Regulatory Alignment of Psilocybin Clinical Trials in Major Depressive Disorder on ClinicalTrials.gov: A Cross-Sectional Analysis

Pharmacopsychiatry, Год журнала: 2025, Номер unknown

Опубликована: Апрель 17, 2025

Abstract Regulatory compliance is crucial in the clinical development of psychedelic substances, including psilocybin. This study aimed to examine alignment trial protocols for psilocybin treatment major depressive disorder (MDD) and treatment-resistant depression (TRD) with established regulatory requirements. A cross-sectional investigation was conducted on ClinicalTrials.gov using keywords: “Psilocybin” “Psilocin” identify interventional studies posted protocols. Only MDD TRD were included. Data extraction focused key aspects, safety, functional unblinding, expectancy bias, distribution investigational medical products. Eleven identified, four meeting inclusion criteria. The most commonly studied dose 25 mg. Two trials double-blind. Although analyzed superficially adhered requirements, there gaps addressing potential drug interactions, acute chronic concurrent use antidepressants, prohibited medications. Certain such as unblinding or did not share all pathways. Risk mitigation strategies primarily based external Patients bipolar spectrum disorders schizoaffective excluded. underscores importance conducting psychedelics strict adherence standards. Future research should focus improving exploring efficacy broader patient populations.

Язык: Английский

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Advances in the Study of NMDA Receptors in Depression Pathogenesis and the Antidepressant Efficacy of Their Antagonists

Asian Journal of Psychiatry, Год журнала: 2025, Номер 108, С. 104502 - 104502

Опубликована: Апрель 19, 2025

Язык: Английский

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S-ketamine ameliorates post-stroke depression in mice via attenuation of neuroinflammation, synaptic restoration, and BDNF pathway activation

Biochemical and Biophysical Research Communications, Год журнала: 2025, Номер unknown, С. 151965 - 151965

Опубликована: Май 1, 2025

Язык: Английский

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Effect of oral tryptamines on the gut microbiome of rats—a preliminary study

PeerJ, Год журнала: 2024, Номер 12, С. e17517 - e17517

Опубликована: Июнь 3, 2024

Background Psilocybin and related tryptamines have come into the spotlight in recent years as potential therapeutics for depression. Research on mechanisms of these effects has historically focused direct drugs neural processes. However, addition to such effects, alterations peripheral physiology may also contribute their therapeutic effects. In particular, substantial support exists a gut microbiome-mediated pathway antidepressant efficacy other drug classes, but no prior studies determined microbiota. Methods To address this gap, preliminary study, male Long Evans rats were treated with varying dosages oral psilocybin (0.2 or 2 mg/kg), norbaeocystin (0.25 2.52 vehicle fecal samples collected 1 week 3 weeks after exposure microbiome analysis using integrated 16S ribosomal DNA sequencing determine composition. Results We found that although treatment neither nor significantly affected overall diversity, it did cause significant dose- time-dependent changes bacterial abundance at phylum level, including increases Verrucomicrobia Actinobacteria , decreases Proteobacteria . Conclusion Implications These findings idea act manner, potentially identifying novel mechanism activity. The results from study suggest warrant further investigation antidepressant, given similarity its psilocybin.

Язык: Английский

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Design, synthesis, and antitumor activity evaluation of BF3-o, m, p-phenylenediamine bridged with pyrimidine-indole BF3 adduction derivatives

Molecular Diversity, Год журнала: 2024, Номер 29(1), С. 425 - 437

Опубликована: Июль 19, 2024

Язык: Английский

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Major challenges in youth psychopathology: treatment-resistant depression. A narrative review

Frontiers in Psychiatry, Год журнала: 2024, Номер 15

Опубликована: Июль 11, 2024

Major depressive disorder (MDD) represents a major health issue in adolescents and young adults, leading to high levels of disability profoundly impacting overall functioning. The clinical presentation MDD this vulnerable age group may slightly differ from what can be observed adult populations, psychopharmacological strategies do not always lead optimal response. Resistance antidepressant treatment has prevalence estimated around 40% youths suffering is associated with higher comorbidity rates suicidality. Several factors, encompassing biological, environmental, features, contribute the emergence treatment-resistant depression (TRD) adults. Furthermore, TRD underpin presence an unrecognized bipolar diathesis, increasing complexity picture posing differential diagnosis challenges practice. After summarizing current evidence on epidemiological correlates present review also provides overview possible strategies, including novel fast-acting antidepressants. Despite these pharmacological agents are promising population, their usage expected rely risk-benefit ratio considered context integrated models care.

Язык: Английский

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LT-102, an AMPA receptor potentiator, alleviates depression-like behavior and synaptic plasticity impairments in prefrontal cortex induced by sleep deprivation

Journal of Affective Disorders, Год журнала: 2024, Номер 367, С. 18 - 30

Опубликована: Авг. 29, 2024

Язык: Английский

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Adenosine A2A signaling in mood disorders: how far have we come?

IBRO Neuroscience Reports, Год журнала: 2024, Номер unknown

Опубликована: Сен. 1, 2024

Язык: Английский

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Tryptamines and Mental Health: Activating the 5-HT Receptor for Therapeutic Potential

ACS Medicinal Chemistry Letters, Год журнала: 2023, Номер 14(10), С. 1331 - 1333

Опубликована: Сен. 15, 2023

Tryptamines, a class of 3-aminoethyl-indoles that activate the serotonin receptor, show potential for novel mental health treatments. The FDA has granted "breakthrough therapy designation" to psilocybin and MDMA treatment-resistant depression, major depressive disorder, post-traumatic stress sparking global research efforts. Various clinical trials are currently investigating therapeutic value several disorders. Results thus far indicate significant improvements in patient-reported outcomes via reductions experiential avoidance. These advancements highlight promising future tryptamines therapy.

Язык: Английский

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Electroconvulsive seizures regulate various stages of hippocampal cell genesis and mBDNF at different times after treatment in adolescent and adult rats of both sexes

Frontiers in Molecular Neuroscience, Год журнала: 2023, Номер 16

Опубликована: Окт. 30, 2023

Electroconvulsive therapy, a fast-acting option for treatment-resistant depression, is modeled at the preclinical level through induction of electroconvulsive seizures (ECS) in rodents. Recent studies from our group proved sex- and age-differences antidepressant-like response elicited by ECS rats; while an was observed male adolescent adult rats (although with greater efficacy adulthood), same parameters rendered inefficacious females any age. To better understand potential sex differences taking place molecular that might be mediating these behavioral disparities, we evaluated impact repeated treatment (95 mA 0.6 s, 100 Hz, ms) both sexes. Several hippocampal markers neuroplasticity, commonly regulated most antidepressants, such as those neurogenesis (cell proliferation, neurogenic differentiation, long-term cell survival) or mBDNF associated signaling (e.g., mTOR ERK1/2) were different time-points after (1-, 8-, 15- up to 30-days post-treatment). The main results demonstrated improved survival rate new cells born dentate gryus before treatment. Moreover, increased proliferation differentiation times post-treatment, paired persistent increases mBDNF, long In general, effects each varied age animal (adolescent vs. adulthood). present study first-one demonstrate changes induced hippocampus, some them also occurred female adolescence. Although could not justify lack described (vs. rats), they proposed certain beneficial common sexes, periods studied, opening avenue further studies. Based on neurochemical effects, should have displayed similar efficacies biological Therefore, reason behind disparities explored translate efficacious treatments specific and/or personalized clinic.

Язык: Английский

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