Alternative Treatment For Bipolar II Depression: Psilocybin Safe And Effective, AMA Study Finds

A COMPASS Pathways CMPS-backed clinical trial assessing psilocybin-assisted psychotherapy for bipolar II disorder has provided preliminary data on the treatment’s safety and efficacy, reported Marijuana Moment’s Ben Adlin.

Published by the Journal of the American Medical Association (JAMA Psychiatry,) the small pilot study’s findings suggest Safe of one 25mg dose of the biotech’s synthetic psilocybin COMP360 paired with psychotherapy for treating the mentioned mental health condition, a “treatment-resistant cyclical mood disorder” commonly associated with debilitating and difficult-to-treat depressive episodes.

See Also: COMPASS Pathways: New Data & Insight On Psilocybin Therapy For Treatment-Resistant Depression

The study, conducted at Baltimore’s Sheppard Pratt Hospital, was non-randomized and placebo-controlled and involved 15 participants with “well-documented” treatment-resistant BDII depression of marked severity and a lengthy duration of the current depressive episode. 

Its design involved seven psychotherapy sessions: three pre-treatment (aka preparation,) one during psilocybin dosing (eight hours) and three post-treatment (aka integration.)

Study PI, Dr. Scott Aaronson said the results are encouraging and further support the clinical study of psychedelics in patients with treatment-resistant bipolar II. 

"One participant compared the transformation she experienced to taking a deep breath after breathing through a straw for years. These are the types of stories we are hearing from people who struggled with this disorder for years, many who had lost hope that their bipolar II could ever be treated," Aaronson shared. 

Sheppard Pratt's Center of Excellence for Psilocybin Research and Treatment is conducting clinical trials on psilocybin-assisted psychotherapy for anorexia, treatment-resistant depression and chronic suicidal ideation.

Early Results

Preliminary outcomes showed:

• Most participants remitted rapidly (ie, within 1 week of dosing,) and in 12 of total 15 participants response and remission criteria on symptoms persisted 12 weeks post-treatment. 

• Participants’ self-reported quality of life scores showed “similar improvements.” 

• The 3 participants that restarted medication due to lack of benefit or relapse following improvement “generally had poorer response throughout the trial,” authors stated.

• In terms of safety, metrics of suicidal ideation and mania “did not change significantly” post-treatment as compared to baseline, with “no signal of worsening mood instability or increased suicidality.”

All participants were fully withdrawn from antidepressant and mood-stabilizing medications “at least two weeks prior to dosing.” Nine did not retake medications during the 12-week duration of the study, while six restarted at least one medication.

Others had mixed results, including one who “remitted at week 3, relapsed at week 6, dropped out of the study, and restarted medication and was coded as a nonresponder for weeks 9 and 12” and another participant who restarted medication “at week 2, before the primary outcome visit at week 3, and was considered a nonresponder throughout the study.”

The trial excluded patients with conditions including a history of bipolar I, schizophrenia, psychosis, delusions, borderline personality disorder, or any substance use disorder within the past year.

Researchers concluded that the trial’s findings “suggest efficacy and safety of psilocybin with psychotherapy in BDII depression.” 

They warned that these results cannot be extrapolated to other conditions like bipolar I disorder or bipolar II “in a mixed or hypomanic phase of their illness,” and stated that further follow-up is needed to better understand the treatment’s longer-term potential impacts.

Within the psychedelic community, renowned researchers David B. Yaden, Natalie Gukasyan and Sandeep Nayak from Johns Hopkins Centre for Psychedelic and Consciousness Research (CPCR) have jointly written an editorial at the same journal providing a scientific take on the implications of the new findings.

Photo: Benzinga edit with photo by Krakenimages.com and Cannabis_Pic on Shutterstock.