Lysergic Acid Diethylamide–Assisted Therapy in Patients With Anxiety With and Without a Life-Threatening Illness: A Randomized, Double-Blind, Placebo-Controlled Phase II Study
Biological Psychiatry(2023)
摘要
Background
This study aimed to investigate the efficacy and safety of lysergic acid diethylamide (LSD)–assisted therapy in patients who experienced anxiety with or without association with a life-threatening illness.
Methods
The study is an investigator-initiated 2-center trial that used a double-blind, placebo-controlled, 2-period, random-order, crossover design with 2 sessions with either oral LSD (200 μg) or placebo per period. The primary end point was anxiety symptoms 16 weeks after the last treatment session, assessed by the Spielberger State-Trait Anxiety Inventory–Global score in 42 patients. Further outcome measures included ratings for depression symptoms (Beck Depression Inventory and Hamilton Depression Rating Scale, 21-item version) and ratings for acute subjective drug effects. The outcomes for the first period (between-subjects analysis) are primarily shown due to carryover effects.
Results
LSD treatment resulted in significant reductions of State-Trait Anxiety Inventory–Global scores up to 16 weeks after treatment (least-square mean [standard error] change from baseline difference = −16.2 [5.8], 95% CI, −27.8 to −4.5, d = −1.18, p = .007). Similar effects were observed for ratings of comorbid depression on the Hamilton Depression Rating Scale, 21-item version (−7.0 [1.9], 95% CI, −10.8 to −3.2, d = −1.1, p = .0004) and the Beck Depression Inventory (−6.1 [2.6], 95% CI, −11.4 to −0.9, d = −0.72, p = .02). Positive acute subjective drug effects and mystical-type experiences correlated with the long-term reductions in anxiety symptoms. Transient, mild, acute untoward effects of LSD treatment were reported by 8 patients (19%). One treatment-related serious adverse event (acute transient anxiety) occurred (2%).
Conclusions
LSD produced long-lasting and notable reductions in anxiety and comorbid depression symptoms up to 16 weeks.
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关键词
Anxiety,Depression,Life-threatening-illness,LSD,Psychedelics,RCT
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