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Low dose injectable could aid prenatal depression
Research suggests that for every five mothers given low dose esketamine, one major depressive episode could be prevented.
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Depression
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Year in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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FDA approves first-in-class antidepressant
The first antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor has been approved for major depressive disorder (MDD) by the US Food and Drug Administration (FDA).
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DMT-SSRI combination shows potential for depression
A Phase Ib study evaluating selective serotonin reuptake inhibitors (SSRIs) interaction with SPL026, native N, N-dimethyltryptamine (DMT) in major depressive disorder (MDD) has revealed positive data.
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FDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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Psychedelic research: evaluating the fast-evolving regulatory roadmap
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
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Drug Delivery In-Depth Focus 2022
Articles explore the potential of tryptamines in treatment-resistant depression and drug delivery options for mRNA therapeutics.
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The potential of tryptamines in treatment-resistant depression
There is growing interest in the use of psychedelic-assisted therapy for treatment of mental health conditions. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial.
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Psilocybin improves depression symptoms, study shows
According to a new study, 25mg of psilocybin alongside psychological support, greatly reduces symptoms in participants with treatment-resistant depression.
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Zuranolone shows promise as episodic treatment for depression
Phase III data shows most major depressive disorder patients treated with zuranolone had minimal or mild depressive symptoms after a year.
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Intranasal anti-depressant drug successfully delivered to the brain
A new pre-clinical study succeeded in the intranasal delivery of an anti-depressant peptide-based drug to the brain in mouse models.
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Depression drug shows positive results in groundbreaking Phase IIb study
COMP360 25mg versus 1mg comparator dose demonstrated a -6.6 point difference on the Montgomery-Åsberg Depression Rating Scale by week 3.
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Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
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Regulators call for clinical research to include pregnant and breastfeeding women
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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Funding to support trial of ketamine in patients with bipolar depression
The Canadian Government is funding studies to establish ketamine as a safe and effective treatment for patients with bipolar depression.
