At Day 21, low-dose ketamine KET01 shows no statistical edge over placebo.

Ketabon GmbH revealed positive top-line results from its phase 2 KET01-02 study investigating KET01, an oral slow-release formulation of oral ketamine, for treatment-resistant depression (TRD). Results were promising initially. Investigators noted improvements in depression severity as early as day 4, but data were not statistically significant over placebo at day 21.

A look at Ketabon GmbH’s KET01-02 study in treatment-resistant depression

The trial studied KET01 doses of 120 mg and 240 mg per day. It involved 122 individuals who were outpatients with current major depressive episodes not responding to at least two standard antidepressants. Participants received KET01 once daily in addition to a traditional antidepressant treatment over the three-week period. In particular, the 240 mg/day dose showed clinically relevant improvements with statistical significance versus placebo on days 4 and 7. The drug, however, did not maintain significance at day 21.


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Beyond the trip with non-hallucinogenic psychoplastogens in neuropsychiatry

Interest in ketamine and psilocybin as potential therapies for mood disorders has surged since around 2010. A groundbreaking 2000 study at Yale revealed the powerful antidepressant effects of ketamine, a dissociative anesthetic. Unlike traditional antidepressants which can take weeks or months to have an impact, a single dose of ketamine led to significant improvements in depressive symptoms in as little as 72 hours.

Structural neuroplasticity and non-hallucinogenic psychoplastogens

This revelation, which Kurt Rasmussen, chief scientific officer of Delix, describes as a “watershed development” in neuropsychiatry, sparked a new understanding of the brain’s capacity for rapid structural neuroplasticity. Essentially, drugs like ketamine can prompt the brain to form new neural connections quickly, a process known as synaptogenesis. “Neuron damage is a component of many different disease states,” Rasmussen noted. “And the discovery of ketamine’…

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The future of rapid and enduring neuropsychiatric treatments: From psychedelics to non-hallucinatory psychoplastogens

Serotonin molecule [Vladimir/Adobe Stock]

Neuropsychiatric disorders, such as depression and anxiety, are among the leading causes of disability worldwide. Almost one billion people globally — roughly one out of eight individuals — live with a mental disorder, with anxiety and depressive disorders the most common, according to the World Health Organization. Yet current therapies such as selective serotonin reuptake inhibitors (SSRIs) offer limited efficacy and come with undesirable side effects. Additionally, they may take weeks to produce noticeable benefits.

These challenges have sparked interest in alternative treatments, including psychedelics and psychoplastogens, for mental health treatment, as noted by Dr. Kurt Rasmussen, Delix‘s chief scientific officer. “There are now a lot of researchers looking at psychoplastogens as a way to help remodel those circuits and treat depression and anxiety mor…

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How should ketamine be used for depression? 

[Image courtesy of PubChem]

Proponents of ketamine for depression describe its remarkable ability to catalyze improvements in many patients’ mood disorders such as depression and anxiety.

However, the question of how the dissociative anesthetic ketamine should be used in the long-term to manage mood order symptoms is less clear.

Pharma efforts in ketamine for depression

First synthesized in 1962, ketamine’s patent expired in 2002. Janssen, however, managed to secure patent protection for Spravato, the S-enantiomer of ketamine that won FDA approval in 2019.

Janssen has not disclosed sales figures for its nasal spray-based Spravato, but GlobalData projects it will generate global sales of roughly $383 million by 2029.

Seelos Therapeutics, is developing intranasal racemic ketamine for acute suicidal ideation and behavior in patients with major depressive disorder (MDD). The company …

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How effective is ketamine for depression? 

[Image by Lucija Rasonja from Pixabay]

First synthesized in 1962, the dissociative anesthetic ketamine is rapidly growing in popularity for its off-label use in treating depression and mood disorders. In recent years, hundreds of clinics across the U.S. have begun offering ketamine for depression, anxiety and other mood disorders.  

The surge in interest has also attracted startups such as Mindbloom and Field Trip Health. At the same time, Janssen (NYSE:JNJ) scored FDA approval for the ketamine enantiomer Spravato (esketamine) for depression in 2019. 

Impressive but limited data

While evidence is building that indicates that ketamine is effective against depression, the level of evidence is frequently limited to small clinical trials, case reports and anecdotes. “It’s really difficult to tease apart what’s happening in these [ketamine] studies because there’s no standard protocol,&…

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Ketamine research on the upswing for severe depression

Interest in the dissociative anesthetic ketamine continues to be strong as a therapy for treatment-resistant depression and similar conditions.

But the enthusiasm surrounding the drug is likely higher than the quality of evidence supporting its use to treat severe depression.

Research into the drug’s potential to treat depression, however, is ramping up.

One recent small study published in the Journal of Clinical Psychiatry found that a single dose of the drug reduced the severity of depression in individuals with suicidal ideation.

The study administered intravenous ketamine to 39 participants and midazolam, a benzodiazepine, to another 39. Investigators administered ketamine at relatively low dose levels where it did not have an anesthetic effect.

The blinded study also found that the drug made patients feel safer, and it also quickly improved neurocognition. In addition, it provided persistent therapeutic effects for up to six weeks afte…

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What the ketamine boom could mean for pharma

Photo by Alex Green from Pexels

The demand for ketamine has surged in recent years as interest in its off-label use for treating depression, anxiety and PTSD has grown.

Ketamine has been “shown to be very effective,” said Linnea Butler, founder and CEO of Bay Area Mental Health (Campbell, California), which recently began offering ketamine-assisted psychotherapy.

Also this week, Earlier this week, Pasithea Therapeutics Corp. (NSDQ:KTTA), announced the launch of the first U.K.-based ketamine infusion clinic.

And separately, Delic Holdings (CSE: DELC) announced two new alliances between Ketamine Wellness Centers (KWC) and the Veterans Administration Community Care Networks of Illinois and Minnesota. KWC plans to provide ketamine for PTSD, depression and chronic pain to veterans at no out-of-pocket cost at their locations in Naperville, Illinois, and Burnsville, Minnesota.

Parke-Davis, now …

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