Tapering off Antidepressant Before Psychedelic Therapy and Validity Concerns in MDMA Trials: Insights from Psychedelic Mindset Institute

Tapering off Antidepressant Before Psychedelic Therapy and Validity Concerns in MDMA Trials: Insights from Psychedelic Mindset Institute

Jen Snyder

Welcome to Psychedelic Mindset Institute, where we dive into the natural cures for anxiety with the fascinating realm where mental health treatment intersects with psychedelic therapy. Today, we unravel the impact of antidepressant use on psychedelic therapy outcomes and scrutinize concerns surrounding the validity of clinical trials involving MDMA.

Navigating Antidepressant Use Before Psychedelic Therapy:

Delving into the realm of psychedelic therapy, particularly with substances like psilocybin, we encounter an intriguing correlation with antidepressant medications. Notably, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), commonly used antidepressants, interact with the serotonin system in ways akin to classic psychedelics.

In the context of clinical trials, participants are often required to discontinue these medications before embarking on psychedelic treatment. However, the ramifications of tapering off SSRIs and SNRIs on individuals' responses to psychedelic-assisted therapy remain shrouded in uncertainty.

A recent study, spotlighted in the British Association for Psychopharmacology, undertook a reanalysis of data from a clinical trial comparing psilocybin-assisted therapy with the SSRI escitalopram in addressing moderate to severe major depressive disorder. Intriguingly, findings unveiled that participants who were not using an SSRI or SNRI prior to the study experienced more substantial improvements in depression scores over six weeks post-psilocybin therapy compared to those who underwent antidepressant tapering.

While these revelations hint at a potential correlation between SSRI or SNRI usage and responses to psilocybin therapy, researchers are also attentive to the possibility that discontinuing antidepressants could exacerbate depressive symptoms, thereby influencing outcomes. Despite lesser improvements among discontinuers versus unmedicated participants, those administered escitalopram showcased superior outcomes compared to the psilocybin group. Co-lead author Tommaso Barba underscores the imperative for further exploration into the intricate dynamics of antidepressant discontinuation effects in psychedelic research.

Upholding Rigor in MDMA Clinical Trials:

Recent scrutiny from the Institute for Clinical and Economic Review (ICER) cast a discerning eye on clinical trials conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS) employing MDMA-assisted therapy for PTSD treatment. Renowned for evaluating medical treatments' cost-effectiveness, ICER voiced significant reservations regarding the validity of findings emanating from MAPS's trials.

ICER's concerns encompass methodological and ethical quandaries, including instances of functional unblinding, wherein participants and researchers potentially discerned whether they received MDMA or a placebo. Furthermore, ICER flagged scenarios where trial participants reported adverse outcomes and were reassured by researchers, sparking ethical dilemmas. Notably, one participant's experience of sexual abuse underscored broader ethical concerns.

In its evaluation, ICER adjudged the evidence for the efficacy of MDMA-assisted psychotherapy for PTSD as "insufficient," citing apprehensions about the validity of MAPS's clinical trials. Despite outreach efforts to MAPS's for-profit arm, Lykos Therapeutics, ICER received no response. The public commentary period on the draft report extends until April 22.

As we navigate the promising terrain of psychedelic therapy, it becomes imperative to confront potential confounders such as antidepressant use and uphold the integrity of clinical trials. By doing so, we pave the way for the delivery of safe and efficacious treatments to those grappling with mental health challenges. At Psychedelic Mindset Institute, we remain committed to unraveling the complexities of psychedelic therapy and advancing the frontiers of mental health care.

 

If you are interested in becoming a licensed psilocybin facilitator check out Psychedelic Mindset Institute's Programs Flat Rate Tuition https://psychedelicmindsetinstitute.com/

Back to blog

Leave a comment