Swiss Medical Society for Psycholytic Therapy (SÄPT) Announces Data Demonstrating Reductions in Anxiety that Persist Through Two Years After Treatment with LSD
May 13 2024 - 7:00AM
Business Wire
-Remission Rates Maintained for One Year After
the End of the 50-week Placebo-Controlled Portion of the Study-
-LSD-Assist Study Collaboration Conducted by
Investigators from University Hospital Basel (UHB) and SÄPT-
-Updated Results Presented at the Society of
Biological Psychiatry (SOBP) Meeting, Original Study Recognized by
SOBP With Somerfeld-Ziskind Award for Outstanding Research
Investigations in Biological Psychiatry-
SÄPT today shared new data, presented by researchers this
weekend, which showed that long-term efficacy was maintained for
almost 2 years among adult patients participating in the LSD-Assist
Study that investigated the efficacy and safety of LSD in the
treatment of anxiety.
Data presented at the annual meeting of the SOBP in Austin,
Texas, demonstrated that 1 year after the conclusion of the
50-week-long placebo-controlled period of the LSD-Assist Study,
participants’ scores on the clinically validated State-Trait
Anxiety Inventory–Global (STAI-G), showed that remission rates
remained the same – 32% at week 50 vs. 33% at week 102.
“The statistically significant, rapid, strong and long-lasting
reductions in STAI-G scores, combined with similarly sustained
responses in all secondary endpoints are extremely encouraging,”
said Friederike Holze PhD, UHB, who presented the study. “While LSD
has shown beneficial effects on reducing anxiety, there has still
been a need for a deeper understanding of its long-lasting effects
and safety. This is why we designed a robust, randomized,
double-blind placebo-controlled clinical trial with a pre-planned
long-term follow-up period.”
In the 50-week placebo-controlled period of the LSD-Assist
study, the primary endpoint was achieved with LSD treatment
resulting in statistically significant and robust reductions of
STAI-G scores 16 weeks after treatment in the between-subjects
analysis (least square mean (± SE) change from baseline difference
= -16.2 (5.8), 95% CI=-27.8 to -4.5, p=0.007). Effects were maximal
2 weeks after the second LSD session and sustained throughout the
study.
Acute positive effects or mystical experiences significantly
correlated with long-term therapeutic outcomes at 16 weeks. LSD was
well-tolerated, with only one SAE that was considered related to
treatment, which consisted of acute transient anxiety and delusions
during an LSD session with a positive outcome for the patient.
There were no recorded instances of treatment-emergent suicidal
ideation with intent, suicidal behavior, or intentional
self-injury.
About the LSD-Assist Study
This investigator-initiated, two-center, clinical trial was a
double-blind, placebo-controlled, cross-over trial that
investigated the safety and efficacy of LSD for the treatment of
anxiety. The trial enrolled 46 patients either suffering from
anxiety symptoms with life-threatening illnesses or with an anxiety
disorder without severe somatic illness. Patients were randomly
assigned to two sessions, separated by 6 weeks, with either oral
LSD (200 μg) or placebo administration in the first period and vice
versa after the cross-over in the second period and were initially
followed for 50 weeks.
The primary efficacy endpoint was the reduction in anxiety
symptoms 16 weeks after the second LSD or placebo administration in
the first period. The primary outcome measure was the State-Trait
Anxiety Inventory (STAI) global score, which is used to assess the
severity of anxiety symptoms. Secondary outcome measures included
improvements in Hamilton Depression Scale (HAM-D-21), Beck
Depression Index (BDI), and several other major psychiatric
symptoms (Symptom-Check-List-90-R) scores. For additional
information on this trial see clinicaltrials.gov [NCT03153579].
Long-term Follow-up from LSD-Assist
The long-term data presented at SOBP were based upon an a
priori-planned long-term follow-up designed to help understand the
long-term impact of LSD on participants’ anxiety. Participants were
contacted 52 weeks after their last visit from the
placebo-controlled study for assessments utilizing the same
validated questionnaires administered in previous study visits.
This study revealed potential long-lasting benefits from LSD in
patients with anxiety, showing sustained improvements in anxiety
(STAI-G scores) 12 months post-study with no additional adverse
effects reported.
"We are pleased to see the results from this study persist for
the participants in this trial one year after its
placebo-controlled portion concluded and are encouraged that they
continue to benefit from their treatment,” added Peter Gasser, MD,
co-investigator of the study and President of SÄPT. “Dr. Holze and
I feel honored to receive SOBP’s Somerfeld-Ziskind award and thank
all the patients whose long-term participation made these findings
possible.”
About SÄPT, the Swiss Medical Society for Psychedelic
Treatment
The Swiss Medical Association for Psycholytic (Psychedelic)
Therapy was founded in 1985 and has now developed into a specialist
society with around 210 members, primarily from Switzerland and
Germany. Its statutory purpose is to make psychoactive substances
accessible for practical psychotherapeutic use, to control their
handling, to stimulate further research and to offer the
theoretical and practical training necessary for their
handling.
From 1988 to 1993, five SÄPT therapists received an exemption
from the Swiss Federal Office of Public Health (BAG) to carry out
psychedelic treatment with the substances MDMA and LSD in their
practices. During these five years, about 170 patients were
treated, undergoing just over a thousand full-day sessions, and the
results were published in 1996. Since then, SÄPT has conducted or
co-sponsored numerous studies and initiated the limited-use
program, which has given around 60 therapists the opportunity to
treat several hundred patients with psychedelic substances under
individual licenses over the last ten years. SÄPT has been led by
Dr. Gasser since 1997.
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