Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

Exclusion Criteria

• •1. 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.
• •2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
• •3. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
• •4. Patients who are judged to be at significant risk of suicide.
• •5. Female patients who have a positive pregnancy test at screening or are breastfeeding.
• •6. 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.
• •7. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
• •8. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
• •9. Patients with serious or unstable medical illnesses.
• •10. Patients who have received an investigational drug within 30 days prior to the current agitation episode.
• •11. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.