Bipolar II disorder

• BALTIMORE, Dec. 6, 2023 /PRNewswire/ -- JAMA Psychiatry recently published a first-of-its-kind clinical trial conducted at Sheppard Pratt studying the efficacy and safety of a single dose of synthetic psilocybin accompanied by psychotherapy in treating individuals with treatment-resistant bipolar type II disorder (bipolar II).
• The study revealed promising results with 80% of participants meeting remission criteria 12 weeks after treatment.
• The results of this study suggest the efficacy and safety of psilocybin in treatment of bipolar II depression, but cannot be extrapolated to the study of psilocybin to treat bipolar I disorder.
• Sheppard Pratt's Center of Excellence for Psilocybin Research and Treatment is currently conducting clinical trials on psilocybin with psychotherapy for the treatment of anorexia, treatment-resistant depression and chronic suicidal ideation.

• Around 2% of the adult population have a bipolar disorder.
• Certain medications may be more beneficial for certain types of bipolar disorder, but how do you know which “type” you or a loved one has?
• A new approach is needed that places emphasis on “real-world” effectiveness and respects the observations of people with bipolar disorder.

Two types of bipolar disorder

• Originally called “manic-depressive psychosis”, it is now known as bipolar I disorder.
• In the mid-1990s, bipolar II disorder was defined.
• Both bipolar I and bipolar II are marked by pronounced mood swings.
• The key distinguishing feature between the two bipolar conditions is the presence of psychotic features (delusions and/or hallucinations) in those with bipolar I.

Current treatments

• Melbourne psychiatrist John Cade discovered the effectiveness of lithium as a treatment for manic depression in 1949.
• This landmark research ushered in the era of condition-specific psychopharmacology.
• Practitioners refer to research-based guidelines to determine the best medications to help stabilise a bipolar disorder.

But evidence isn’t everything

• All were “evidence-based”, but we found minimal agreement between them, thus raising questions about their validity.
• New guidelines have been published since then but the trend for minimal agreement continues.
• Assessing a psychiatric evidence base is difficult.

Accounting for side effects

• However, it has multiple side effects.
• But 50% of the completers receiving lithium experienced distinctive cognitive impairment – side effects that affected their thinking and reasoning.
• Many of the antipsychotic drugs nominated in guidelines also have major side effects, including weight gain and diabetes.
• People who are stable while taking these medications without major side effects should not be alarmed.

We want to hear from people with bipolar disorders

All these concerns highlight the need for research focused on “real-world” samples to determine the best treatments that consider each person’s responses to any medication. We are conducting such a study now, in collaboration with the Black Dog Institute. If you are interested, you can access the study here. Gordon Parker receives funding from the Australian National Health and Medical Research Council.

• The trial was designed to evaluate the safety and tolerability of repeat dosing of BXCL501 in healthy volunteers as a single agent and in combination with antidepressant duloxetine.
• “This positive outcome supports the potential market expansion opportunity for our lead asset, BXCL501, into chronic neuropsychiatric disorders,” said Vimal Mehta, CEO of BioXcel Therapeutics.
• We believe these new data present a transformative opportunity beyond acute treatment for the BXCL501 program, including treatment for MDD.
• The study’s primary objectives were to assess the safety, tolerability, and pharmacokinetics of BXCL501 in healthy volunteers in multiple ascending doses.

• NEW HAVEN, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, additional members of the management team, and other BioXcel team members will ring the closing bell of the Nasdaq Stock Market today, Tuesday, February 21, 2023.
• “At BioXcel Therapeutics, we are building a disruptive biopharmaceutical business model to successfully drive accelerated AI-enabled drug development and commercialization,” said Dr. Mehta.
• In addition, we look forward to market-expansion opportunities for our overall neuropsychiatric program, with two pivotal study readouts planned for BXCL501 in the first half of 2023.
• As BioXcel advances its lead drug candidates in two therapeutic areas, we appreciate Nasdaq’s recognition of our progress through today’s closing bell ceremony.”
  The ceremony will take place at the Nasdaq MarketSite, 4 Times Square, New York, beginning at 3:45 PM ET.