Bipolar disorder is a mental health condition that affects an estimated 2.3 million Americans. It is characterized by extreme mood swings, including episodes of mania and depression. Acute agitation is common in patients with bipolar disorder, which requires urgent management to relieve distress and to prevent escalation to aggressive behavior.
A clinical trial was conducted to evaluate the effect of sublingual dexmedetomidine, a sedative, on symptoms of acute agitation in patients with bipolar disorder. The trial enrolled 380 adults with bipolar I or II disorder and mild to moderate agitation. Participants were randomized to 3 groups: sublingual dexmedetomidine 180 μg, sublingual dexmedetomidine 120 μg, or placebo. The primary efficacy endpoint was the mean change from baseline at 2 hours for the Positive and Negative Syndrome Scale-Excited Component (PEC) total score.
The trial found that sublingual dexmedetomidine at a dose of 180 μg or 120 μg reduced mild to moderate agitation in patients with bipolar disorder. Two hours after taking the medication, the mean changes from baseline in PEC total score were −10.4 for sublingual dexmedetomidine 180 μg, −9.0 for sublingual dexmedetomidine 120 μg, and −4.9 for placebo. Treatment effects began 20 minutes after taking the medication among patients in the sublingual dexmedetomidine groups.
Adverse events occurred in 35.7% of patients taking 180 μg of dexmedetomidine, 34.9% taking 120 μg, and 17.5% taking placebo. The most common adverse events in the dexmedetomidine groups were somnolence, dry mouth, hypotension, and dizziness.
This clinical trial provides evidence that sublingual dexmedetomidine is effective in treating acute agitation associated with bipolar disorder. However, further research is needed to understand the spectrum of patients for whom this treatment would be effective and feasible and to better understand the clinical importance of the observed effect size.
It is important to note that clinical trials are conducted to evaluate the safety and efficacy of new treatments, and the results of these trials are used to inform clinical practice. If you or a loved one are experiencing symptoms of bipolar disorder, it is important to seek the advice of a healthcare professional. They can provide a proper diagnosis and recommend appropriate treatment options, which may include medication, psychotherapy, and lifestyle changes.
Sublingual dexmedetomidine at a dose of 180 μg or 120 μg has been found to reduce mild to moderate agitation in patients with bipolar disorder. This clinical trial provides evidence for the efficacy of this treatment option, but further research is needed to fully understand its potential benefits and risks. If you or a loved one are experiencing symptoms of bipolar disorder, it is important to seek the advice of a healthcare professional to receive a proper diagnosis and treatment.