Active Trials

Total Trials

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Bulgaria

Medical Only (Private)

Reimbursed Care Access

Bulgaria maintains a restrictive legal regime for classical and novel psychedelics: most compounds (psilocybin, MDMA, DMT, 5‑MeO‑DMT, ibogaine, ayahuasca, mescaline, 2C‑X) are scheduled and have no authorised medical use outside of approved research, while ketamine remains an accepted medicinal anesthetic (and is used off‑label in psychiatry) and esketamine (Spravato®) is authorised in the EU and listed for reimbursement in Bulgaria under the National Health Insurance Fund (NHIF) with specific prescribing and supervision requirements. Clinical research is possible but tightly regulated and access outside trials is largely limited to licensed medical products and settings. Relevant regulatory oversight is exercised by the Ministry of Health and the National Council on Prices and Reimbursement / NHIF for reimbursement decisions; criminal enforcement of possession and trafficking is governed by Bulgarian narcotics control and penal provisions. [https://www.ema.europa.eu/en/medicines/human/EPAR/spravato|European Medicines Agency — Spravato] [https://www.pharmahelp.bg/home/productdetails?pcode=2741|PharmaHelp — Spravato (Bulgaria listing)] [https://lex.bg/bg/laws/ldoc/2135758694|Bulgarian law portal (drug control framework)].

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Clinical Trials in Bulgaria

TerminatedPhase II

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)

Double-blind, placebo-controlled Phase II trial (n=160) evaluating 25 mg psilocybin plus psychotherapy versus placebo in adults with Alcohol Use Disorder (AUD) over 24 weeks.

Started: June 1, 2022
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: 2021-006200-33

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

Bulgaria

Reimbursed Care Access

Clinical Trials in Bulgaria

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)

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)

Research Events

Company

Product

Legal

Bulgaria

Reimbursed Care Access

Clinical Trials in Bulgaria

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)

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)

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)