The FDA has issued new guidance regarding the use of computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders during the coronavirus disease 2019 (COVID-19) pandemic.
The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).
Results showed a mean change from baseline of -9.28 points (95% CI, -10.23 to -8.32) on the HAM-A total score in patients treated with troriluzole compared with -9.35 points (95% CI, -10.34 to -8.36) with placebo (P =.917).
The update was prompted by an FDA review of 10 cases of constipation in clozapine-treated patients that resulted in serious complications.
While claims about the benefits of Vivitrol were clearly presented in the ad, serious risks, such as vulnerability to opioid overdose, were not communicated.
The FDA has granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorder.
Currently, there is no FDA-approved therapy to treat the negative symptoms of schizophrenia.
The application includes data from the ENLIGHTEN-1 and ENLIGHTEN-2 studies, in which treatment with the combination therapy was compared with placebo or olanzapine monotherapy in patients with schizophrenia.
Among patients who received stellate ganglion block (n=74), the adjusted mean CAP-5 total symptom severity score change from baseline was -12.6 points (95% CI, -15.5, -9.7 points) vs -6.1 points (95% CI, -9.8, -2.3 points) for those who received sham treatment.
A recent report published in the journal Neuropsychobiology describes the case of a 34-year-old woman with major depressive disorder whose symptoms improved following the initiation of an elimination diet.
