Home Medizin Erste Erkenntnisse unterstützen Psilocybin bei bipolarer Depression

Erste Erkenntnisse unterstützen Psilocybin bei bipolarer Depression

von NFI Redaktion

A small, non-randomized clinical trial suggests that a dose of synthetic psilocybin combined with psychotherapy significantly reduces treatment-resistant depression associated with bipolar II disorder (BDII). However, the investigators and other external experts warn against overinterpreting these results.

Three weeks after taking psilocybin and undergoing psychotherapy, the depression scores of all 15 participants decreased by an average of 24 points. Twelve met the criteria for a response, and 11 for remission.

This benefit persisted until the 12-week mark, with 12 participants (80%) meeting the criteria for both response and remission. There were no reports of mixed or manic symptoms, psychotic symptoms, or suicidal thoughts.

Given the small, open design of the study, the results should be interpreted with caution. However, the researchers say that the results are promising.

„The results of this study are encouraging and support the clinical trial of psychedelics in patients with treatment-resistant bipolar II disorder,“ said lead researcher Scott Aaronson, MD, scientific director of the Institute for Advanced Diagnostics and Therapeutics at Sheppard Pratt Health System in Baltimore, Maryland. „One participant compared the transformation she experienced to taking a deep breath after years of breathing through a straw.“

The results were published online in JAMA Psychiatry on December 6, 2023.

Underserved Population
Previous studies show that psilocybin effectively alleviates symptoms of treatment-resistant depression, severe depressive disorder, and anorexia nervosa, mostly with only mild to moderate side effects.

Individuals with bipolar disorder (BPD) have been excluded from psilocybin studies in the past two decades. The researchers attribute this to anecdotal evidence that psychedelics may lead to manic episodes in patients with borderline personality disorder, even though empirical evidence for these effects is limited.

Fifteen participants (9 women; average age 37.8 years) with BDII who had been experiencing an episode for more than three months and had failed at least two medications in the current episode participated in this study.

The participants discontinued all psychotropic medications at least two weeks before the study and received 25 mg of synthetic COMP360 psilocybin in a controlled environment. The psychotherapy included three sessions before dosing, one during the 8-hour dosing day, and three integration sessions after treatment.

Depression was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) at six points during the 12-week study.

In week 3, all 15 participants had lower MADRS scores, with an average decrease of 24 points (P < .001). Twelve participants met the response criteria of a reduction in MADRS scores of ≥ 50%, and 11 met the criteria for remission of a MADRS score of ≤ 10 (both) (P < .001). MADRS scores were significantly lower at all time points after treatment than at the start of the study, and the improvement persisted even after 12 weeks. The participants were also monitored for mania and suicidality at various points during the study, and no significant changes from baseline were noted. "As an initial foray into this underserved and treatment-resistant population, caution should be exercised in overinterpreting the results," the authors note, adding that the results may not apply to patients with BDI or BDII in a mixed or hypomanic phase of their illness. No Final Conclusion In an accompanying editorial, David B. Yaden, PhD, of Johns Hopkins University School of Medicine, Baltimore, Maryland, and colleagues wrote that the results are "alluringly suggestive," but ultimately do not say anything definitive about the efficacy of psilocybin in BDII. "The danger is that some individuals will recognize the large (but uncontrolled) effect size and believe that a new treatment for bipolar II has been discovered that is substantially better than all other treatments while neglecting to mention the absence of a control condition and the significant psychosocial effects included in the study," Yaden and colleagues wrote. They also point out that, due to the limitations of the study, including the small sample size and the absence of a control group, "it is inevitable that the large effect size before and after the study not be overinterpreted." However, Yaden and colleagues also described the safety data as "compelling" and suggested that the safety profile could influence the exclusion criteria in future studies involving individuals with BPD. "The results of the present study provide preliminary evidence that individuals with bipolar II may be safely included in the study samples, without risk of triggering hypomanic episodes," they wrote. "It also suggests a reevaluation of the need to exclude individuals with purely familial bipolar II disorder, as has been the case in several studies." The study was funded by COMPASS Pathways, who provided the study drug. Aaronson disclosed grants and non-financial support (provision of drugs) from COMPASS Pathways during the conduct of the study, as well as personal fees from LivaNova, Neuronetics, Genomind, and Sage Therapeutics outside the submitted work. Additional disclosures are noted in the original article.

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