This study is looking at Major Depressive Disorder, which is a condition where people experience persistent feelings of sadness and loss of interest in activities that can affect daily life. Some people with this condition may also experience anxious distress, which means having feelings of worry or tension along with their depression. The study will test a medication called SPT-300, which contains brexanolone caprilcerbate, and compare it to placebo. The medication comes in capsule form and is taken by mouth.
The purpose of this study is to see how well SPT-300 works as a single treatment for reducing symptoms of depression in adults who have Major Depressive Disorder, whether or not they also have anxious distress. The study will also look at how safe the medication is and how well people tolerate it. Researchers want to understand if this treatment can help improve the symptoms that people with depression experience.
During the study, participants will be randomly assigned to receive either SPT-300 or placebo. The study is double-blind, which means neither the participants nor the doctors will know who is receiving which treatment. Participants will take the medication for a period of time, with the maximum daily amount being 375 milligrams. The treatment period can last up to six months. Throughout the study, participants will have regular visits where doctors will assess their depression symptoms and overall condition to see if there are any changes. The study will measure depression symptoms using standard rating scales to determine if the treatment is working.
Bulgaria 
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Germany 
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Slovakia 
