Developing a new treatment for patients suffering from Major Depressive Disorder

CLE-100 is a tablet being developed as an add-on treatment for patients who do not get enough relief from standard antidepressant therapy. It targets a more rapid antidepressant effect than most current medications.

CLE-100 is a new investigational drug that has not been approved for commercial distribution.

Major depression can be devastating for patients and their loved ones.  Episodes of major depression are characterized by depressed mood or loss of interest or pleasure in usual activities that lasts for at least 2 weeks and often much longer. These episodes are accompanied by an array of symptoms including changes in eating or sleeping patterns, fatigue, difficulty concentrating, indecision, thoughts of death or suicide, or feelings of despair. About 20% of the population will experience major depression at some time during their lifetime and major depressive disorder (MDD) is a major public health problem.

While many treatments are available, they are often not effective enough.  The National Institute of Mental Health-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D), the most comprehensive and largest clinical study of MDD, showed that remission of depressive symptoms is achieved in only one-third of patients after their first antidepressant treatment trial with an established antidepressant medication and 33% of patients did not reach remission even after treatment with 4 different medications (Rush et al. 2006). Since most antidepressant medications generally take 4- 6 weeks to relieve depression, patients who required multiple medication trials spent months waiting for relief to come.