Greece

Medical Only (Private)

Reimbursed Care Access

Greece maintains a restrictive controlled‑substances regime under Law 4139/2013; licensed pharmaceutical psychedelics that have EU marketing authorisations (currently esketamine/Spravato) are available under tight clinical controls, but routine public reimbursement and broad medical access for classic psychedelics (psilocybin, MDMA, DMT, etc.) do not exist outside approved clinical research. Off‑label clinical use of ketamine for anesthesia and some private off‑label psychiatric uses occurs, but most other compounds remain scheduled with no authorized medical use outside clinical trials or special authorised programmes.

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Clinical Trials in Greece

RecruitingPhase III

A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder (EMBRACE)

Phase III, quadruple-blind, randomised, placebo-controlled trial (n=330) of CYB003 (8 mg and 16 mg; two dosing sessions ~3 weeks apart) as adjunctive treatment for major depressive disorder.

Started: July 8, 2025
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT06793397

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 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

Research Events

Organizations1

EPOPTEIA

Hellenic Center for Entheogenic Research

Greece

Reimbursed Care Access

Clinical Trials in Greece

A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder (EMBRACE)

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)

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)

Research Events

Organizations1

EPOPTEIA

Company

Product

Legal

Greece

Reimbursed Care Access

Clinical Trials in Greece

A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder (EMBRACE)

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)

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)

Research Events

Organizations1

EPOPTEIA

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)