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Hungary

Medical Only (Private)

Reimbursed Care Access

Hungary maintains a restrictive legal regime for classic psychedelics: most tryptamines, phenethylamines and plant/fungal preparations (psilocybin, DMT, 5‑MeO‑DMT, MDMA, mescaline, ibogaine, ayahuasca, 2C‑X) are controlled and have no routine medical availability outside approved clinical research. Esketamine (Spravato) is authorised in the EU and listed in Hungarian product databases and can be delivered through licensed medical services; reimbursement pathways exist but are limited and administratively gated. Ketamine is legally available as an anaesthetic and is used off‑label in psychiatric practice (including private clinics), but routine public reimbursement for psychiatric ketamine therapy is not established and is handled case‑by‑case (named‑patient or special financing).

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Clinical Trials in Hungary

CompletedPhase IV

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

Open-label single-group long-term extension (n=183) assessing long-term safety and tolerability of intranasal esketamine plus SSRI/SNRI in participants with treatment-resistant major depressive disorder who completed prior esketamine study.

Started: April 26, 2021
Type: interventional
Blinding: none
Randomized: No
Registry ID: NCT04829318

CompletedPhase III

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)

This Phase III interventional trial (n=676) evaluated flexibly dosed esketamine nasal spray versus quetiapine XR, both with a continuing SSRI/SNRI, in participants with treatment-resistant major depressive disorder.

Started: August 21, 2020
Type: interventional
Blinding: none
Randomized: Yes
Registry ID: NCT04338321

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

CompletedPhase III

A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide (ASPIRE I)

Double-blind, randomised, placebo-controlled Phase III trial (n=226) testing intranasal esketamine 84 mg twice weekly for 4 weeks plus standard of care versus intranasal placebo plus standard of care for rapid reduction of MDD symptoms including suicidal ideation in adults at imminent suicide risk.

Started: June 9, 2017
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT03039192

CompletedPhase III

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (SUSTAIN-3)

Open-label, long-term extension Phase III safety study (n≈1148) of esketamine nasal spray (flexible 28–84 mg dosing) in participants with treatment-resistant depression, induction twice weekly for 4 weeks then individualised maintenance.

Started: June 9, 2016
Type: interventional
Blinding: none
Randomized: No
Registry ID: NCT02782104

CompletedPhase III

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression (TRANSFORM-1)

Randomized, double-blind, active-controlled Phase III study (n=346) comparing fixed-dose intranasal esketamine (56 mg or 84 mg) plus a newly initiated oral antidepressant versus intranasal placebo plus a newly initiated oral antidepressant in adults with treatment-resistant depression.

Started: August 10, 2015
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT02417064

Hungary

Reimbursed Care Access

Clinical Trials in Hungary

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)

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

A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide (ASPIRE I)

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (SUSTAIN-3)

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression (TRANSFORM-1)

Research Events

Company

Product

Legal

Hungary

Reimbursed Care Access

Clinical Trials in Hungary

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/​Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)

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

A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide (ASPIRE I)

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (SUSTAIN-3)

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression (TRANSFORM-1)

Research Events

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)