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LSD trial for the treatment of adult ADHD initiated

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LSD trial for the treatment of adult ADHD initiated

MindMed is expected to begin enrolling patients immediately into its proof-of-concept exploratory trial for the use of LSD to treat adult ADHD.

The trial MindMed is designed to evaluate the therapeutic utility of repeated low doses of LSD in adult ADHD. It is being conducted in collaboration with the University Hospital Basel in Switzerland and Maastricht University in the Netherlands.

CEO, Robert Barrow, commenteD: “We are pleased to activate our first site and excited to initiate patient enrolment of our ADHD proof-of-concept trial.

“The study builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes. Further, low doses of LSD have been shown to be safe, well tolerated and have minimal effects on physiological parameters. 

“In collaboration with our renowned clinical researchers and team of leading investigators, we look forward to driving this exploratory trial forward as part of our broader comprehensive LSD clinical development strategy.”

Dr Matthias Liechti, University Hospital Basel and co-primary investigator of the trial, added: “Psychedelics including LSD have shown beneficial and lasting effects on mood when given at single doses producing psychedelic effects. 

“There is anecdotal evidence for possible benefits of low to very low doses of psychedelics given repeatedly. This is the first controlled study to validly evaluate therapeutic effects of very low doses of a psychedelic in patients.”

“We are very much looking forward to initiating our ADHD trial with repeated low doses of LSD, which will be conducted at two top European clinical therapeutic sites,” added Dr Miri Halperin Wernli, executive president of MindMed. 

“We have designed a robust, randomised clinical trial to replicate and extend the promising findings of previously conducted smaller, open-label trials. This trial will evaluate our therapeutic regimen in a rigorously controlled setting and will help optimise the dosing schedule, compound selection and clinical management. 

“Further, this trial will provide additional insight into the mechanisms by which psychedelics exert their therapeutic effects.”

See also  Data shows combination psilocybin therapy effective for TBI and PTSD

Research

Psilocybin for major depression trial launches at neuroscience institute

The trial will investigate the compound’s efficacy for major depressive disorder.

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Psilocybin for major depression trial launches at neuroscience institute

Pacific Neuroscience Institute (PNI) has initiated its psilocybin clinical trial that will investigate whether the compound can be an effective treatment for major depressive disorder (MDD).

Located at Providence Saint John’s Health Center, PNI will investigate the safety and efficacy of psilocybin for MDD, evaluating the potential antidepressant effects of a one-time dose.

PNI has begun participant enrolment for the trial. The Treatment & Research In Psychedelics (TRIP) program at Pacific Neuroscience is exploring how altered states of consciousness elicited by psychedelics can be harnessed to change behaviour and improve brain health.

TRIP programme director and addiction medicine specialist, Keith Heinzerling, MD, is the principal site investigator of the study.

Read more: Global coalition launches to push for psilocybin rescheduling

Heinzerling commented: “We are incredibly excited to be able to offer participation in this leading-edge clinical trial to people suffering with depression in Los Angeles and throughout Southern California.”

The PSIL201 Phase II, randomised, double-blinded, placebo-controlled, multi-site trial is sponsored by Usona Institute and began in 2019. Usona Institute will be providing the psilocybin for the trial as capsules.

A total of 100 participants with MDD who have no other medical conditions will be randomised to receive either a single dose of psilocybin or an active placebo.

The primary outcome measure will be change in a standardised depression rating scale (MADRS) 43 days after receiving psilocybin or placebo.

Daniel Kelly, MD, PNI director and founder, and site co-investigator of the study added: ”Given the huge demand for more effective and durable depression therapies, we are thrilled to be joining Usona Institute for this ongoing trial and are hopeful the final results will justify a larger Phase 3 Efficacy trial.”

See also  Study demonstrates psilocybin feasibility for depression in cancer patients
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Review of evidence confirms ketamine reduces suicidal thoughts

A systematic review of all evidence relating to ketamine therapy has been carried out.

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Review of evidence confirms ketamine reduces suicidal thoughts

A review has shown that ketamine therapy is able to rapidly reduce symptoms of depression and suicidal thoughts in the short-term.

Led by the University of Exeter and funded by the Medical Research Council, the systematic review analysed evidence from 83 published research papers on ketamine therapy. 

It showed that the strongest evidence emerged around the use of ketamine to treat both major depression and bipolar depression, with symptoms reducing as quickly as one to four hours after a single treatment, and lasting up to two weeks. 

Single or multiple doses of ketamine resulted in moderate to large reductions in suicidal thoughts. This improvement was seen as early as four hours following ketamine treatment and lasted on average three days, and up to a week.

See also  Groundbreaking ketamine study receives approval for expansion

Additionally, some evidence suggested that repeated treatment may prolong the effects, however, the researchers involved say more high-quality research is needed to determine by how long. 

The review, which included 33 systematic reviews, 29 randomised control trials and 21 observational studies, has been published in the British Journal of Psychiatry Open.

Lead author Merve Mollaahmetoglu, of the University of Exeter, said: “Our research is the most comprehensive review of the growing body of evidence on the therapeutic effects of ketamine to date. 

“Our findings suggest that ketamine may be useful in providing rapid relief from depression and suicidal thoughts, creating a window of opportunity for further therapeutic interventions to be effective.

“It’s important to note that this review examined ketamine administration in carefully controlled clinical settings where any risks of ketamine can be safely managed.”

See also  New findings on how ketamine prevents depression raise treatment hope

For other psychiatric disorders, including anxiety disorders, post-traumatic stress disorders (PTSD) and obsessive-compulsive disorders, the review noted that there is early evidence to suggest the potential benefit of ketamine treatment, and that for individuals with substance use disorders, ketamine treatment led to short-term reductions in craving, consumption and withdrawal symptoms.

Senior author professor Celia Morgan, of the University of Exeter, said: “We’re finding that ketamine may have promising benefits for conditions that are notoriously hard to treat in clinic. 

“We now need bigger and better-designed trials to test these benefits. 

“For example, due to ketamine’s unique subjective effects participants may be able to tell whether they have been given ketamine or a saline solution as the placebo, potentially creating an expectation about the effects of the drug. 

“This effect may be better controlled by having active placebo-controlled trials, where the control group receives another drug with psychoactive properties.”

Ketamine’s therapeutic effects for psychiatric conditions other than depression and suicidal thoughts are based on small number of studies that did not randomise people into different treatment arms. The authors highlight that these effects require replication in larger randomised placebo-controlled trials, which are considered as gold standard.

A number of questions remain unanswered so far, including the optimal dose, route of administration and number of doses of ketamine treatment. 

The authors highlight that there is also a need for further research on the added and interactive benefit of psychotherapy alongside ketamine treatment.

See also  Five-year study shows single ketamine dose reduces suicidal thoughts

Additionally, the importance of ketamine’s acute subjective effects in its therapeutic benefits has not been fully explored, and more research is also needed on how to optimise participants’ preparation for ketamine treatment and the setting in which ketamine treatment is delivered.

The research involved collaboration with the University of British Columbia, and received support from the Society for the Study of Addiction.

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Groundbreaking ketamine study receives approval for expansion

A study exploring the use of ketamine to treat gambling addiction will be expanded to include three additional addiction disorders.

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Groundbreaking ketamine study receives approval for expansion

The groundbreaking study will now be expanded to explore the use of ketamine for treating binge eating disorder, compulsive sexual behaviour and internet gaming disorder.

Awakn Life Sciences is carrying out the world’s first study exploring the use of ketamine-assisted psychedelic therapy to treat gambling addiction. The study has now received ethical committee approval to include an additional three addictive disorders.

There are currently no licensed pharmacological treatments for behavioural addictions or disorders available, meaning there is a vital need to find new and effective treatment options.

The basket study is led by professor Celia Morgan, Awakn’s head of ketamine-assisted therapy for addiction, professor of psychopharmacology at the University of Exeter, and an internationally respected expert in the therapeutic use of ketamine.

See also  Awakn initiates first ever ketamine treatment study for gambling addiction

Morgan commented: “We are delighted to expand this research and to make further inroads into a treatment area that has had no material pharmacological advancements in far too long, all the while the number of people suffering has steadily increased.

“We hope this will give us valuable insights to push our ketamine programme forward and help these people as quickly as possible.”

Morgan’s work will investigate a new treatment approach for these behavioural addictions, trying to harness a window in which the brain is able to make new connections. The study will explore and monitor whether ketamine can increase neuroplasticity using electroencephalogram (EEG).

See also  Awakn’s second psychedelic therapy clinic to open in London 

The global populations affected by behavioural addictions are huge – with binge eating disorder affecting up to 110 million people; internet gaming disorder affecting 238 million; sexual compulsive behaviour affecting up to 350 million; and gambling disorder up to 450 million people.

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