Placebo for Anxiety Disorders

3 papers and 30 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.

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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

3 papers

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: Barrow, R., Conant, C., Fava, M. F., Foster, E., Freedman, J. M., Jacobsen, P. L., Jemisen, J., Karas, S. M., Karlin, D. R., Robison, R., Solomon, T. M., Wernli, M. H.

Open Accessindividual

Self-blinding citizen science to explore psychedelic microdosing

Using a self‑blinding citizen‑science protocol in the largest placebo‑controlled microdosing study to date (n=191), the authors found psychological outcomes improved after four weeks but with no significant differences between microdose and placebo groups. Small acute and anxiety effects appeared due to participants breaking blind, suggesting reported benefits of microdosing are largely placebo‑driven and demonstrating the feasibility of a low‑cost self‑blinding approach.

Published: March 2, 2021
Journal: eLife
Authors: Blemings, A., Carhart-Harris, R. L., Erritzoe, D., Feilding, A., Kartner, L., Nutt, D. J., Rosas, F. E., Szigeti, B.

Open Accessindividual

A Randomized Add-on Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Bipolar Depression

This double-blind, placebo-controlled, randomised study (n=18) with those suffering from bipolar depression (BD; treatment-resistant) found that ketamine (35mg/70kg; 2x 2w apart) produced anti-depressant effects as measured on the MADRS scale. The effects were found immediately (40 minutes) and lasted up to three days.

Published: August 1, 2010
Journal: JAMA Psychiatry
Authors: Brutsche, N. E., Diazgranados, N., Ibrahim, L., Kammerer, W. A., Khalife, S., Kronstein, P., Luckenbaugh, D. A., Machado-Vieira, R., Manji, H., Newberg, A. B., Quezado, Z., Salvadore, G., Zarate, C. A.

Clinical Trials

30 trials

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

CompletedPhase II

Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder

This Phase IIa, multi-centre, double-blind, randomised, placebo-controlled trial (n=60) will investigate the safety, tolerability, and efficacy of EMP-01 in adults with social anxiety disorder (SAD). Participants will be randomised 1:1 to receive two administrations of either 225 mg EMP-01 or placebo on Day 1 and Day 29, with the primary endpoint assessed at Day 43.

Started: March 1, 2025
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT06693609

Not yet recruitingPhase III

PAPAYA: Pharmacologically-Assisted Psychotherapy for social Anxiety in Young people with Autism

This randomised, blinded, Phase III trial (n=156) will investigate MDMA-assisted psychotherapy (weight-based dosing with supplemental doses) versus dexamfetamine-, lorazepam-, diphenhydramine-, or placebo-assisted psychotherapy for social anxiety in autistic young people.

Started: January 15, 2025
Type: interventional
Blinding: single
Randomized: Yes
Registry ID: ACTRN12624001474549p

CompletedPhase I/II

Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI (5-MeO-DMT)

This Phase I/II randomised, triple-blind, placebo-controlled trial (n=20) will study the effects of sublingual 5-MeO-DMT (6 mg, administered weekly for four weeks) on anxiety, depression, and cognitive function in individuals with mild to moderate Alzheimer's disease.

Started: December 15, 2024
Type: interventional
Blinding: triple
Randomized: Yes
Registry ID: NCT06812221

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