Patients who are eligible for the study and provide written informed consent will randomized to one of two groups, 90 mg dose of Dextromethorphan (twice a day) or the placebo on a 1:1:1 basis. The trial will utilize Clinstat, a free, statistical software, to perform randomization of patients. The random number generation will assign all the participants to the treatment or placebo group by generating a number that corresponds with Dextromethorphan or the placebo. An outside committee that has no interest in the study and is not connected to anyone conducting the study will be responsible for the allocation of participants. This will limit the risk of introducing bias into analyses and results.
This is a…show more content… Therefore, the rationale for the dosage of Dextromethorphan for this study is based on previous trials that have determined the maximum tolerated dose of Dextromethorphan based on the dose-limiting toxicity. Steinberg et al. orally administered dextromethorphan in an escalating mechanism, every 6 hours for 5 dose (90 mg, 120, 150, 180, and 210 mg. At 210 mg, the main side effects observed included sensation of a ‘‘high’’ or drunken feeling, nystagmus, nausea or vomiting, and dizziness. Others included blurred or distorted vision, hallucinations, dysphoria, and slurred speech. The trial showed that at 90mg dextromethorphan was sufficient to engage all of the antidepressant-related receptor effects . In another study where dextromethorphan was used to investigate its analgesic properties in subjects with Fibromyalgia, dextromethorphan was effective at a dose of 90mg but not 60mg. The pathway mediating the effect was believed to be the N-methyl-D-aspartate (NMDA) receptors. Adequate binding at the NMDA receptor is important in this study because NMDA-receptor antagonism is one of the mechanism considered to impact Dextromethorphan potential as a rapid acting antidepressant. Therefore, it is assumed that a dose of at least 90mg is needed to achieve measurable NMDA-receptor activity, and thus an antidepressant response .
5.G. Patient Follow‐Up
After randomization to the treatment or placebo group, patient will be seen on the 3rd day were