Trials
April 23, 2021
Robin J. Murphy, Rachael L. Sumner, William J. Evans et al.
23 citations
A proposed study will test whether regular low doses of LSD, known as microdosing, produce the cognitive and emotional benefits reported anecdotally. Eighty healthy men will receive either a placebo or 10 micrograms of LSD every third day for six weeks. The study will measure personality, creativity, mood, cognition, brain plasticity, and brain imaging at baseline and after the protocol, with additional acute measures after the first dose. Daily functioning will be tracked via questionnaires and a wearable device. The goal is to rigorously evaluate microdosing claims using objective measures, with potential future applications for treating depression, addiction, and other conditions.
Trials
May 2, 2024
Hailiang Zhang, Xiangrong Zhang, Xiaomei Jiang et al.
19 citations
A 10-week mindfulness-based intervention, combined with health education, helped reduce depression and anxiety symptoms and lower blood pressure in 60 hypertension patients with depression or anxiety. The intervention group showed a 21.1% reduction in depression scores and a 17.8% reduction in anxiety scores, along with a 12.24 mm Hg decrease in systolic blood pressure. Self-efficacy and awareness of physical and mental health also improved significantly compared to the control group, which received only health education. The findings suggest that short-term mindfulness programs can modestly relieve depression and anxiety, lower blood pressure, and improve psychological well-being in hypertensive patients with mood symptoms.
Trials
August 24, 2024
Dimitri Daldegan-Bueno, Carina Joy Donegan, Anna Forsyth et al.
14 citations
A phase 2b randomized controlled trial will test whether repeated low doses of LSD (4 to 20 micrograms, taken twice weekly for 8 weeks at home) reduce depressive symptoms in people with major depressive disorder, compared to an active placebo. The trial is triple-blind and includes measures of mood, personality, sleep, brain activity, blood biomarkers, and safety. This is the first controlled trial to test microdosed LSD in patients' natural environment. Results will help determine whether psychedelic microdosing is a viable additional treatment for depression and guide future research.
Trials
May 28, 2025
Veerle De Sloovere, Liese Mebis, Pieter Wouters et al.
9 citations
Ketamine, a sedative and analgesic, has been avoided in severe traumatic brain injury (TBI) due to a precaution about raising intracranial pressure (ICP). Observational studies and two meta-analyses do not suggest that ketamine increases ICP in sedated, mechanically ventilated TBI patients. The Brain Injury and Ketamine (BIKe) study is a planned prospective, multicenter, double-blind, placebo-controlled randomized trial. It will test whether adding ketamine (1 mg/kg/h continuous infusion) to standard sedation in 100 adult ICU patients with severe TBI is safe and reduces the need for other therapies to control ICP. The primary safety endpoint is the median number of high ICP episodes per ICU stay.
Trials
May 21, 2024
Chiranth Bhagavan, Paul Glue, Will Evans et al.
7 citations
A clinical trial will test whether MDMA-assisted therapy can reduce anxiety and depression in people with advanced-stage cancer. Up to 32 participants will be randomly assigned to receive either 120 mg of MDMA (with an optional 60 mg supplement) or a low dose of methylphenidate as a psychoactive control, each combined with therapeutic support sessions. The study will track mood, anxiety, quality of life, and other measures for up to 12 months. This research aims to establish the safety and effectiveness of a novel treatment for mental suffering in patients with life-threatening illness.
Trials
February 20, 2023
Javier García-campayo, Rinchen Hijar-Aguinaga, Yolanda López-del-hoyo et al.
6 citations
This protocol describes an exploratory randomized controlled trial designed to test whether four deconstructive meditative practices can improve well-being and promote self-deconstruction. The study will compare the effects of these practices, likely involving techniques that challenge the sense of self, against a control condition. Outcomes will include measures of well-being and self-deconstruction, with the aim of identifying which practices are most effective. The trial is exploratory, meaning it will generate preliminary data to inform future research. No results are reported as this is a study protocol.
Trials
April 17, 2025
Arash Mansoori, Amir Bazrafshan, Jamshid Ahmadi et al.
4 citations
For people with both major depressive disorder and opioid use disorder, a randomized clinical trial compared the effects of adding either ketamine or buprenorphine to standard treatments. Ketamine produced a rapid and substantial reduction in anxiety symptoms within hours, along with a pronounced decline in opioid craving. Buprenorphine led to a more gradual but sustained improvement in anxiety over several days, with a modest initial reduction in craving that persisted afterward. Both drugs reduced anxiety and craving, but through different time courses.
Trials
October 12, 2023
Winnie Lai-Sheung Cheng, Anson Chui-Yan Tang, Mark Cheuk-Man Tsang et al.
4 citations
A proposed randomized controlled trial will test whether a 6-week Music Breathing program—combining music listening and mindful breathing guided by a certified music therapist—can improve sense of coherence, a personal resource that helps mitigate stress and promote mental well-being. The study plans to recruit 290 young people aged 18–30, randomly assigning them to the Music Breathing program or a control condition of a Mental Health Education Programme. Outcomes include sense of coherence, coping self-efficacy, emotion regulation, mindfulness, depression, anxiety, stress, subjective well-being, and salivary cortisol. The results aim to inform stress-coping interventions for young people.
Trials
August 13, 2023
Irina Falkenberg, Florian Bitsch, Wei Liu et al.
4 citations
A study will investigate how treatment expectation influences the antidepressant effects of esketamine in patients with major depressive disorder (MDD). Using a fully balanced placebo design with factors of treatment (esketamine or placebo) and verbally induced expectation (high or low), combined with fMRI, the research aims to uncover the neural mechanisms—particularly in the lateral prefrontal cortex and rostral anterior cingulate cortex—underlying expectation effects and their interaction with esketamine's pharmacology. Insights may inform strategies to modulate placebo response in clinical trials and optimize treatment regimens that leverage expectation and drug synergy.
Trials
July 3, 2024
Joshua M Poulin, Gregory E Bigford, Krista L Lanctôt et al.
3 citations
A proposed randomized controlled trial will test whether a single 25 mg dose of psilocybin, compared to a placebo, acutely alters cerebral blood flow and functional brain activity in mood-regulating networks in people with major depressive disorder or persistent depressive disorder. Fifty participants from a mood disorders clinic will be randomly assigned to receive either psilocybin or a placebo, with the placebo group later crossing over to receive psilocybin. The study will use arterial spin labelling and blood oxygenation level-dependent functional MRI to measure brain changes intraday and at three weeks. Clinical outcomes will be tracked with the Montgomery-Åsberg Depression Rating Scale and other scales. The work aims to clarify psilocybin's neuroplastic mechanisms and identify early brain-based predictors of treatment response.
Trials
September 26, 2025
Xin-Ming Li, Si-Qi Hao, Xiu-Ru Qi et al.
2 citations
In patients at moderate-to-high risk of obstructive sleep apnea (OSA) undergoing painless gastroscopy, adding a low dose (0.25 mg/kg) of esketamine to propofol sedation may reduce dangerous oxygen drops (hypoxemia) compared to propofol alone. Esketamine, an NMDA receptor antagonist, is expected to lower the amount of propofol needed while keeping breathing more stable, and its side effects (like brief high blood pressure) should be mild. This single-center, double-blind, randomized controlled trial will enroll 294 adults with a STOP-Bang score of 3 or higher. The main outcome is the rate of hypoxemia (oxygen saturation below 90% for at least 10 seconds). The protocol aims to fill a gap in safer sedation for OSA patients.
Trials
October 6, 2023
Cátia Duarte, Ruben L F Spilker, Cláudia Paiva et al.
2 citations
A novel intervention combining mindfulness, acceptance, and compassion-based techniques (MITIG.RA) is being tested against treatment-as-usual for managing fatigue in rheumatoid arthritis patients who have not achieved full remission. Fatigue is a common, disabling symptom in this group, and current cognitive-behavioral treatments have limited effectiveness. This randomized controlled trial will enroll patients with PGA-near-remission and assess fatigue, disease impact, depression, and emotion-regulation skills at multiple time points over 44 weeks. The authors hypothesize that MITIG.RA will reduce fatigue and improve emotional well-being.
Trials
September 25, 2025
Anna Trippel, Ladina P Gubser, Etna Engeli et al.
1 citation
Cocaine is the most frequently used stimulant worldwide, with increasing consumption in Europe. Psychotherapeutic interventions for cocaine use disorder (CUD) show only modest effects, and no pharmacotherapy has been approved. A novel target, glutamatergic neurotransmission, emerged from animal models: after chronic cocaine, glutamate concentrations in the nucleus accumbens are reduced, with overflow during cue-induced cocaine-seeking. This imbalance has also been observed in humans. Neurofeedback training (NFT) studies using real-time functional magnetic resonance imaging (rt-fMRI) show participants with CUD can learn to regulate brain activity in reward areas using reward imagery.
Trials
May 26, 2025
Midas N de Grunt, Nurseda Risvanoglu, Johannes A Siegers et al.
1 citation
In a double-blind randomized non-inferiority trial, fentanyl given intravenously (IV) at 1.0 µg/kg is compared with fentanyl intranasally (IN) at 1.25 µg/kg, esketamine IV at 0.2 mg/kg, and esketamine IN at 0.625 mg/kg for acute traumatic pain in adults treated by Emergency Medical Services in the Netherlands. The primary outcome is pain reduction on a 0–10 Numeric Rating Scale at 10 minutes after the first dose, with a non-inferiority margin of 1.0. The trial aims to determine whether the alternative routes and drugs are as effective and safe as intravenous fentanyl, addressing a gap in comparative evidence for prehospital pain management.
Trials
May 13, 2025
Ka Yan, Nessa Ikani, Cleoputri Yusainy et al.
1 citation
Elevated stress, anxiety, and depression are common among Indonesian undergraduates, but access to mental healthcare is difficult and costly, and many avoid professional help. This randomized controlled trial tests whether a 14-day online mindfulness intervention reduces stress, anxiety, depressive symptoms, and repetitive negative thinking (RNT) compared to psychoeducation and waitlist controls. The study also examines whether changes in RNT explain mindfulness's effects on these outcomes. Measures are taken at baseline, post-intervention, and at a 3-month follow-up. The trial aims to provide evidence that a brief, accessible online mindfulness program could be a low-threshold strategy for improving mental health in Indonesia.
Trials
December 4, 2024
Qirong Sun, Jiao Luo, Shijia Zhang et al.
1 citation
Early postoperative pain and neurological dysfunction impair recovery after arthroscopic rotator cuff repair. Esketamine, an NMDA receptor antagonist, may reduce opioid use, inflammation, and protect nerves. This single-center, randomized controlled trial will enroll 234 patients undergoing arthroscopic rotator cuff repair, assigning them to general anesthesia with one of two doses of esketamine or saline. The primary outcome is quality of early recovery measured by the QoR-15 scale on postoperative day 1. Secondary outcomes include QoR-15 scores on day 3, remifentanil consumption, vasoactive drug use, cerebral desaturation, pain scores, delirium, and adverse events. The study aims to assess whether esketamine mitigates effects of controlled hypotension on cerebral oxygen saturation and postoperative delirium.
Trials
November 23, 2023
Grace Branjerdporn, Kerri Gillespie, Elizabeth Martin et al.
1 citation
A randomized controlled trial will test whether a mindfulness mobile app can improve mental health in pregnant women. The study will enroll 360 prenatal women from Mater Mothers' Hospital, assigning them to either use the app or receive usual care. Over 11 months, researchers will measure changes in postnatal depression, mother-infant bonding, and quality of life. A cost-effectiveness analysis will also be performed. Some participants will provide feedback in focus groups. Previous research suggests mindfulness can reduce stress, anxiety, depression, and sleep problems during pregnancy. The intervention carries low risk and may benefit women who cannot attend in-person appointments due to distance, cost, time, or health issues.