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Home/Research/Placebo/Schizophrenia

Placebo for Schizophrenia

3 papers and 5 clinical trials exploring placebo as a treatment for schizophrenia.

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
IndicationApproximately 24 million people worldwide are affected by schizophrenia.

Schizophrenia

Schizophrenia is a complex psychiatric disorder characterised by disruptions in thought processes and perception. Recent research into psychedelics has opened new avenues for understanding its neurobiology and exploring potential therapeutic mechanisms, particularly in addressing treatment-resistant symptoms.

Full Schizophrenia profile

Academic Research

3 papers
Open Accessindividual

Cross-Species Evidence for Psilocin-Induced Visual Distortions: Apparent Motion Is Perceived by Both Humans and Rats

This cross-species experimental study (n=21 humans; n=10 rats) finds that psilocin (18.2mg/70kg for humans; 0.3mg/kg for rats) impairs the ability to distinguish between static and moving images in both humans and rats. In humans, the impairment aligns with psilocin plasma levels and self-reported hallucination intensity. In rats, the effect is specific to motion perception, providing the first evidence of psilocin-induced visual distortions across species.

Published
September 1, 2025
Journal
Biological Psychiatry
Authors
Vejmola, C., Šíchová, K., Syrová, K., Janečková, L., Koudelka, V., Tesař, M., Nikolič, M., Viktorin, V., Viktorinová, M., Tylš, F., Korčák, J., Kelemen, E., Nekovářová, T., Brunovský, M., Horáček, J., Kuchař, M., Páleníček, T.
Open Accessindividual

Pharmacological fMRI: Effects of subanesthetic ketamine on resting-state functional connectivity in the default mode network, salience network, dorsal attention network and executive control network

This randomised, double-blind, placebo-controlled cross-over study (n=17) investigates the effects of subanesthetic ketamine (105 mg/70kg) on resting-state functional connectivity in healthy male subjects and found an increase of connectivity between the executive control network (i.e. prefrontal cortex ) and other resting-state networks, such as the anterior cingulum and the frontal gyrus, and decreased connectivity between executive control network and salience network. Increased connectivity is taken to reflect positive psychotic symptoms (e.g. delusions, conceptional disorganization, hallucinatory behavior), whereas the decreased connectivity was taken to reflect negative psychotic symptoms (e.g. difficulties in abstract thinking, withdrawal) and as a sign of decreased visual perception in these subjects.

Published
May 1, 2018
Journal
NeuroImage
Authors
Mueller, F., Musso, F., London, M., De Boer, P., Zacharias, N., Winterer, G.
Open Accessindividual

Ketamine induces a robust whole-brain connectivity pattern that can be differentially modulated by drugs of different mechanism and clinical profile

This double-blind, placebo-controlled, cross-over, within-subjects study (n=22) investigated the effects of ketamine (30mg/70kg) on whole-brain functional connectivity in healthy male participants while attenuating pre-synaptic glutamate release directly via pretreatments with the sodium-channel modulator lamotrigine (300 mg), and indirectly via pretreatment with the 5-HT2A receptor antagonist risperidone (2mg). Ketamine induced robust changes in the functional connectivity pattern and produced a shift from a cortically-centered to a sub-cortically-centered brain state. Pre-treatment with risperidone, but not lamotrigine, resulted in a strong modulation of the ketamine-induced hub changes, which suggests that these changes are likely a result of NMDA blockade and possible serotonergic modulation rather than purely modulation of glutamate release.

Published
April 27, 2015
Journal
Psychopharmacology
Authors
Joules, R., Doyle, &. O. M., Schwarz, A. J., O'daly, O. G., Brammer, &. M., Williams, &. S. C., Mehta, M. A.

Clinical Trials

5 trials
RecruitingPhase III

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (INTENSIFY)

This randomized, controlled trial (n=1254) investigates the effect of an intensified pharmacological treatment (including ketamine/esketamine and clozapine) for schizophrenia, major depressive disorder (MDD), and bipolar depression in subjects who experienced a first-time treatment failure on their first-line treatment.

Started
March 31, 2024
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
NCT05603104
CompletedPhase III

Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study

Randomised, double-blind, crossover Phase III pilot (n=20) comparing IV esketamine (Ketanest S) versus active placebo (diphenhydramine) for negative and depressive symptoms in patients with schizophrenia-spectrum disorders.

Started
September 7, 2021
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
2019-004489-16
CompletedPhase II

Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia

Interventional, sequential Phase II dose-escalation study (n=37) assessing safety and EEG biomarkers of RL-007 (cohorts 10–80 mg, TID) with within-cohort placebo sequences in adults with schizophrenia.

Started
April 26, 2021
Type
interventional
Blinding
single
Randomized
No
Registry ID
NCT04822883
CompletedPhase I/II

Animal and human serotonergic model of schizophrenia: validity evaluated by qEEG and fMRI

Randomised, double‑blind, placebo‑controlled crossover study (n=40) testing a single oral psilocybin dose (18.2 mg/70 kg) versus placebo in healthy volunteers to model psychosis and assess fMRI/qEEG changes.

Started
June 18, 2014
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
2012-004579-37
Completed

Single Oral Lysergide (LSD 500 µg) in Inpatient Alcoholic Rehabilitation: Controlled Evaluation with Schizophrenic Sub-Analysis (Tomsovic & Edwards 1970)

This unregistered trial (n=75) was a partially randomised, placebo-controlled evaluation of a single 500 µg oral dose of LSD for alcohol use disorder in an inpatient rehabilitation setting, which found higher abstinence rates in non-schizophrenic participants at one year.

Started
January 1, 1966
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
TOMSOVIC-1970-QJSTUDIALCOHOL-LYSERGIDE-ALCOHOLICS

Explore further

Search all Placebo papers Search all Schizophrenia trials Full Placebo profile Full Schizophrenia profile