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Home/Research/Esketamine/Headache Disorders (Cluster & Migraine)

Esketamine for Headache Disorders (Cluster & Migraine)

11 papers and 0 clinical trials exploring esketamine as a treatment for headache disorders (cluster & migraine).

Compounddissociative

Esketamine

Esketamine (Spravato) is the S-enantiomer of ketamine, approved as an intranasal treatment for treatment-resistant depression and MDD with acute suicidal ideation. It is administered under clinical supervision with post-dose monitoring and has reached over $1.6 billion in annual sales.

Full Esketamine profile
IndicationOver 3 billion people globally.

Headache Disorders (Cluster & Migraine)

Psychedelics are being researched as potential treatments for headache disorders, including migraines and cluster headaches, which affect a significant portion of the global population. Early findings indicate that psychedelics may modulate pain perception and offer novel therapeutic pathways for those suffering from these debilitating conditions.

Full Headache Disorders (Cluster & Migraine) profile

Academic Research

11 papers
Open Accessindividual

Effect of Esketamine on Depressive Symptoms in Adolescents with Major Depressive Disorder at Imminent Suicide Risk: A Randomized Psychoactive-Controlled Study

This double-blind Phase IIb trial (n=147) evaluated the efficacy, safety, and tolerability of esketamine nasal spray versus midazolam in reducing depressive (MDD) symptoms in adolescents at imminent risk for suicide (SI). The study finds that pooled doses of esketamine (56 and 84 mg) significantly reduce depressive symptoms at 24 hours, with common side effects including dizziness, nausea, and dissociation.

Published
January 1, 2026
Journal
Journal of the American Academy of Child & Adolescent Psychiatry
Authors
Kosik-Gonzalez, C., Chen, L. N., Lane, R., Bloch, M. H., DelBello, M., Moreno, C., Drevets, W. C., Canuso, C. M., Fu, D. J.
Open Accessindividual

Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial

In a phase 4, multicentre, double-blind randomised trial in adults with treatment‑resistant depression, intranasal esketamine monotherapy (56 mg and 84 mg) produced significant reductions in MADRS score versus placebo at day 28 (LS mean differences −5.1 and −6.8; effect sizes 0.48 and 0.63) and demonstrated rapid benefit at 24 hours. The tolerability profile was consistent with prior reports, most commonly nausea, dissociation, dizziness and headache.

Published
September 1, 2025
Journal
JAMA Psychiatry
Authors
Janik, A., Qiu, X., Lane, R., Popova, V., Drevets, W. C., Canuso, C. M., Macaluso, M., Mattingly, G. W., Shelton, R. C., Zajecka, J. M., Fu, D. J.
Open Accessindividual

Safety Profile and Suicidality Associated with the Use of Esketamine in the Treatment of Major Depressive Disorder in European Countries: An EudraVigilance Database Analysis

This pharmacovigilance analysis (n=751) examines suspected adverse reactions (SARs) to esketamine nasal spray (Spravato) reported in the EudraVigilance database across European countries. The study identifies increased blood pressure (15.4%) and dissociation (15%) as the most common SARs, with data suggesting a potentially higher risk of suicidality with esketamine compared to fluoxetine and venlafaxine, prompting recommendations for careful monitoring of patients with a history of suicidal ideation.

Published
May 9, 2025
Journal
Pharmaceuticals
Authors
Ammendolia, I., Mannucci, C., Esposito, E., Calapai, G., Currò, M., Midiri, P., Mondello, C., Cardia, L., Calapai, F.
Open Accessindividual

Safety and Efficacy with Esketamine in Treatment-Resistant Depression: Long-Term Extension Study

In the phase 3 SUSTAIN-3 long-term extension (1,148 patients, 3,777 patient‑years), intermittent intranasal esketamine plus an oral antidepressant showed no new safety signals and an adverse event profile consistent with earlier studies. Depression severity improved during induction and was generally maintained during optimisation/maintenance, with remission in 35.6% at induction and about 48–50% at week 112/maintenance endpoint.

Published
May 4, 2025
Journal
International Journal of Neuropsychopharmacology
Authors
Zaki, N., Chen, N. )., Lane, R., Doherty, T., Drevets, W. C., Morrison, R. L., Sanacora, G., Wilkinson, S. T., Young, A. H., Chb, M. B., Lacerda, A. L. T., Paik, J. W., Popova, V., Fu, D. J.
Paywallindividual

Effect of Repeated Intravenous Esketamine on Adolescents With Major Depressive Disorder and Suicidal Ideation: A Randomized Active-Placebo-Controlled Trial

This placebo-controlled trial (n=54) investigates the efficacy and safety of esketamine (iv, 17.5mg, 3x) in adolescents suffering from depression (MDD) and suicidal ideation (SI). It shows significant reductions in Columbia Suicide Severity Rating Scale (C-SSRS) Ideation and Intensity scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores in the esketamine group compared to the midazolam (placebo) group at day six, with maintained antisuicidal and antidepressant responses at four weeks post-treatment.

Published
May 1, 2024
Journal
Child and Adolescent Psychiatry
Authors
Zhou, Y., Lan, X-F., Wang, C., Zhang, F., Liu, H., Chao, Z., Ning, Y-P., Fu, L., Hu, Z., Li, W., Ye, Y.
Paywallmeta

A comparison between psilocybin and esketamine in treatment-resistant depression using number needed to treat (NNT): A systematic review

This systematic review (s=5) of randomised controlled trials (RCTs) compares oral psilocybin (25mg) and intranasal esketamine (56-84mg) with an oral antidepressant in adults with depression (TRD). The review showed significant depressive symptom reduction with psilocybin (Number Needed to Treat; NNT=5) and esketamine (NNT=7). Psilocybin has a Number Needed to Harm (NNH) of 5 for nausea, while esketamine induces mild side effects (NNH<10).

Published
April 1, 2024
Journal
Journal of Affective Disorders
Authors
Wong, S., Kwan, A. T. H., Teopiz, K. M., Le, G. H., Meshkat, S., Ho, R., D', G., Cao, B., Vincenzo, J. D. D., Rosenblat, J. D., Mcintyre, R. S.

Clinical Trials

0 trials

No clinical trials have been tagged with both Esketamine and Headache Disorders (Cluster & Migraine) yet.

Trials are continuously being added as new studies are registered.

Explore further

Search all Esketamine papers Search all Headache Disorders (Cluster & Migraine) trials Full Esketamine profile Full Headache Disorders (Cluster & Migraine) profile