Malaysia

Medical Only (Private)

Reimbursed Care Access

Malaysia maintains a restrictive national framework for classical and novel psychedelics: most serotonergic/entheogenic compounds (psilocybin, MDMA, DMT, mescaline, 2C-X, 5‑MeO‑DMT, ibogaine, ayahuasca) are treated as controlled/illegal under national drug control policy with no authorized medical use outside approved research. Esketamine (SPRAVATO) is registered in Malaysia and is available through regulated medical channels; racemic/clinical ketamine is a controlled medicine used in clinical settings (largely as an anaesthetic and off‑label in individual private practices) but does not have broad public reimbursement for psychedelic/psychiatric indications.

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Clinical Trials in Malaysia

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 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 Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression (SUSTAIN-2)

Open-label, multicentre, single-group Phase III study (n=802) assessing long-term safety and efficacy of intranasal esketamine plus an oral antidepressant in adults with treatment-resistant depression.

Started: September 30, 2015
Type: interventional
Blinding: none
Randomized: No
Registry ID: NCT02497287

Malaysia

Reimbursed Care Access

Clinical Trials in Malaysia

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)

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 Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression (SUSTAIN-2)

Research Events

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Product

Legal

Malaysia

Reimbursed Care Access

Clinical Trials in Malaysia

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)

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 Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression (SUSTAIN-2)

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)