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).
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.
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.”
Review of evidence confirms ketamine reduces suicidal thoughts
A systematic review of all evidence relating to ketamine therapy has been carried out.
A review has shown that ketamine therapy is able to rapidly reduce symptoms of depression and suicidal thoughts in the short-term.
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.
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.”
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.
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.
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.
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.
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).
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.
First-of-its-kind trial investigates simultaneous administration of psilocybin
Results have shown that 10mg or 25mg doses of psilocybin have no detrimental effects.
Results from a new study have demonstrated that 10mg or 25mg doses of psilocybin have no long- or short-term detrimental effects in healthy individuals.
In an essential first step in demonstrating the safety and feasibility of psilocybin, a new study has shown the compound can be safely administered in 10mg or 25mg doses to up to six participants simultaneously.
The study is the first of its kind to investigate the simultaneous administration of psilocybin for use within controlled settings alongside talking therapy as a potential treatment for conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD).
The research, from the Institute of Psychiatry, Psychology, & Neuroscience (IoPPN) at King’s College London, carried out in partnership with UK company COMPASS Pathways, has been published in The Journal of Psychopharmacology.
National Institute for Health Research clinical scientist, Dr James Rucker, is the study’s lead author from IoPPN, and is honorary consultant psychiatrist at South London and Maudsley NHS Foundation Trust.
Rucker commented: “This rigorous study is an important first demonstration that the simultaneous administration of psilocybin can be explored further.
“If we think about how psilocybin therapy (if approved) may be delivered in the future, it’s important to demonstrate the feasibility and the safety of giving it to more than one person at the same time, so we can think about how we scale up the treatment.
“This therapy has promise for people living with serious mental health problems, like TRD and PTSD. They can be extremely disabling, distressing and disruptive, but current treatment options for these conditions are ineffective or partially effective for many people.”
Early research indicates psilocybin therapy as potentially efficacious for the treatment of such conditions, however, so far, no trials have been undertaken at the scale needed for regulatory approval to make the therapy available.
CMO at COMPASS, professor Guy Goodwin, added: “This study was an early part of our clinical development programme for COMP360 psilocybin therapy.
“It explored the safety and feasibility of simultaneous psilocybin administration, with 1:1 support, in healthy participants, and provided a strong foundation to which we have now added positive results from our phase IIb trial in 233 patients with TRD, and from our open-label study of patients taking SSRI antidepressants alongside psilocybin therapy.
“We are looking forward to finalising plans for our phase III programme, which we expect to begin in Q3 2022.”
The investigators have since completed Phase II of the study, which has explored the efficacy and safety of psilocybin in people living with TRD and PTSD, and are currently analysing the data.
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