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FDA advisors recommend intranasal ketamine in depression

February 20, 2019

…ketamine abuse in the U.S. is reportedly low (1.3%). While efficacy claims were only supported by one short-term study (TRANSFORM-2) and a maintenance trial (SUSTAIN-1), the FDA advisors determined that the benefits outweighed the risks in this difficult-to-treat study population. Also working in the drug’s favour were its rapid onset of action, and a lack of alternatives for TRD. The committees’ recommendation for approval will now be forwarded t…

Always online: problem or addiction?

February 13, 2019

…th attention deficit-hyperactivity disorder, depression, anxiety, obsessive-compulsive symptoms, and hostility/aggression (Carli et al. Psychopathology 2013;46:1-13). The plethora of associations likely obscures the distinction between Internet usage as a means of coping with pre-existing psychiatric symptoms and psychosocial dysfunction versus being a cause of psychiatric symptoms. With respect to coping, one study reported that phobic anxiety, w…

Hockey and head injury – report

February 6, 2019

…sion Test (SCAT5) to evaluate symptoms, cognition and balance, and the King-Devick Test (KDT) of cognition. In a medical setting, diagnosis is based on an evaluation of the timing and mechanism of head impact, risk factors, prior history of concussion, signs/symptoms such as loss of consciousness and amnesia, and duration of symptoms. Tests include the Symptom Severity Score (a 6-point change from baseline is meaningful); SCAT5 or the Montreal Cog…

Two trials terminated in Alzheimer’s disease

January 31, 2019

…ght be effective. In the preplanned analysis of the phase III studies, the data monitoring committee found that treatment was unlikely to improve CDR-SB scores despite dosing that was four times higher than what was used in the phase II study. Crenezumab was discovered by Immune SA, which licensed it to Genentech; the U.S. biotech was subsequently acquired by Roche. Two other MAbs targeting beta-amyloid have met a similar fate. Elan terminated the…

Phase III trials in neurology – 2018 in review

January 24, 2019

…ps://thejournalofheadacheandpain.biomedcentral.com/track/pdf/10.1186/s10194-018-0951-2). Two regimens were examined: 240 mg loading dose s.c. followed by 120 mg/month; and 240 mg/month s.c. In episodic migraine, ≥50% response was maintained for >3 months in 41.5% (120 mg) and 41.1% (240 mg) of patients in the galcanezumab groups versus 21.4% with placebo. Response was maintained for >6 months in 19.0% and 20.5% of patients in the galcanezumab grou…