A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).

Start Date02 Mar 2023

Sponsor / Collaborator

Tonix Pharmaceuticals, Inc.

[+1]

NCT03380728 / Enrolling by invitationPhase 2IIT

Tolerability and Efficacy of Ibogaine in the Treatment of Alcoholism: the First Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial

Approximately 5% of the world's adult population has some alcohol-related disorder, which in addition is associated with 3% of all deaths in the world. In Brazil, harmful use and dependence on alcohol reach about 10% of the population, with alcohol being one of the main factors of disease and mortality. Although the medications currently used have some efficacy, the adverse effects and relatively long time of treatment are factors that may reduce patients' motivation to continue taking the medication correctly. Therefore, it is necessary to conduct research with new drugs for the treatment of alcoholism. Ibogaine is an alkaloid present in the bush Tabernanthe iboga (iboga), a plant from Central Africa traditionally used in countries such as Gabon and Cameroon. Animal studies and case series suggest that one or a few doses of ibogaine significantly reduce withdrawal symptoms and the intensity of use of various drugs, including opioids, psychostimulants, and alcohol. However, there are no controlled clinical studies that have explored these effects. The aim of the present study is to evaluate the safety, tolerability and efficacy of increasing doses of ibogaine in 12 alcoholic patients. Each patient will be hospitalized for 20 days and receive 3 increasing doses of ibogaine. The first 3 patients will receive oral doses of 20 to 400 mg of ibogaine in an open-label design. If the 3 higher doses (240, 320 and 400 mg) are well tolerated, the next 9 volunteers will receive these doses or placebo randomly. The volunteers will also be evaluated 7, 14 and 21 days and 1, 3, 6 and 12 months after leaving the hospital to monitor the consumption of alcohol and other drugs.

Start Date30 Oct 2022

Sponsor / Collaborator

University of Sao Paulo

[+2]

NCT04313712 / Active, not recruitingNot ApplicableIIT

A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans With Sequelae of Repeated Blast Exposure

A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans with Sequelae of Repeated Blast Exposure.

Start Date15 Nov 2021

Sponsor / Collaborator

Stanford University

100 Clinical Results associated with Opioid receptors x SERT

100 Translational Medicine associated with Opioid receptors x SERT

0 Patents (Medical) associated with Opioid receptors x SERT

Literatures (Medical) associated with Opioid receptors x SERT

01 Feb 2024·Health Science Reports

Comprehensive analysis of pain genes in prognosis of kidney renal clear cell carcinoma and tumor immunotherapy: A comprehensive bioinformatic study

Article

Author: Lin, Shu‐Bin ; Li, Ming ; Yin, Jun ; Yang, Zheng‐Liang ; Zhuang, Xiao‐Yu ; Xu, Da‐Ming ; Xu, Teng‐Yu

AbstractBackgroundThe effect of pain genes (NAV1, EHMT2, SP1, SLC6A4, COMT, OPRM1, OPRD1, CYP2D6, and CYP3A4) have not been reported previously in kidney renal clear cell carcinoma (KIRC) patients and thus we made a comprehensive analysis of pain genes in the prognosis of KIRC and tumor immunotherapy.MethodsIn this study, TCGA, Kaplan–Meier plotter, Metascape, STRING, Human Protein Atlas, Single Cell Expression Atlas database, LinkedOmics, cBioPortal, MethSurv, CancerSEA, COSMIC database and R package (ggplot2, version 3.3.3) were used for comprehensive analysis of pain genes in KIRC. Pearson and Spearman correlation coefficients were for co‐expression analysis. Immunotherapy and TISIDB database were used for tumor Immunotherapy.ResultsRepresentative pain genes (SP1, SLC6A4, COMT, OPRD1, CYP2D6, and CYP3A4) were statistically significant (p < 0.0001) in the prognosis of KIRC. Immunotherapy (anti‐PD‐1 therapy, anti‐PD‐L1 therapy, and anti‐CTLA4 therapy) and immunomodulator (immunoinhibitor, immunostimulator, and MHC molecule) in KIRC were significant associated with pain genes (SP1, SLC6A4, COMT, OPRD1, CYP2D6, and CYP3A4), which were the important addition to clinical decision making for patients.ConclusionsOur study uncovered a mechanism for the effect of pain genes on KIRC outcome via the modulation of associated co‐expression gene networks, gene variation, and tumor Immunotherapy.

01 Nov 2023·Obesity reviews : an official journal of the International Association for the Study of Obesity

Effects of bariatric surgery and dietary interventions for obesity on brain neurotransmitter systems and metabolism: A systematic review of positron emission tomography (PET) and single-photon emission computed tomography (SPECT) studies.

Review

Author: Miras, Alexander D ; Al-Alsheikh, Alhanouf S ; Alabdulkader, Shahd ; Goldstone, Anthony P

This systematic review collates studies of dietary or bariatric surgery interventions for obesity using positron emission tomography and single-photon emission computed tomography. Of 604 publications identified, 22 met inclusion criteria. Twelve studies assessed bariatric surgery (seven gastric bypass, five gastric bypass/sleeve gastrectomy), and ten dietary interventions (six low-calorie diet, three very low-calorie diet, one prolonged fasting). Thirteen studies examined neurotransmitter systems (six used tracers for dopamine DRD2/3 receptors: two each for ¹¹ C-raclopride, ¹⁸ F-fallypride, ¹²³ I-IBZM; one for dopamine transporter, ¹²³ I-FP-CIT; one used tracer for serotonin 5-HT_2A receptor, ¹⁸ F-altanserin; two used tracers for serotonin transporter, ¹¹ C-DASB or ¹²³ I-FP-CIT; two used tracer for μ-opioid receptor, ¹¹ C-carfentanil; one used tracer for noradrenaline transporter, ¹¹ C-MRB); seven studies assessed glucose uptake using ¹⁸ F-fluorodeoxyglucose; four studies assessed regional cerebral blood flow using ¹⁵ O-H₂ O (one study also used arterial spin labeling); and two studies measured fatty acid uptake using ¹⁸ F-FTHA and one using ¹¹ C-palmitate. The review summarizes findings and correlations with clinical outcomes, eating behavior, and mechanistic mediators. The small number of studies using each tracer and intervention, lack of dietary intervention control groups in any surgical studies, heterogeneity in time since intervention and degree of weight loss, and small sample sizes hindered the drawing of robust conclusions across studies.

01 Nov 2023·Early Human Development

Neonatal stress exposure and DNA methylation of stress-related and neurodevelopmentally relevant genes: An exploratory study

Article

Author: Bos, Arend F ; Verkaik-Schakel, Rikst Nynke ; de Kroon, Marlou L A ; Bao, Mian ; Reijneveld, Sijmen A ; van Dokkum, Nienke H ; Plösch, Torsten

BACKGROUNDStress exposure during Neonatal Intensive Care Unit (NICU) stay may have long-lasting effects on neurodevelopmental outcomes in extremely preterm infants. Altered DNA methylation of stress-related and neurodevelopmentally relevant genes may be an underlying mechanism.AIMSThis exploratory study aimed to investigate the association between neonatal stress exposure and DNA methylation in these genes at two different time points: early during the NICU stay (7-14 days after birth) and later, at discharge from the NICU.SUBJECTSWe included 45 extremely preterm infants in this prospective cohort study, gestational age 24-30 weeks.OUTCOME MEASURESWe collected fecal samples at days 7-14 (n = 44) and discharge (n = 28) and determined DNA methylation status in predefined regions of NR3C1, SLC6A4, HSD11B2, OPRM1, SLC7A5, SLC1A2, IGF2, NNAT, BDNF and GABRA6 using pyrosequencing. Because of low DNA concentrations in some fecal samples, we could do so in 25-50 % of collected samples. We prospectively quantified daily neonatal stress exposure using the Neonatal Infant Stressor Scale (NISS) and explored associations between cumulative NISS scores and average DNA methylation status.RESULTSRates of methylation of most genes were not statistically different between day 7-14 and discharge, except for OPRM1. We found moderately high and mostly negative correlation coefficients upon discharge with the cumulative NISS for the NR3C1, SLC6A4, SLC1A2, IGF2, BDNF and OPRM1 genes, albeit not statistically significant.CONCLUSIONSFindings suggest that expression of stress-related and neurodevelopmentally relevant genes may be differently regulated following higher neonatal stress exposure. Larger studies should challenge the findings of this study and ideally test the effects on gene expression.

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