New York State Psychiatric Institute

Vistagen Announces Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder

Retrieved on: 
Monday, August 7, 2023

The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015).

Key Points: 
  • The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015).
  • The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale (p=0.033).
  • Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials.
  • “As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas.

Vistagen Provides Corporate Update and Reports Fiscal Year 2023 Financial Results

Retrieved on: 
Wednesday, June 28, 2023

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today provided a corporate update and reported financial results for its fiscal year 2023 ended March 31, 2023.

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today provided a corporate update and reported financial results for its fiscal year 2023 ended March 31, 2023.
  • Positive results reported from Phase 2A study of PH80 in women diagnosed with vasomotor symptoms (hot flashes) due to menopause.
  • Vistagen will host a conference call and live audio webcast this afternoon at 4:30 p.m. Eastern Time to provide a corporate update for its fiscal year 2023 ended March 31, 2023.
  • In addition, a telephone playback of the call will be available after approximately 8:00 p.m. Eastern Time on Wednesday, June 28, 2023.

New Study Finds At Least Twice as Many US Adults Experience Schizophrenia Spectrum Disorders Than Previously Thought

Retrieved on: 
Tuesday, June 27, 2023

Schizophrenia spectrum disorders include schizophrenia, schizoaffective disorder and schizophreniform disorder.

Key Points: 
  • Schizophrenia spectrum disorders include schizophrenia, schizoaffective disorder and schizophreniform disorder.
  • "The MDPS finding that schizophrenia spectrum disorders may be more prevalent than previously thought is especially important," said Heather Ringeisen , Ph.D., vice president, health of populations at RTI and principal investigator of the project.
  • "People with a schizophrenia spectrum disorder experience high levels of disability that present significant challenges in all aspects of their life."
  • Treatments for schizophrenia spectrum disorders exist but not all people who are diagnosed receive effective treatment.

FDA Provides Positive Feedback to Vistagen Regarding Use of the Liebowitz Social Anxiety Scale (LSAS) as an Endpoint in Phase 3 Development of Fasedienol (PH94B) for Treatment of Social Anxiety Disorder

Retrieved on: 
Thursday, March 30, 2023

“With positive feedback from the FDA, we’re focused on advancing a clinical study design with the Liebowitz Social Anxiety Scale as the primary endpoint to study the real-world effects of fasedienol over time,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • “With positive feedback from the FDA, we’re focused on advancing a clinical study design with the Liebowitz Social Anxiety Scale as the primary endpoint to study the real-world effects of fasedienol over time,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • “This is an important step forward, especially as SAD is becoming even more prevalent in a post-COVID world.
  • Dr. Liebowitz was among the clinical investigators involved in the registrational efficacy trials for all of these drugs, and all of such registrational trials were positive.
  • Results of the AjDA study may provide support for an as-needed (PRN) fasedienol dosing approach over time as the preferred mode of treatment.

Pharma Consortium Publishes Results of Large EEG/ERP Biomarker Study in Subjects with Schizophrenia and Healthy Volunteers

Retrieved on: 
Thursday, March 16, 2023

LOUISVILLE, Ky., March 16, 2023 /PRNewswire/ -- The ERP Biomarker Qualification Consortium announced today the publication of all data ( https://doi.org/10.1016/j.schres.2023.02.018 ) from a large biomarker study of subjects with schizophrenia and matched healthy volunteers.

Key Points: 
  • LOUISVILLE, Ky., March 16, 2023 /PRNewswire/ -- The ERP Biomarker Qualification Consortium announced today the publication of all data ( https://doi.org/10.1016/j.schres.2023.02.018 ) from a large biomarker study of subjects with schizophrenia and matched healthy volunteers.
  • The study ( EBS-A ) was performed with 161 subjects, 80 who met the clinical criteria for schizophrenia and 81 subjects who were matched for age and gender.
  • Each study participant made three visits to one of four clinical study sites.
  • The published results include a large number of EEG/ERP parameters that equal or exceed the quality of results reported from top academic centers.

Vistagen Announces Completion of Last Patient, Last Visit in Phase 2 Clinical Trial of PH94B for the Treatment of Adjustment Disorder with Anxiety

Retrieved on: 
Tuesday, January 10, 2023

The exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults.

Key Points: 
  • The exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults.
  • The primary endpoint is the change from baseline in anxiety level as measured by the Hamilton Anxiety Rating Scale (HAM-A) at the end of Week 4 of treatment with PH94B or placebo.
  • This is a major milestone for our team,” stated Shawn Singh, Chief Executive Officer of Vistagen.
  • Vistagen is dedicated to developing treatments to address the escalating mental health crisis.

Karl J. Schroeder, MD is being recognized by Continental Who's Who

Retrieved on: 
Thursday, July 14, 2022

SUFFERN, N.Y., July 14, 2022 /PRNewswire/ -- Karl J. Schroeder, MD is being recognized by Continental Who's Who as a Lifetime Achiever for his distinguished career in the Psychiatry field and in acknowledgment of his work in private practice.

Key Points: 
  • SUFFERN, N.Y., July 14, 2022 /PRNewswire/ -- Karl J. Schroeder, MD is being recognized by Continental Who's Who as a Lifetime Achiever for his distinguished career in the Psychiatry field and in acknowledgment of his work in private practice.
  • He has provided excellent patient care in private practice at 104 Montebello Road in Suffern, NY, for over 46 years.
  • Before working in private practice, Dr. Schroeder obtained his college education at Notre Dame, where he received his undergraduate degree.
  • Dr. Schroeder has been recognized for his decades of work by IssueWire and Health News Today, who released his profiles in 2021.

RubiconMD Welcomes Behavioral Health Medical Director, Ludwing Salamanca, MD, PhD

Retrieved on: 
Wednesday, May 11, 2022

RubiconMD, the market leader for virtual specialty eConsults announced today that Ludwing Salamanca, MD, PhD will be joining the organization as their first-ever Behavioral Health Medical Director.

Key Points: 
  • RubiconMD, the market leader for virtual specialty eConsults announced today that Ludwing Salamanca, MD, PhD will be joining the organization as their first-ever Behavioral Health Medical Director.
  • He has been a consultant for the RubiconMD platform for the last three years and leads quarterly behavioral health care CME webinars.
  • He will develop a long-term strategy to continually grow the behavioral health team, recruiting top psychiatrists from around the US.
  • It has been amazing to witness the transformation that RubiconMD has made from eConsults to supporting longitudinal behavioral health through collaborative care.

Corcept Therapeutics Completes Enrollment in Phase 2 GRATITUDE Study of Miricorilant in Patients with Antipsychotic-Induced Weight Gain

Retrieved on: 
Monday, April 4, 2022

GRATITUDE is evaluating the efficacy, pharmacokinetics and safety of miricorilant among adult patients with schizophrenia or bipolar disorder and recent antipsychotic-induced weight gain.

Key Points: 
  • GRATITUDE is evaluating the efficacy, pharmacokinetics and safety of miricorilant among adult patients with schizophrenia or bipolar disorder and recent antipsychotic-induced weight gain.
  • Patients were randomized 1:1 to receive either 600 milligrams of miricorilant or placebo each day, in addition to their established dose of antipsychotic medication, for 12 weeks.
  • Earlier this year, Corcept completed enrollment in a second study, GRATITUDE II, which is evaluating miricorilant as a treatment for long-standing antipsychotic-induced weight gain.
  • The primary endpoint in both GRATITUDE and GRATITUDE II is reduction in body weight compared to patients receiving placebo.

Brain & Behavior Research Foundation Awards 2021 Outstanding Achievement Prizes to Nine Leading Psychiatric Researchers

Retrieved on: 
Wednesday, October 20, 2021

New York, Oct. 20, 2021 (GLOBE NEWSWIRE) -- The Brain & Behavior Research Foundation (BBRF), the worlds largest private funder of mental health research grants, today announced that it is awarding its 2021 Outstanding Achievement Prizes in Mental Health to nine scientists for their extraordinary work in advancing psychiatric research.

Key Points: 
  • New York, Oct. 20, 2021 (GLOBE NEWSWIRE) -- The Brain & Behavior Research Foundation (BBRF), the worlds largest private funder of mental health research grants, today announced that it is awarding its 2021 Outstanding Achievement Prizes in Mental Health to nine scientists for their extraordinary work in advancing psychiatric research.
  • The Outstanding Achievement Prizes acknowledge and celebrate the power and importance of neuroscience and psychiatric research in transforming the lives of people living with mental illness, said Jeffrey Borenstein, M.D., President & CEO of the Brain & Behavior Research Foundation.
  • We celebrate and honor the 2021 Outstanding Achievement Prizewinners for their scientific accomplishments and exceptional achievements in brain and behavior research, said Herbert Pardes, M.D., President of the Brain & Behavior Research Foundations Scientific Council.
  • The Brain & Behavior Research Foundation awards research grants to develop improved treatments, cures, and methods of prevention for mental illness.