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Brain imaging study reveals how psilocybin eases depression

Magic mushroom compound increases brain connectivity in people with depression

“For the first time we find that psilocybin works differently from conventional antidepressants — making the brain more flexible and fluid, and less entrenched in the negative thinking patterns associated with depression,” says Imperial College London researcher David Nutt.

A new brain imaging study found that psilocybin increases brain network integration, whereas a common antidepressant, escitalopram, had no impact on brain network organization. 

fMRI scans showed that psilocybin reduces activity in the default mode network (DMN), a region associated with introspection that’s often overactive in patients with depression, causing negative fixations about one’s self and the future. 

The DMN became more connected with other regions like the salience network and the executive network, which are often impaired in patients with depression (as well as autism and OCD).

Essentially, this helps “open up” the brain, breaking rigid and restrictive patterns.

These findings may explain why psilocybin outperformed escitalopram in treating depression.

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Ketamine found to be safe and effective for teen depression

Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial

One in four young adults contemplated suicide last year.

Clearly, something needs to change. Could ketamine be the solution?

A study last month found that ketamine was well-tolerated in adolescents aged 13-17 and significantly reduced their depression symptoms.

76% of participants had at least a 50% reduction in depression scores within 3 days of receiving a ketamine infusion, compared to 35% of the placebo group.

The teens had tried between 1 and 7 antidepressants without success prior to the treatment. They all remained on their medications during the trial (SSRIs, non-SSRI antidepressants, mood stabilizers, or lithium) with no serious adverse side effects.

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If you’re on antidepressants, psilocybin may be safer than MDMA

Psilocybin safer to take with psychiatric medications than MDMA, researchers say

An analysis of 40 publications found that MDMA interacts with antidepressants more than psilocybin.

Taking MDMA on antidepressants could lead to toxic levels of serotonin and may be fatal, with MAOIs posing a particularly high risk.

While there is less research on psilocybin, a study from MindMed and Liechti Labs found that the SSRI escitalopram was safe to take with psilocybin, and even reduced trip anxiety.

However, the analysis found that buspirone, chlorpromazine, ketanserin, or risperidone reduced psilocybin’s subjective effects.

This helpful chart has more information on how psychedelics interact with antidepressants, but remember that this is not medical advice. 

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Two approaches to treating depression with DMT

Small Pharma Expands Potential of Commercial Portfolio with DMT-based Psychedelic Assets

After finding its DMT formulation to be well-tolerated, Small Pharma (DMT) is launching two new trials this year. 

One will assess how DMT interacts with SSRIs in patients with depression and the other will compare the drug’s effects when administered through muscles versus veins. 

The company has also developed a form of DMT that lasts longer than the typical 30 minute trip, but is still much shorter than a psilocybin or LSD trip.

Biomind Labs (BMND) is taking the opposite approach. The company reduced a DMT trip to just 10-15 minutes by making a formulation that’s inhalable.

Biomind’s formulation will be assessed in a Phase II trial for treatment-resistant depression, which just received approval by the Brazilian Institutional Review Board.

We’re eager to see if the length of the trip makes a difference!

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Biomind Labs Inc.

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Filament Health and Cybin Therapeutics Announce Approval for Phase II Clinical Trial for Depression

Filament Health and Cybin Therapeutics Announce Approval for Phase II Clinical Trial for Depression

Trial to investigate the effects of Filament’s botanical psilocybin drug candidate and Cybin Therapeutics’ protocols in treating major depressive disorder in patients taking SSRIs.
Patient enrollment is expected to commence in Q3’22

Vancouver, British Columbia, January 31, 2022  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced Health Canada approval for a phase 2 clinical trial using PEX010, the Company’s botanical psilocybin drug candidate. Cybin Therapeutics (“CT”), a private therapeutic bioscience company on a mission to discover and develop psilocybin assisted therapeutic protocols, has licensed PEX010 (25 mg) from Filament for use in the trial. The trial is expected to begin in Q3’22 and will include individuals with major depressive disorder who are undergoing selective serotonin reuptake inhibitor (SSRI) therapy, commonly used to treat depression, as well as those who are SSRI-naive.

“Health Canada’s approval is a testament to both the validity of this trial as well as Filament’s ability to produce and license pharmaceutical-grade botanical drug candidates,” said Filament Chief Executive Officer, Benjamin Lightburn. “The effect of psilocybin therapy in patients taking traditional SSRI antidepressant medication is an extremely important investigation and we are thrilled to participate in this important research.”

“Many Canadians who battle depression undergo SSRI therapy, and until now, this has generally meant exclusion from psychedelic assisted psychotherapy (PAP) clinical trials,” said Josh Taylor, Founder of Cybin Therapeutics. “If it can be demonstrated that PAP can be safely and effectively given to patients on SSRIs, many will stand to benefit. We feel this is an outstanding opportunity to show Health Canada that Cybin Therapeutics can improve patient outcomes with our team and developed protocols.”

Filament has also licensed PEX010 (25 mg) to CT for additional phase 2 clinical trials, which are expected to begin in the fourth quarter of 2022. Both trials will be led by Dr. Reg Peters and Dave Phillips.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary technology platform enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.

MEDIA CONTACT

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

Cybin Therapeutics
604.318.0458
info@cybintherapeutics.com

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning Filament’s upcoming clinical trials; strategic and growth plans of the Company including intellectual property; and the impact, timing and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

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MDMA works better than antidepressants

Latest Trials Confirm the Benefits of MDMA – the Drug in Ecstasy – for Treating PTSD

Plus, the effects are long-lasting!

A recent analysis found that, on average, patients who received MDMA-assisted therapy experienced a 22 point reduction in PTSD scores, whereas daily antidepressants only reduced scores by 6 to 14 points. 

One year after receiving the treatments, patients still reported benefits:

  • 84% reported improved feelings of well-being
  • 71% had fewer nightmares
  • 69% had less anxiety
  • 66% had improved sleep

Why is it so effective? MDMA reduces feelings of intense anxiety, allowing patients to open up and work through traumatic memories without fear.

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The findings from COMPASS’s depression study keep coming!

COMPASS Pathways announces positive outcome of 25mg COMP360 psilocybin therapy as adjunct to SSRI antidepressants in open-label treatment-resistant depression study

COMPASS Pathways’ (CMPS) announced that patients taking SSRI antidepressants in conjunction with psilocybin therapy had similar outcomes and fewer side effects compared to those who withdrew from SSRIs before the study.

Five patients who withdrew from SSRIs had serious adverse effects, such as suicidal ideation, when given the largest dose. None of the patients on SSRIs had this experience. 

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Antidepressants + psilocybin

MindMed and Liechti Lab publish first human data on the interacting effects of an SSRI and psilocybin

Do patients need to come off of antidepressants before trying psilocybin therapy?

New research from MindMed (MNMD) and Liechti Labs suggests that it’s not necessary – and there are actually benefits of combining the two.

Escitalopram (aka Lexapro) did not affect the way psilocybin was processed and helped reduce negative side effects like anxiety and high blood pressure.

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MindMed and Liechti Lab publish first human data on the interacting effects of an SSRI and psilocybin

MindMed and Liechti Lab publish first human data on the interacting effects of an SSRI and psilocybin

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD, NEO: MMED, DE: MMQ; the “Company”), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce the publication of the first data on the interaction of the selective serotonin uptake inhibitor (SSRI) escitalopram with the acute response to psilocybin in humans. The publication resulted from a randomized, double-blind, placebo-controlled, crossover pharmacology study in healthy volunteers conducted by the University Hospital Basel Liechti Lab and sponsored by MindMed.

The study found that escitalopram pre-treatment had no relevant impact on positive mood effects of psilocybin but significantly reduced negative effects like anxiety and adverse cardiovascular reactions, compared with placebo pre-treatment in the study’s healthy volunteers. Escitalopram did not alter the pharmacokinetics of psilocin. Escitalopram did not alter QTc intervals or circulating BDNF levels before or after psilocybin administration. The study was published in Clinical Pharmacology and Therapeutics. The full-text can be accessed here: https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2487

“Two key questions arise around the use of psilocybin in patients undergoing antidepressant treatment,” said Prof. Matthias Liechti, the principal investigator of the study. “First, for safety reasons, should a patient stop using antidepressants before receiving psilocybin? Second, if there is no safety risk, will the antidepressant reduce the patient’s response to psilocybin? These results indicate that psilocybin may be dosed during escitalopram treatment without apparent impact on the effect of psilocybin. Thus, the study answers the first question and provides a positive indication for the second.”

The study results highlight important areas for future research. Dr. Miri Halperin Wernli, Executive President of MindMed, added: “If the results are confirmed in subsequent studies, with other substances and in patients rather than healthy individuals, antidepressants may no longer need to be stopped for psilocybin treatment. Further studies are needed with a longer antidepressant pre-treatment time and patients with psychiatric disorders to further define interactions between antidepressants and psilocybin or other psychedelics.”

 

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the safety, effects and benefits of escitalopram pre-treatment and the acute response to psilocybin in humans, the results for future studies and the need for antidepressants to be stopped for psilocybin treatment. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are  available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

 

Media Contact: mindmed@150bond.com

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Psilocybin or SSRIs? Why not both!

MindMed and Liechti Lab Provide Results from their Psilocybin R&D Collaboration

A new study found that combining SSRIs and psilocybin is not only safe, but may be beneficial!

Yesterday, MindMed (MNMD) announced the findings from several ongoing studies conducted in collaboration with UHB Liechti Lab.

In one study, psilocybin was found to be safe to administer with an SSRI antidepressant and did not reduce the psychedelic experience. Two weeks prior to the psilocybin dose, volunteers were give a daily pretreatment of the SSRI escitalopram. As a result, the volunteers experienced reduced anxiety and blood pressure increases that occur with psilocybin administration.

Another study compared the perceptual effects of psilocybin to LSD and revealed that a 20 mg dose of psilocybin is equivalent to 100 mcg of LSD.

The company will continue to analyze the study data and will publish additional findings later this year.

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