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Home/Research/Placebo/Immunology & Inflammation

Placebo for Immunology & Inflammation

1 paper and 5 clinical trials exploring placebo as a treatment for immunology & inflammation.

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
IndicationOver 264 million people worldwide suffer from depression, with a significant subset experiencing related inflammatory conditions.

Immunology & Inflammation

Recent research highlights the potential of psychedelics, particularly psilocybin and MDMA, in modulating immune responses and inflammation, shedding light on their therapeutic implications for mood disorders and other immune-related conditions. Studies are beginning to uncover the mechanisms through which these compounds exert anti-inflammatory effects and promote neuroplasticity, particularly in the context of major depressive disorder (MDD).

Full Immunology & Inflammation profile

Academic Research

1 paper
Open Accessindividual

Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin

This double-blind, randomised, placebo-controlled study (n=20) found that rapamycin (6mg, iv) extended the antidepressant effects (MADRS) of ketamine (35mg/70kg) at two weeks (41% higher response rate, 29% higher remission rate). This is contrasted to (animal/in vitro) studies that found opposing effects.

Published
February 24, 2020
Journal
Neuropsychopharmacology
Authors
Abdallah, C. G., Averill, L. A., Gueorguieva, R., Goktas, S., Purohit, P., Ranganathan, M., Sherif, M., Ahn, K. H., Cyril D'souza, D., Formica, R., Southwick, S. M., Duman, R. S., Sanacora, G., Krystal, J. H.

Clinical Trials

5 trials
RecruitingPhase NA

Antidepressant Response of DMT Masked With Propofol (DMT4D)

This randomised, placebo-controlled, quadruple-masked trial (n=112) will investigate whether the antidepressant effects of DMT (2 mg/min over 20 minutes; total ~40 mg) in patients with MDD depend on the subjective psychedelic experience by comparing DMT vs placebo under propofol sedation or no sedation.

Started
April 1, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06927076
RecruitingPhase II

Stress Experience Following Psilocybin (SEP-1)

This quadruple-blind, placebo-controlled trial (n=36) will investigate the role of stress response in shaping the positive effects of psilocybin (25mg or 1mg) by using metyrapone (750mg) to suppress cortisol production.

Started
February 1, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06768944
CompletedPhase I

Repeat Dosing of Psilocybin in Migraine Headache

Randomised, Phase I parallel study (n=18) testing single and repeated oral psilocybin (10 mg) vs diphenhydramine placebo across two sessions ~7 days apart to assess effects on migraine headache burden and mechanisms.

Started
July 15, 2021
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT04218539
Unknown statusPhase II

Psilocybin Versus Ketamine in Treatment-Resistant Depression (PSIKET_001)

Randomised, quadruple-blind Phase II parallel RCT (n=60) comparing single-dose oral psilocybin (25 mg) vs oral ketamine (250 mg) vs midazolam (5 mg) for treatment-resistant depression; primary outcome MADRS at 24 hours.

Started
May 1, 2021
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT05383313
CompletedPhase I/II

Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression

This randomised, placebo-controlled parallel trial (n=35) tested a single oral dose of ayahuasca versus placebo in patients with treatment-resistant depression.

Started
February 1, 2014
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT02914769

Explore further

Search all Placebo papers Search all Immunology & Inflammation trials Full Placebo profile Full Immunology & Inflammation profile