Clinically Meaningful Improvements
Science, helping people get their lives back
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Our trials are designed to evaluate the safety of low doses of psilocybin, utilizing a novel dosing paradigm to optimize pharmacology while maximizing access and reducing the burden for patients and providers.
Programs
Medical Indications
Premenstrual Dysphoric Disorder (PMDD) - MLS101
Obsessive Compulsive Disorder
(OCD) - MLS301
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Clinical Trials
PMDD is characterized by a variety of symptoms that could include marked mood lability, irritability, anger, depressive thoughts with feelings of hopelessness and low self-esteem, anxiety and or feeling tense/on edge, low interest, poor concentration, and changes in sleep and appetite. These symptoms cause significant distress or interference in work or functioning and quality of life. PMDD is associated with a high risk of suicide. Typically, PMDD is seen in women in the final week before the onset of menses and symptoms typically improve within a few days after the onset of menses to become minimal or absent. The lifetime prevalence of this disorder is approximately 6%. Current treatment options (SSRIs, hormonal treatments) offer partial response and raise tolerability concerns underscoring the need to find safe and efficacious treatment alternatives. There is a high co-morbidity of PMDD with Major depression and other forms of depressive disorders.
OCD is characterized by the presence of repeated and intrusive unwanted thoughts or images that cause distress and anxiety (Obsessions) and an attempt to ignore or suppress these thoughts or images by some other thought or action (Compulsions). For example, excessive and repeated hand washing, ordering, checking, or mental acts like counting, repeating words silently, etc. OCD behaviors are highly disruptive and time-consuming and cause marked impairment in social, occupational, or other areas of functioning. The prevalence of OCD is approximately 1.2% with a slightly higher rate in adult women. The onset of OCD is typically seen during adolescence to young adulthood, and if left untreated has a chronic course and low remission rate of approximately 20%. The risk for suicide or suicide attempts is much higher than in the general population (5.5 odds ratio) with a mean rate of suicide attempts of 14.6% and suicidal ideation of 44.1%. Current treatment options include SSRIs, antipsychotics, and behavior therapies that offer limited benefits.
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