Breakthrough Clinical Results
Vistagen, a clinical-stage biopharmaceutical company, announced it will present at the 2025 American Society of Clinical Psychopharmacology (ASCP) Conference. Presentations will cover new insights into social anxiety disorder (SAD) from fasedienol clinical trials, and the impact of itruvone, an investigational pherine for major depressive disorder, on nasal chemosensory receptors and olfactory bulb activity. Itruvone is a novel intranasal therapy designed to activate olfactory bulb-to-brain neurocircuits without requiring absorption into the blood or brain.
Key Highlights
- Vistagen will present at the 2025 ASCP Conference.
- Presentations will focus on fasedienol (for social anxiety disorder) and itruvone (for major depressive disorder).
- Data will explore the age of onset of SAD and itruvone's impact on nasal chemosensory receptors and olfactory bulb activity.
- Itruvone is a novel intranasal therapy with a unique mechanism of action.
Incidence and Prevalence
Global Estimates of Major Depressive Disorder
Depression affects approximately 350 million people worldwide and is the world's leading cause of disability.
Prevalence in Specific Populations
Nursing Students
A high pooled prevalence of depression of 34.0% was reported among nursing students. Depression prevalence varies by age group, with a higher prevalence noted in younger nursing students (41.0%). Geographic differences exist, with Asian nursing students experiencing a higher prevalence of depression (43.0%).
Heart Failure Patients
Major depression and other depressive disorders are common in heart failure patients and have adverse effects on functional status, quality of life, and prognosis.
Surgical Patients
Research found that 13% of surgical patients in a community hospital had current major depression.
Trajectories of Depressive Symptoms
A study of 7810 individuals identified five trajectories of depressive symptoms: - Non-depressed (36.7%) - Mild (48.8%) - Worsening (7.8%) - Improving (4.1%) - Persistent (2.7%)
Related Mental Health Conditions
The lifetime prevalence for any anxiety disorder is almost 30%. Economic costs associated with anxiety disorders are large - €48 billion over 28 European countries - and similar to those for dementia.
Emerging Mechanism of Action
Emerging Mechanisms of Action for Major Depressive Disorder
Recent publications highlight several important mechanisms of action (MoA) for Major Depressive Disorder (MDD) treatment and pathophysiology.
Neurotransmitter Systems
Monoamine neurotransmitters remain central to MDD pathophysiology, with serotonin (5-hydroxy tryptamine, 5-HT) playing a predominant role. Dopamine (DA) and norepinephrine (NE) are also major neurotransmitters involved in depression.
Serotonin receptor antagonists (5-HTRA) have emerged as particularly important: - They inhibit binding of serotonin to postsynaptic 5-HTR - This increases serotonin availability to other receptors (5-HT₁, 5-HT₂, and 5-HT₄) - These changes produce anti-depressant-like effects - 5-HTRA have important roles in mood and stress disorders
Pharmacological Advances
Desvenlafaxine has shown promise as an effective antidepressant with: - Favorable safety and tolerability profile in adults - Particular effectiveness in peri- and post-menopausal women with MDD - Relatively low potential for drug-drug interactions - Potential suitability for patients with comorbid physical illnesses
Neurophysiological Mechanisms
Abnormal EEG neural oscillations reflect cortical imbalance in MDD: - First-episode patients show higher relative power of low delta and theta bands in right occipital region - Lower relative power of alpha band in posterior occipital region - Lower alpha band scalp functional connectivity - Higher gamma band scalp functional connectivity - The relative power of alpha band in left parietal region represents a potential objective electrophysiological indicator
Molecular Mechanisms
MicroRNAs (miRNAs) are emerging as important factors in MDD pathophysiology: - miRNA expression is down-regulated in frontal cortex of depressed suicide subjects - Enoxacin, which enhances miRNA production, decreased learned helpless behavior in rats
Neural Network Dysfunction
The default mode network (DMN) shows abnormal patterns in melancholic MDD: - Patients show low network homogeneity values in right middle temporal gyrus and temporal pole
Non-Pharmacological Approaches
Physical activity interventions demonstrate promising therapeutic effects: - Continuous endurance training - Explosive interval training - Resistance strength training - Mind-body training
These physical interventions improve symptoms and show positive effects on cognitive function, sleep status, and brain plasticity.
Drug used in other indications
Based on the context provided, Itruvone (desvenlafaxine) is being trialled for several indications other than Major Depressive Disorder (MDD), including:
- Vasomotor symptoms of menopause
- Anxiety symptoms
- Painful physical symptoms
The context does not provide specific information about the intervention models for these trials beyond MDD.
Additional information about desvenlafaxine indicates that it is a serotonin-norepinephrine reuptake inhibitor (SNRI) developed by Wyeth. It is a novel salt form of the isolated major active metabolite of the antidepressant venlafaxine.
Desvenlafaxine has already been approved by the US FDA for the treatment of major depressive disorder based on randomized, double-blind, placebo-controlled clinical trials.
A notable characteristic of desvenlafaxine is that unlike various other antidepressants including venlafaxine, it is not metabolized by cytochrome p450 (CYP) enzyme pathways and is associated with minimal inhibition of CYP enzymes. This feature results in a comparatively low risk of drug-drug interaction and consistent intra-individual and inter-individual pharmacokinetic profiles.