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Home/Research/Placebo/Anxiety Disorders

Placebo for Anxiety Disorders

20 papers and 43 clinical trials exploring placebo as a treatment for anxiety disorders.

CompoundComparator / Control

Placebo

Placebo is the most widely referenced comparator in psychedelic clinical research, appearing in over 500 trials. Understanding how placebos are designed, administered, and interpreted is essential to evaluating the evidence base for psychedelic-assisted therapies — and one of the field’s most contested methodological challenges.

Full Placebo profile
Indication300 million worldwide

Anxiety Disorders

Anxiety disorders, affecting around 300 million people globally, are among the most prevalent mental health conditions. Emerging clinical research suggests that various psychedelics, including psilocybin, MDMA, and LSD, hold potential for alleviating anxiety symptoms through innovative therapeutic approaches.

Full Anxiety Disorders profile

Academic Research

20 papers
Open Accessindividual

MDMA-Assisted Therapy for Social Anxiety Disorder: A Randomized, Open-label, Wait-list Controlled Trial

This randomised, open-label, wait-list-controlled trial (n=20) found that MDMA-assisted therapy reduced social anxiety symptoms more than waiting for treatment and improved functioning in adults with social anxiety disorder (SAD).

Published
June 4, 2026
Journal
Psyarxiv
Authors
Luoma, J. B., Lear, M. K., Pilecki, B., Lejeune, J., Yi, K., Chwyl, C., Mehr, S., Sarparast, A., Kennedy, L., Lucas, W., Spata, A., Stauffer, C.
Paywallindividual

Changes in anxiety, quality of life, and functioning following psilocybin-assisted therapy in veterans with treatment-resistant depression

This secondary analysis of an open-label trial (n=15) examined a single 25 mg dose of psilocybin with psychological support in veterans with treatment-resistant depression, focusing on anxiety, quality of life, functioning, and PTSD symptoms. Improvements were observed across these measures, but most were no longer significant after accounting for concurrent improvements in depression.

Published
June 4, 2026
Journal
Journal of Affective Disorders
Authors
Kelly, C. M., Fradet, M., Bostian, C. M., Donnelly, A., Ellis, S., Ostacher, M., Aaronson, S., Suppes, T.
Open Accessindividual

Short-Term and Late-Term Effects of Psilocybin on Symptoms in Major Depression: A Randomized Clinical Trial.

This double-blind placebo-controlled randomised clinical trial (n=35) found that a single 25 mg dose of psilocybin, given with psychotherapy, reduced depression symptoms in people with moderate to severe recurrent major depressive disorder within days and for more than three months on some measures. Most side effects were mild or moderate, but two participants had severe anxiety that needed medical attention.

Published
May 15, 2026
Journal
JAMA Network Open
Authors
Yngwe, H., Plavén-Sigray, P., Ekman, C. J., Henje, E., Berglund, A., Tiger, M., Beckman, M., Lundberg, J.
Open Accessindividual

A phase 1 study of a second experience with Group Retreat Psilocybin Therapy for partial responders after a first experience

This Phase 1 study (n=13) tested a second group retreat psilocybin therapy session in people with metastatic cancer who had only partly responded before. It found no serious side effects, and anxiety and depression scores improved, with more participants reporting a full mystical experience after the second session.

Published
April 14, 2026
Authors
Back, A. L., McGregor, B. A., Thorn, L. L., Harvey, K., Blom, D., Callan, G., Guy, J., Kumar, S., Hershberg, R., Layer, M., Levin, J., Myers, S., Perez, J., Salmonson, K., Thompson, P., Whinney, J.
Open Accessindividual

It's all about the relationship: The caregiver experience of supporting a person with advanced cancer going through an LSD microdosing trial

This secondary analysis of an RCT (n=15 interviews) found that caregivers of people with advanced cancer were generally supportive of participation in an LSD microdosing plus meaning-centred psychotherapy trial, though some were initially hesitant. It highlighted the bidirectional nature of patient-caregiver well-being, with the intervention seen as offering hope, easing existential distress, and strengthening their relationship.

Published
February 26, 2026
Journal
Palliative & Supportive Care
Authors
Cottam, F., Wells, A., Clayden, C., Reynolds, L.
Paywallindividual

Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial

In a multicentre phase 2b randomised placebo‑controlled trial of 198 adults with moderate to severe GAD, a single dose of MM120 (lysergide D‑tartrate) produced a dose‑dependent reduction in HAM‑A scores at 4 weeks, with 100 µg and 200 µg showing significant improvements versus placebo (least‑squares mean differences −5.0 and −6.0 points, respectively). Adverse events were dose‑related—most commonly visual perceptual changes and nausea—supporting the efficacy and informing dose selection for phase 3 trials.

Published
October 21, 2025
Journal
JAMA
Authors
Robison, R., Barrow, R., Conant, C., Foster, E., Freedman, J. M., Jacobsen, P. L., Karas, S. M., Karlin, D. R., Solomon, T. M., Wernli, M. H., Fava, M. F., Jemisen, J.

Clinical Trials

43 trials
CompletedPhase II

A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1)

This Phase II, two-part, multicentre trial (n=64) will assess methylone as a treatment for adults with post-traumatic stress disorder (PTSD). It is designed to evaluate the drug’s safety, tolerability, and efficacy in participants aged 18–65 years in the UK, including people who have previously tried at least one PTSD treatment without sufficient benefit.

Type
interventional
Blinding
double
Randomized
Yes
Not yet recruitingPhase II

NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

This Phase II, randomised, open-label, parallel trial (n=83) will assess whether prophylactic psilocybin prevents or mitigates chemotherapy-induced peripheral neuropathy (CIPN) in adults receiving adjuvant neurotoxic chemotherapy (taxanes or platinum agents) for breast, colorectal, or head and neck cancers; the primary outcome is the proportion of participants with a ≥25% worsening from baseline to Week 12 on the EORTC QLQ-CIPN20 sensory subscale. Participants are randomised to one of three arms: Arm A receives supervised oral psilocybin 25 mg given as four doses (two pre-chemotherapy doses one week apart on Day 7 and Day 14, then two monthly doses prior to chemotherapy cycles 2 and 3 on Day 42 and Day 70); Arm B receives subperceptual oral psilocybin 1mg administered every other day during a two-week pre-chemotherapy run-in (mailed as 7×1 mg capsules in tamper-evident packaging) with dosing continued prior to the first three cycles (total 21 doses); Arm C receives standard of care with no study drug. The primary analysis compares 25 mg versus pooled control (standard of care plus 1 mg), tested two-sided at α=0.05 with confirmatory pairwise tests (25 mg vs SOC; 25 mg vs 1 mg) using Hochberg adjustment if significant. Key secondary objectives include rates of chemotherapy dose modifications for neurotoxicity, NCI-CTCAE measures of CIPN, and effects on quality of life and psychosocial outcomes assessed with instruments such as PROMIS-10, PROMIS-A, PROMIS-D, FACT-Cog, PSQI, BFI, MDASI, MEQ30 and the Flourishing scale. Eligible participants are adults (≥18 years) with ECOG 0–2, no pre-existing peripheral neuropathy greater than Grade 1, and scheduled for relevant chemotherapy; safety and adverse events are followed through study completion (average 1 year).

Started
May 4, 2026
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT07227909
Not yet recruitingPhase IV

Effects of different doses of esketamine on postoperative delirium and postoperative cognitive function in elderly gastrointestinal tumor patients with preoperative anxiety

This parallel, Phase 4 interventional trial in China (n=136) is investigating the effects of different doses of esketamine on postoperative delirium and postoperative cognitive function in elderly patients with gastrointestinal tumours who have preoperative anxiety. Participants aged 60 to 80 years, of both sexes, are being assigned to one of three esketamine dose groups (0.15 mg/kg, 0.25 mg/kg, or 0.5 mg/kg) or a placebo control group. The study is designed to compare whether lower or higher perioperative doses of esketamine influence neurocognitive recovery after surgery. The primary outcomes are postoperative delirium and postoperative cognitive function, assessed after the operation; the registry record does not specify the exact assessment timepoints. Secondary outcomes include anxiety, haemodynamic adverse events, intraoperative vital signs, postoperative pain, intraoperative propofol and remifentanil requirements, emergence agitation, and serum concentrations of interleukin-6, S100ß, and neuron-specific enolase. Sponsored by The Central Hospital of Wuhan, this trial reflects ongoing clinical research in China evaluating esketamine as a potential perioperative adjunct in older surgical patients at risk of neurocognitive complications.

Started
August 1, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
ChiCTR2500106981
RecruitingPhase III

Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)

Phase III, randomized, quadruple-blind, placebo-controlled parallel-arm RCT (n=120) testing psilocybin microdosing (2–3 mg, 4 days/week for 2 weeks) versus placebo to reduce psychological and existential distress in patients receiving palliative care.

Started
August 1, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT07063862
RecruitingPhase II

Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder

This Phase IIa, placebo-controlled, double-blind trial (n=50) will study the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin (oral solution) in adults with generalised anxiety disorder (GAD).

Started
May 6, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06969170
Not yet recruitingPhase II

A Mechanistic Study to Assess a Single Dose of CYB003 in Participants with Depression and Anxiety

This randomised, triple-blind, placebo-controlled Phase II mechanistic trial (n=40) will assess a single 16 mg oral dose of CYB003 versus placebo on brain activity and connectivity in participants with MDD and moderate-to-severe anxiety.

Started
March 1, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06820723

Explore further

Search all Placebo papers Search all Anxiety Disorders trials Full Placebo profile Full Anxiety Disorders profile