Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

Inclusion Criteria

• Male and female patients between the ages of 18 to 75 years, inclusive.
• Patients who have met DSM-5 criteria for bipolar I or II disorder.
• Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
• Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
• Patients who read, understand and provide written informed consent.
• Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
• Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria

• Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
• Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
• Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
• Patients who are judged to be at significant risk of suicide.
• Female patients who have a positive pregnancy test at screening or are breastfeeding.
• Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
• History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
• Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
• Patients with serious or unstable medical illnesses.
• Patients who have received an investigational drug within 30 days prior to the current agitation episode.
• Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.