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Stay up to date with the latest research papers, clinical trials, blog posts, and site updates.
This systematic review (s=23) examined manic or hypomanic symptoms following use of serotonergic psychedelics or MDMA, and found rates of dysphoria, euphoria, or mania ranging from about 6% in controlled psilocybin trials to 30% in naturalistic studies of people with bipolar disorder. Manic symptoms were usually acute and self-limited, with higher risk among people with bipolar I, familial vulnerability, polysubstance use, or unsupervised use.
This double-blind randomised controlled trial (n=120) in healthy volunteers assessed how well blinding held when people received psilocybin, MDMA, or methylphenidate as an active placebo, and found blinding was generally insufficient. Functional unblinding was highest for psilocybin, moderate for MDMA, and lowest for methylphenidate.
This Phase I, randomised, triple-masked, parallel-group trial (n=90) will evaluate whether a single oral dose of psilocybin 25 mg can improve residual anhedonia and emotional blunting in adults with major depressive disorder who remain symptomatic despite ongoing SSRI or SNRI treatment. The study will compare psilocybin with placebo and will assess whether treatment can restore fronto-striatal reward circuit function and reduce anhedonia. Participants in both arms will complete six MRI sessions, with two scans before the administration day and four afterwards. The psilocybin group will receive a supervised one-time 25 mg capsule dose, while the control group will receive a matching placebo capsule containing 25 mg of inert filler. Key outcomes include change in Dimensional Anhedonia Rating Scale score and change in fronto-striatal connectivity (pgACC-NAcc functional connectivity) from baseline to end of study, with assessments planned from week -3 to week 8.
This Phase II, randomised, quadruple-masked, parallel-group trial (n=40) will evaluate oral psilocybin therapy for depression in people with Parkinson’s disease. The study will assess whether two psilocybin administration sessions, delivered in a monitored setting with psychotherapeutic support, improve depressive symptoms and other clinical outcomes in participants with early to moderate Parkinson’s disease and moderate or greater depression. Participants with Hoehn and Yahr stage 1–3 Parkinson’s disease and a baseline Beck Depression Inventory-2 score of at least 20 will receive one dose of psilocybin ranging from low (“microdose”) to high in each of two drug administration sessions, with preparation psychotherapy before and integration sessions after. Outcomes will include change in depression measured by the Montgomery-Asberg Depression Rating Scale from baseline to 30 days after the first dose, as well as safety, tolerability, non-motor and motor symptoms of Parkinson’s disease, cognitive performance, and quality of life, with follow-up continuing for 3 months after the second session.
This prospective observational pilot study (n=5) will assess whether continuous wearable physiological monitoring can characterise an intra-sessional autonomic arc during ketamine-assisted therapy in adults with post-traumatic stress disorder (PTSD). It will evaluate the feasibility of detecting a consistent autonomic trajectory, using continuous heart rate variability (HRV) and electrodermal activity (EDA) data collected during independently arranged ketamine sessions. Participants aged 19 years or older with confirmed PTSD will wear an EmbracePlus wrist-worn biosensor across a 3–7 day pre-session baseline period, the full ketamine-assisted therapy session, and 3–5 day follow-up monitoring windows at 1, 2 and 4 weeks after the session. The study also includes a structured pre-session interview within 48 hours before treatment and a structured post-session interview within 4 hours after session end, including administration of the Post-Session Subjective Integration Scale. Ketamine is administered solely by the participant’s licensed treating provider, and no drug is given by the researcher. The primary outcome is intra-sessional autonomic arc trajectory characterisation during the ketamine session, with sessions showing EDA channel loss exceeding 15% of the recording window excluded from primary analysis.
This observational study (n=11) of people with chronic cluster headache examined three doses of psilocybin (10 mg/70 kg) and found that self-reported sleep quality improved after treatment. Brain scans showed differences in microstructure and water diffusivity between patients and healthy controls, but psilocybin did not produce clear average changes in these measures.
This randomised, double-blind, placebo-controlled trial (n=60) will assess whether an intranasal dexmedetomidine-esketamine combination improves sleep quality and cognitive function in older adults aged 60 years and above with mild-to-moderate cognitive impairment and comorbid sleep disorder. The main aim is to evaluate change in Pittsburgh Sleep Quality Index (PSQI) score 1 month after the intervention. Participants will receive either the dexmedetomidine-esketamine nasal spray, calculated at approximately 0.4 μg/kg of dexmedetomidine plus 0.2 mg/kg of esketamine, or an equal volume of 0.9% normal saline placebo. Administration uses a customised nasal spray device with alternating nostrils every 5 minutes until the target dose is reached, given twice a week for 4 consecutive weeks (8 sessions in total). Safety monitoring during treatment includes ECG, blood pressure, blood oxygen levels and consciousness, and sleep will be recorded by actigraphy on treatment nights, with face-to-face follow-up at 1, 2 and 3 months after treatment to assess sleep, cognition, mood and activities of daily living.
This exploratory brain imaging study (n=9) examined resting-state fMRI connectivity before and after ayahuasca and found a small drop in one measure of topological complexity in the main analysis, but this did not hold up after correction and was not seen when signed correlations were used. Exploratory measures of signal complexity rose slightly but not significantly.
This Phase I intervention trial (n=120) investigates whether stimulating the serotonin system influences pro-social behaviour compared to stimulating the dopamine system in healthy individuals; single-dose psilocybin (15 mg), MDMA (100 mg) or methylphenidate (60 mg) in a double-blind randomized parallel design.
ScienceDirect
This parallel, Phase IV interventional trial in China (n=120) is evaluating whether esketamine can reduce postoperative sleep disorders in adults with thyroid cancer. Participants are allocated to three groups: low-dose esketamine (0.3 mg/kg intravenously before anaesthesia induction), high-dose esketamine (0.5 mg/kg intravenously before anaesthesia induction), or an equivalent volume of intravenous normal saline as control. The study includes men and women aged 18 to 60 years. The primary outcomes are insomnia severity measured by the Athens Insomnia Scale (AIS) and assessed postoperatively at the prespecified follow-up timepoints. Secondary outcomes include sleep quality measured by the Richards-Campbell Sleep Questionnaire (RCSQ), anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS), and pain intensity measured with the Numerical Rating Scale (NRS). This trial is designed to clarify whether perioperative esketamine improves sleep-related recovery after thyroid cancer surgery compared with placebo, and whether the higher dose provides additional benefit. The study is sponsored by the Affiliated Hospital of Zunyi Medical University.
Carhart-Harris et al., 2021