Italy

Medical Only (Private)

Reimbursed Care Access

Italy maintains a largely prohibition‑based approach to classical psychedelics: most classic hallucinogens (psilocybin, MDMA, mescaline, DMT, 5‑MeO‑DMT, 2C‑X, ibogaine, ayahuasca) are controlled under the DPR 309/1990 framework and may only be accessed in authorised clinical research or via tightly regulated medical channels when a licensed medicinal product exists. The one broadly available, reimbursed pharmaceutical in the psychedelic-adjacent space is esketamine (Spravato), which is classified for hospital use with national reimbursement (AIFA Class H); ketamine itself remains a controlled medicine used in hospital/clinical settings and in private off‑label practice for indications like anaesthesia and, in some private clinics, for treatment‑resistant depression but is not reimbursed by the SSN for that psychiatric indication. Citations to primary Italian regulatory acts and official Gazzetta/Ufficiale determinations are included inline below for each compound entry.

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Clinical Trials in Italy

RecruitingPhase III

Ketamine Augmentation of ECT in Treatment-Resistant Depression (Ketamina)

Phase III double-blind, randomised, placebo-controlled trial (n=30) testing IV ketamine 0.5 mg/kg given during ECT sessions 2, 4 and 6 in hospitalised adults with treatment-resistant MDD.

Started: July 10, 2025
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT07088380

RecruitingPhase III

The Effect of a Four Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. (INTENSIFY MDD)

Open-label, randomised, parallel trial with blinded raters (n=418) comparing early-intensified pharmacological treatment including esketamine or ketamine (twice-weekly for 4 weeks) plus a second-line antidepressant versus treatment as usual in adults (18–65) with MDD and first-line treatment failure.

Started: March 31, 2024
Type: interventional
Blinding: single
Randomized: Yes
Registry ID: NCT05973851

CompletedPhase II

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

This double-blind, randomized, psychoactive placebo-controlled trial (n=147) assessed the efficacy and safety of 3 fixed doses (28 mg, 56 mg, and 84 mg) of intranasal esketamine in addition to comprehensive standard of care for rapidly reducing the symptoms of major depressive disorder (MDD), including suicidal ideation, in pediatric subjects.

Started: October 5, 2017
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT03185819

Italy

Reimbursed Care Access

Clinical Trials in Italy

Ketamine Augmentation of ECT in Treatment-Resistant Depression (Ketamina)

The Effect of a Four Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. (INTENSIFY MDD)

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

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