MindBio Therapeutics has administered the first doses of MB22001 to patients with major depressive disorder in its Phase IIa clinical trial.
This landmark microdosing study is claimed to be the only clinical trial in the world to be approved for take-home use of lysergic acid diethylamide (LSD).
The microdose of this psychedelic medicine is sub-hallucinogenic.
The open-label study intends to assess the tolerability, feasibility and effectiveness of a proprietary titratable form of LSD MB22001 in 20 participants. They will receive the dosage every third day for eight weeks.
MindBio Therapeutics CEO Justin Hanka said: “We are delighted to begin this important clinical trial in patients suffering from the debilitating effects of depression and we hope that this medicine and unique treatment protocol will be effective at mitigating those symptoms and provide a superior treatment outcome to the current available treatment options for depression.”
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The study data from the trial is used to commence a larger Phase IIb randomised, triple-dummy-controlled trial in depressed patients.
The sleep recording data from the earlier Phase I trial in 80 healthy individuals carried out over 3,200 days showed an average of 24 minutes of additional total sleep time and eight minutes of additional rapid eye movement sleep.
Subjects also showed reduced feelings of anger and irritability, along with improvements in subjective feelings of energy, creativity, happiness, wellness and social connectivity on the days the dose was taken.
With a package of proprietary solutions, the company is planning to market the microdosing treatments to ensure safe and effective usage of psychedelics at home.
MindBio said the take-home approvals are necessary for testing the ecological validity, as it is progressing with its commercialisation strategy for global regulatory approvals.