Clinical Trial To Assess LSD Microdosing For PMS

MindBio Therapeutics Corp. Said “MB22001, a unique self-titratable lysergic acid diethylamide (LSD) designed for safe take-home microdosing,” has been approved for take-home use in a pair of clinical trials.

“This women’s health study shows that women can effectively treat premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) without the side effects associated with the combination of antidepressants and oral contraceptives commonly used to treat them. ”, the company said in a press release.

The company “currently has multiple Phase 2B clinical trials underway in its portfolio, including a series of world-first clinical trials,” a press release said.

“This month, MindBio aims to present secondary data from our recently completed Phase 2A study of MB22001 in patients with major depressive disorder. “We have already met our primary endpoints using the MADRS, which demonstrated a 60% reduction in depressive symptoms and 53% complete remission of depression by week 8 of treatment.” said. release.

“In the secondary data presentation, we will report on post-treatment effects using the MADRS and several other key clinical scales to measure the effects of MB22001 on the mental health of each clinical trial participant. This data is critical to fully understanding the impact this new drug has on patients and, if results remain positive, strengthens the drug’s position moving toward Phase 3 clinical trials. Become.”

As Benzinga explains, MindBio’s theory is that it “can be used acutely during specific periods of the menstrual cycle in targeted doses to treat symptoms of negative mood.”

“This paper is based on three key facts: a) MB22001’s mood-elevating effects on the day of acute administration were demonstrated in MindBio’s Phase 1 trial; b) MindBio’s mood-elevating effects in patients with depression A Phase 2a open-label study showed long-term mood improvements, and c)) there are reports in the gray literature of people self-treating PMS/PMDD using microdosing of LSD.” and Benzinga Said. “Premenstrual syndrome (PMS) is estimated to affect approximately 25% of all menstruating women, which equates to 956 million women worldwide. A severe form is called premenstrual dysphoric disorder (PMDD), which affects 3 to 8 percent of menstruating women. Current treatments for these problems occur during the luteal phase of the menstrual cycle. Selective serotonin reuptake inhibitors (SSRIs) are administered continuously or daily. Although SSRIs are effective for some patients with PMDD, approximately 40% of women with PMDD do not respond to SSRIs and develop PMDD. Common side effects of using SSRIs include nausea, decreased energy, somnolence, fatigue, decreased sex drive, and sweating.

mind bio the bill itself “Pioneering clinical research into micro-dosing of psychedelic drugs to treat a variety of medical conditions including depression, anxiety, PTSD, panic disorder, chronic pain, and opiate addiction” to “discover potential new treatment options.” Investing in “clinical research”. And we aim to generate new medicines and treatment plans from groundbreaking microdosing research. ”

The company is providing detailed background on this year’s clinical trials for MB22001.

“A Phase 2a clinical trial with MB22001 for major depressive disorder was completed in March 2024. In the Phase 2a clinical trial, 53% of depressed patients enrolled in the trial Overall, the MADRS score (Montgomery-Asberg Depression Rating Scale) decreased by 14.1 points after treatment, the global standard for measuring the severity of clinical depression. “Overall, we demonstrated an impressive 60% reduction in depression symptoms at week 8 of the study,” the company explained, adding, “We have just begun dosing in a Phase 2b depression trial,” he added.

“In this randomized, active, placebo-controlled trial, 90 patients with major depressive disorder will be given trace doses of MB22001 or an active placebo over eight weeks. At the end of the eight weeks, the placebo group will be given MB22001 to test. To ensure they get the chance, all participants in the placebo and drug groups will be offered an eight-week extension.” “A second Phase 2B trial in terminally ill cancer patients is also currently underway. We evaluate the feasibility of conducting a randomized controlled trial comparing meaning-centered psychotherapy with standard meaning-centered psychotherapy.”

Participants in the trial will be “randomly assigned to receive psychotherapy alongside the administration of either microdoses of LSD or a placebo,” MindBio said.

“The feasibility, acceptability, safety, and potential psychological benefits of this intervention will be evaluated. Our findings will inform the development of larger trials and support the use of psychedelics in advanced cancer.” “This provides the first indication of the potential benefits of microdosing.”