MindBio Therapeutics Corp. announced the successful ethics approval received for a Phase 2 randomized double-blind and placebo controlled clinical trial in advanced stage cancer patients using microdoses of Lysergic Acid Diethylamide (LSD) and Meaning Centred Psychotherapy in a world's first LSD take-home 6-week trial involving a total of 40 participants. Patients with a stage IV solid tumour cancer and experiencing emotional distress will be
randomized into the trial. Meaning Centred Psychotherapy is a well-established psychotherapeutic intervention in advanced cancer patients with symptoms of anxiety and or depression. Patients with cancer often develop ongoing, clinically significant, symptoms of psychological distress. People with advanced-stage cancer have a high prevalence of depression, anxiety and reduced quality of life with 40% meeting the criteria for a mood disorder. MindBio is focused on developing targeted treatments to meet this need in cancer patients. Such disorders can significantly impact a patient's end of life experience and can contribute to feelings of loss of meaning, hope, or a desire for hastened death (otherwise known as `existential distress'); which is regarded as one of the most challenging problems in palliative medicine. Additionally, depression and anxiety have been associated with decreased treatment adherence, prolonged hospitalisation, decreased quality of life and increased suicidality in this population. Depression is itself an independent risk factor of early death in cancer patients. The efficacy of standard treatment approaches to anxiety and depression in cancer patients is mixed. The onset of clinical improvement with anti-depressants in cancer is delayed, relapse rates are high, and significant side effects compromise treatment adherence. LSD-Microdosing data from a Phase 1 clinical trial in healthy individuals showed increases in energy, social connectivity, creativity, wellness and happiness and microdoses of LSD are well tolerated.