline and 2 hours post-dose for all doses administered over 7 days.
The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).
Dose 1
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
-10.4
± 2.94
Dose 2
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
-10.0
± 3.54
Dose 3
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
-10.1
± 3.60
Dose 4
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
-9.8
± 2.55
Dose 5
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
-11.5
± 4.51
Dose 6
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
-8.7
± 3.79
Dose 7
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
-11.0
± NA
Clinical Global Impression - Improvement (CGI-I)Primary· 2 hours post-dose for all doses administered over 7 days.
The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.
Dose 1
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
1.2
± 0.50
Dose 2
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
1.2
± 0.39
Dose 3
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
1.3
± 0.47
Dose 4
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
1.0
± 0.00
Dose 5
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
1.2
± 0.41
Dose 6
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
1.3
± 0.58
Dose 7
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
2.0
± NA
Number of Participants With Adverse Events During the Follow-up PeriodSecondary· Day 8 through Day 10
Evaluation of withdrawal phenomenon based on the occurrence of adverse events such as tachycardia, systolic hypertension, nausea, or vomiting and the emergence of any new adverse events on ≥2 consecutive days of the 3-day off-treatment follow-up period.
Group
Value
95% CI
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 10 days.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioXcel Therapeutics Inc
Last refreshed: 2 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06041646.